Juvenile Idiopathic ArthritisPhase 3NCT00775437

Active Juvenile Idiopathic Arthritis (JIA) Compassionate Use

A Phase 3 study testing Adalimumab in people with Juvenile Idiopathic Arthritis, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objective of this study is to evaluate the safety of adalimumab in patients 2 to < 4 years of age or ≥ 4 years of age weighing < 15 kg, with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) or polyarticular course JIA. Read more about this study

Who is it for?: Ages 2 to 4 years
Conditions the study is for: Juvenile Idiopathic Arthritis
What is being tested?: Adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: No sites listed yet
Study dates: Mar 2009to Mar 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 4 years
All sexes
No healthy volunteers
Child

Who may be able to join

A parent or guardian has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject's parent or legal guardian has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed or before any medication is discontinued for the purpose of this study. The parent must also be willing to comply with all the requirements of this study protocol.
Subject has a disease diagnosis of moderately to severely active polyarticular or polyarticular course juvenile idiopathic arthritis (JIA; defined as arthritis affecting > = 5 joints at the time of treatment initiation). This corresponds to the International League of Associations for Rheumatology categories of polyarticular rheumatoid factor positive (RF+), polyarticular Rheumatoid factor negative (RF-) disease, and extended oligoarthritis disease.
Subject must be aged 2 to < 4 years old with moderately to severely active polyarticular JIA or polyarticular course JIA or age 4 or greater weighing < 15 kg with moderately to severely active polyarticular JIA or polyarticular course JIA, per International League of Associations for Rheumatology (ILAR) criteria.
Subject is judged to be in generally good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination performed at Screening and confirmed at Baseline. This includes, but is not limited to, a normal cardiopulmonary and normal neurological exam result.
Parent or legal guardian must be able and willing to administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
Parent or legal guardian must be willing to actively supervise storage and administration of study drug and to ensure that the time of each dose is accurately recorded in the subject's diary.
Subject must have negative purified protein derivative (PPD) test (or equivalent) at Screening. If subject has a positive (greater than or equal to 5mm induration) PPD test result, a chest x-ray (posterior-anterior [PA] and lateral view) must be performed. If subject has a positive test (or equivalent), has had a past ulcerative reaction to PPD placement, and/or a chest x ray consistent with tuberculosis [TB] exposure, subject may not be enrolled into the study.
For subjects in the European Union [EU], subject must have previously failed, had an insufficient response, or have been intolerant to at least one Disease-Modifying Anti Rheumatic Drug (DMARD).

Who cannot join

Subject has had prior exposure to Tysabri® (natalizumab) or Raptiva® (efalizumab) or any other biologic therapy, such as Orencia® (abatacept), Kineret® (anakinra), Actemra® (tocilizumab), Rituxan® (rituximab). Any previous use of anti-tumor necrosis factor [TNF] agents, including Enbrel® (etanercept), Remicade® (infliximab), Cimzia® (certolizumab pegol), Simponi® (golimumab), and adalimumab is also prohibited.
Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit.
Subject has undergone joint surgery within the preceding two months of the Screening Visit (at joints to be assessed within the study).
Subject has a previous diagnosis of a condition that could cause arthritis other than polyarticular JIA.
Subject has a history of an allergic reaction or significant sensitivity to constituents of the study drug, adalimumab.
Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half lives (whichever is longer) of the drug prior to Baseline visit. Should these biologics become approved, they would continue to be excluded.

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Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, recent cerebrovascular accidents, seizure disorder, and any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the study.
Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia, a clotting disorder), renal, liver disease (e.g., fibrosis, cirrhosis, hepatitis), or active gastroenteric ulcer.
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Subject has evidence of active TB infection.
Subject has history of moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), recent cerebrovascular accident or thrombotic event and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
Evidence of dysplasia or history of malignancy (including lymphoma and leukemia).
History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of central nervous system [CNS] demyelinating disease.
History of invasive fungal infection (e.g., listeriosis, histoplasmosis), active viral disorders, human immunodeficiency virus (HIV) infection.
Positive Hepatitis B test result.
Chronic recurring infections or active TB.
Screening laboratory and other analyses show any of the following abnormal results:
electrocardiogram [ECG] - with clinically significant abnormalities;
Aspartate transaminases (AST) or alanine transaminase (ALT) > 1.75 the upper limit of the reference range;
Total bilirubin >=3 mg/dL;
Serum creatinine > 1.6 mg/dL (convert to mmol/L).
Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma.

About this study

Official title: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg With Active Juvenile Idiopathic Arthritis (JIA)

Conditions: Juvenile Idiopathic Arthritis
Being tested: Adalimumab
Keywords: juvenile idiopathic arthritis, compassionate use, open label
Medical subject headings: Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AdalimumabDrug
Also called Humira, ABT-D2E7
Adalimumab solution for injection for subcutaneous use.

Study groups in NCT00775437
Study group	Role	What they receive
Adalimumab	Experimental	Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study. Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).
Measured: TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).

