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Active Polyarticular Juvenile Idiopathic ArthritisPhase 3NCT01844518

Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

A Phase 3 study testing Abatacept in people with Active Polyarticular Juvenile Idiopathic Arthritis, run by Bristol-Myers Squibb at 57 sites in 12 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA Read more about this study

Who is it for?
Ages 2 to 17 years
What is being tested?
Abatacept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
57 sitesin 12 countries
Study dates
30 Aug 2013to 1 Feb 2023
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening
  • Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population
  • Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion.

Who cannot join

  • Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded.
  • Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.
  • Subjects who have failed more than two TNFα antagonists or other biologic DMARDs

Trial locations and contacts

57 sites in 12 countries.

57 sites in 12 countries

United States12 sites

  • Local Institution - 0007

    Birmingham, Alabama, 35233-1711

  • Local Institution - 0009

    Chicago, Illinois, 60637

  • Local Institution - 0008

    Cincinnati, Ohio, 45229

  • Local Institution - 0011

    Hartford, Connecticut, 06106

  • Riley Hospital For Children

    Indianapolis, Indiana, 46202

  • University Of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Local Institution - 0001

    Kansas City, Missouri, 64108

  • Local Institution - 0003

    Little Rock, Arkansas, 72202

  • Local Institution - 0005

    Portland, Oregon, 97227

  • Local Institution - 0004

    Salt Lake City, Utah, 84132

  • Seattle Children'S Hospital

    Seattle, Washington, 98105

  • Local Institution - 0002

    The Bronx, New York, 10467

Other trials in United States

Argentina5 sites

  • Local Institution - 0030

    Buenos Aires, 1270

  • Local Institution - 0064

    CABA, 1427

  • Local Institution - 0031

    Córdoba, 5000

  • Local Institution - 0029

    Rosario, Santa Fe Province, 2000

  • Local Institution - 0028

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Brazil5 sites

  • Local Institution

    Curitiba, Paraná, 80250-060

  • Local Institution - 0038

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Local Institution - 0042

    São Paulo, 04038-031

  • Local Institution - 0040

    São Paulo, 05403-000

  • Local Institution - 0041

    São Paulo, 05403-000

Other trials in Brazil

France5 sites

  • Local Institution - 0018

    Bron, 69677

  • Local Institution - 0016

    Le Kremlin-Bicêtre, 94275

  • Local Institution - 0014

    Paris, 75743

  • Local Institution - 0017

    Poitiers, 86021

  • Local Institution - 0015

    Strasbourg, 67098

Other trials in France

Germany5 sites

  • Local Institution - 0044

    Bad Bramstedt, 24576

  • Local Institution - 0045

    Berlin, 13353

  • Local Institution - 0046

    Hamburg, 22081

  • Local Institution - 0048

    Heidelberg, 69120

  • Local Institution - 0047

    Sankt Augustin, 53757

Other trials in Germany

Mexico5 sites

  • Local Institution - 0060

    Guadalajara, Jalisco, 44620

  • Local Institution - 0058

    Mérida, Yucatán, 97133

  • Local Institution - 0059

    Mexico City, Mexico City, 06720

  • Local Institution - 0057

    Mexico City, Mexico City, 06726

  • Local Institution - 0056

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Italy4 sites

  • Local Institution - 0061

    Florence, 50139

  • Local Institution

    Genova, 16147

  • Local Institution - 0022

    Milan, 20122

  • Local Institution - 0062

    Naples, 80131

Other trials in Italy

Peru4 sites

  • Local Institution - 0027

    Lima, 11

  • Local Institution

    Lima, 11

  • Local Institution - 0025

    Lima, 27

  • Local Institution - 0026

    Lima, 5

Other trials in Peru

South Africa4 sites

  • Local Institution - 0033

    Cape Town, Western Cape, 7500

  • Local Institution - 0035

    Park West, Bloemfontein, Free State, 9301

  • Local Institution - 0032

    Pretoria, Gauteng, 0002

  • Local Institution - 0034

    Pretoria, Gauteng, 0084

Other trials in South Africa

Spain4 sites

  • Local Institution - 0050

    Barcelona, 08950

  • Local Institution - 0053

    Madrid, 28034

  • Local Institution - 0055

    Madrid, 28041

  • Local Institution - 0052

    Valencia, 46026

Other trials in Spain

Belgium3 sites

  • Local Institution - 0037

    Brussels, 1200

  • Local Institution - 0036

    Ghent, 9000

  • Local Institution - 0049

    Leuven, 3000

Other trials in Belgium

Russia1 site

  • Local Institution - 0068

    Tolyatti, 445039

Other trials in Russia

About this study

Official title: A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA

Being tested
Abatacept

What participants receive

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

  • AbataceptBiological

    Also called Orencia

Study groups in NCT01844518
Study groupRoleWhat they receive
Short and Long Terms: OrenciaExperimentalShort Term: Orencia 50 mg/mL, 87.5 mg/mL, 125 mg/mL pre-filled syringes subcutaneously (0.4 mL/0.7 mL/1.0 mL) weekly for 4 months Long term: Orencia 50 mg/mL, 87.5 mg/mL, 125 mg/mL pre-filled syringes subcutaneously (0.4 mL/0.7 mL/1.0 mL) weekly for 20 months
Receives: Biological: Abatacept

What is being measured

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

  1. Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17

    Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be >= 10 µg/mL.