Secondary outcomes (46)

Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24
Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.
Measured: Weeks 0, 12, and 24
Hemoglobin: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Hematocrit: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Platelets: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Neutrophils: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Lymphocytes: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Monocytes: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Eosinophils: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Basophils: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug.Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Creatine Phosphokinase: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Total Bilirubin: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Creatinine: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Uric Acid: Mean Change From Baseline to Each Visit
Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30)
The PedACR30 response is defined by the PedACR as ≥30% improvement in at least 3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion [LOM] and joints with pain on passive motion [POM], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50)
The PedACR50 response is defined by the PedACR as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70)
The PedACR70 response is defined by the PedACR as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90)
The PedACR90 response is defined by the PedACR as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit
The physician's assessment of participant's overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit
The parent's assessment of how the participant's arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit
The DICHAQ is a self-reported participant-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A participant must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit
A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit
Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present ("1"), absent ("0"), or replaced/injected ("9"). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit
CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit
Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present ("1"), absent ("0") or replaced/injected ("9"). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit
Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present ("1"), absent ("0") or replaced/injected ("9"). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit
Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present ("1"), absent ("0"), or replaced/injected ("9"). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit
The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.
Measured: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Mar 2013

First posted20 Oct 2008 (estimated)
Study startMar 2009
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00775437
Sponsor's protocol ID: M10-444
Other IDs: 2009-013091-40, 2009
Status last verified: Dec 2015
First submitted: 17 Oct 2008
Last updated: 26 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.
PubMed 30054164
Kingsbury DJ, Bader-Meunier B, Patel G, Arora V, Kalabic J, Kupper H. Safety, effectiveness, and pharmacokinetics of adalimumab in children with polyarticular juvenile idiopathic arthritis aged 2 to 4 years. Clin Rheumatol. 2014;33(10):1433-41. doi: 10.1007/s10067-014-2498-1. Epub 2014 Feb 2.
PubMed 24487484

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Recruiting
The Use of Infrared Cameras for Detecting Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis, Infrared Thermography
Not yet recruitingPhase 4
Withdrawal Versus Continued TNF Inhibitor Monotherapy Treatment in Children With Inactive Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingObservational study
Tofacitinib in Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingPhase 3
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis

All Juvenile Idiopathic Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg With Active Juvenile Idiopathic Arthritis (JIA)
ClinicalTrials.gov ID: NCT00775437
Acronym / sponsor ID: M10-444
Conditions: Juvenile Idiopathic Arthritis
Keywords: juvenile idiopathic arthritis, compassionate use, open label
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 20 Oct 2008 (estimated)
Results: Posted 26 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adalimumab	Experimental	Drug: AdalimumabAdalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.

Who may qualify

Ages: 2 to 4 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

A parent or guardian has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject's parent or legal guardian has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed or before any medication is discontinued for the purpose of this study. The parent must also be willing to comply with all the requirements of this study protocol.
Subject has a disease diagnosis of moderately to severely active polyarticular or polyarticular course juvenile idiopathic arthritis (JIA; defined as arthritis affecting > = 5 joints at the time of treatment initiation). This corresponds to the International League of Associations for Rheumatology categories of polyarticular rheumatoid factor positive (RF+), polyarticular Rheumatoid factor negative (RF-) disease, and extended oligoarthritis disease.
Subject must be aged 2 to < 4 years old with moderately to severely active polyarticular JIA or polyarticular course JIA or age 4 or greater weighing < 15 kg with moderately to severely active polyarticular JIA or polyarticular course JIA, per International League of Associations for Rheumatology (ILAR) criteria.
Subject is judged to be in generally good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination performed at Screening and confirmed at Baseline. This includes, but is not limited to, a normal cardiopulmonary and normal neurological exam result.
Parent or legal guardian must be able and willing to administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.

Key exclusion criteria (22 listed)

Subject has had prior exposure to Tysabri® (natalizumab) or Raptiva® (efalizumab) or any other biologic therapy, such as Orencia® (abatacept), Kineret® (anakinra), Actemra® (tocilizumab), Rituxan® (rituximab). Any previous use of anti-tumor necrosis factor [TNF] agents, including Enbrel® (etanercept), Remicade® (infliximab), Cimzia® (certolizumab pegol), Simponi® (golimumab), and adalimumab is also prohibited.
Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit.
Subject has undergone joint surgery within the preceding two months of the Screening Visit (at joints to be assessed within the study).
Subject has a previous diagnosis of a condition that could cause arthritis other than polyarticular JIA.
Subject has a history of an allergic reaction or significant sensitivity to constituents of the study drug, adalimumab.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AdalimumabAlso: Humira, ABT-D2E7Adalimumab solution for injection for subcutaneous use.	Drug	Adalimumab

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).

46 secondary outcomes

Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24
Time frame: Weeks 0, 12, and 24
Hemoglobin: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Hematocrit: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Platelets: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Neutrophils: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Lymphocytes: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Monocytes: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Eosinophils: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Basophils: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Creatine Phosphokinase: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Total Bilirubin: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Creatinine: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Uric Acid: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30)
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50)
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70)
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90)
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
C-reactive Protein (CRP): Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations - Physical Category: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Results and safety

Results posted to the registry on 26 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab	32	26

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Measure	Adalimumab n = 32
Any Treatment-emergent AE	29
Any Treatment-emergent SAE	5

46 secondary outcomes are reported in the full results.

Adverse events

Time frame: TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab	5 of 32 (15.6%)	27 of 32 (84.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30054164Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.
Derived from this study: PubMed 24487484Kingsbury DJ, Bader-Meunier B, Patel G, Arora V, Kalabic J, Kupper H. Safety, effectiveness, and pharmacokinetics of adalimumab in children with polyarticular juvenile idiopathic arthritis aged 2 to 4 years. Clin Rheumatol. 2014;33(10):1433-41. doi: 10.1007/s10067-014-2498-1. Epub 2014 Feb 2.
Related InfoLink provided by the sponsor.

Related trials for Juvenile Idiopathic Arthritis

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A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aileen L. Pangan, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab in people with Juvenile Idiopathic Arthritis, run by AbbVie (prior sponsor, Abbott).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00775437, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.