    Measured: Day 113

Secondary outcomes (6)

  1. Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)

    ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables:

    1. number of active joints
    2. number of joints with limitation of motion (LOM)
    3. physician global assessment of disease activity
    4. parent global assessment of patient overall well-being
    5. functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ)
    6. C-reactive protein (CRP). In addition to the above condition, to be considered a responder participants cannot have ≥30% worsening in more than 1 of the 3 remaining JIA core set variables for which improvement was not observed.

    Measured: Day 113

  2. Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose

    Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL). Here 'n' number analyzed signifies participants who were evaluable for each time point.

    Measured: Days 57, 85 and 113

  3. Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort

    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.

    Measured: From first dose up to 56 days post last dose in the short-term period (initial 4-month treatment period)

  4. Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period

    An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose which results in death, is life threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.

    Measured: From first dose up to 56 days after last dose ( up to approximately 2 years)

  5. Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort

    Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the short term (ST) period (initial 4-month treatment period) or completed the ST study without continuing abatacept treatment.

    Measured: From first dose up to start of LT (for those continuing in long-term) or up to 168 days after the lost dose of study medication in the ST period (for those not entering in the long-term)

  6. Number of Participants With Positive Immunogenicity Response in the Cumulative Period

    Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the short term (ST) or long term (LT) period, elected not to enter the LT period, or completed both ST and LT periods.

    Measured: From first dose up to 6 months following treatment discontinuation (up to approximately 2 years)

Timeline

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

  1. First posted1 May 2013 (estimated)
  2. Study start30 Aug 2013
  3. Primary completion12 Mar 2015
  4. Study completion1 Feb 2023

Resources

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
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01844518
Sponsor's protocol ID
IM101-301
Other IDs
2012-003195-39
Status last verified
Jun 2023
First submitted
29 Apr 2013
Last updated
12 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ruperto N, Lovell DJ, Berman A, Anton J, Viola DO, Lauwerys B, Rama ME, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Ally M, Rubio-Perez N, Gervais E, Van Zyl R, Wong R, Askelson M, Martini A, Brunner HI; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Abatacept as Monotherapy and in Combination With Methotrexate in Patients With Juvenile Idiopathic Arthritis: Analysis of 2 Phase III Trials. J Rheumatol. 2023 Nov;50(11):1471-1480. doi: 10.3899/jrheum.2022-1320. Epub 2023 Jul 15.

    PubMed 37453737

  • Brunner HI, Tzaribachev N, Louw I, Calvo Penades I, Avila-Zapata F, Horneff G, Foeldvari I, Kingsbury DJ, Paz Gastanaga ME, Wouters C, Breedt J, Wong R, Askelson M, Zhuo J, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG) investigators. Long-Term Maintenance of Clinical Responses by Individual Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Abatacept. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2259-2266. doi: 10.1002/acr.25156. Epub 2023 Jun 22.

    PubMed 37221146

  • Ruperto N, Lovell DJ, Berman A, Avila-Zapata F, Horneff G, Alessio M, Becker ML, Belot A, Burgos-Vargas R, Gamir ML, Goldenstein-Schainberg C, Scheibel IM, Terreri MT, Zemel L, Zhuo J, Askelson M, Wong R, Martini A, Brunner HI; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two-Year Results From an International Phase III Study. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1804-1814. doi: 10.1002/acr.24989. Epub 2023 Jan 29.

    PubMed 36710243

  • Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis. J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 15.

    PubMed 33452173

  • Brunner HI, Tzaribachev N, Cornejo GV, Joos R, Gervais E, Cimaz R, Calvo Penades I, Cuttica R, Lutz T, Quartier P, Gandhi Y, Nys M, Wong R, Martini A, Lovell DJ, Ruperto N; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept. Pediatr Rheumatol Online J. 2020 Feb 22;18(1):19. doi: 10.1186/s12969-020-0410-x.

    PubMed 32087715

  • Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Berman A, Calvo Penades I, Anton J, Avila-Zapata F, Cuttica R, Horneff G, Foeldvari I, Keltsev V, Kingsbury DJ, Viola DO, Joos R, Lauwerys B, Paz Gastanaga ME, Rama ME, Wouters C, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Miraval T, Ally MMTM, Rubio-Perez N, Solau Gervais E, van Zyl R, Li X, Nys M, Wong R, Banerjee S, Lovell DJ, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis: Results From a Phase III Open-Label Study. Arthritis Rheumatol. 2018 Jul;70(7):1144-1154. doi: 10.1002/art.40466. Epub 2018 May 20.

    PubMed 29481737

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abatacept in people with Active Polyarticular Juvenile Idiopathic Arthritis, run by Bristol-Myers Squibb at 57 sites in 12 countries.

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 3 inclusion and 3 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Argentina, Brazil, France, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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 24 Mar 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?

Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 (time frame: Day 113). 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 NCT01844518, which also lists 6 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 12 Jul 2023.

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