Arthritis, Juvenile RheumatoidNCT01412021

Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

An observational study of Arthritis, Juvenile Rheumatoid, run by AbbVie.

Completed

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

Trial summary

This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug: Unknown adverse drug reactions (especially important adverse drug reactions) Incidence and conditions of occurrence of adverse reactions in the… Read more about this study

Who is it for?: Ages Up to 99 years
Conditions the study is for: Arthritis, Juvenile Rheumatoid
How many people: 375 participants
Where: No sites listed yet
Study dates: 1 Jul 2011to 2 Apr 2018
Phase: Observational
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 Up to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All patients who receive Humira for the treatment of Juvenile idiopathic arthritis

Who may be able to join

All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Who cannot join

Contraindications according to the Package Insert
Patients who have serious infections
Patients who have tuberculosis
Patients with a history of hypersensitivity to any ingredient of Humira
Patients who have demyelinating disease or with a history of demyelinating disease
Patients who have congestive cardiac failure

About this study

Official title: Humira® for Subcutaneous Injection Special Investigation ( All-case Survey ) in Patients With Juvenile Idiopathic Arthritis Study

This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug:

Unknown adverse drug reactions (especially important adverse drug reactions)
Incidence and conditions of occurrence of adverse reactions in the clinical setting
Factors that may affect the safety and effectiveness of Humira

Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Arthritis, Juvenile Rheumatoid
Medical subject headings: Arthritis, Juvenile

What participants receive

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

Study groups in NCT01412021
Study group	Role	What they receive
Humira		Participants with juvenile idiopathic arthritis who received Humira (adalimumab).

What is being measured

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

Change From Baseline in DAS28-4/ESR at Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 4
Change From Baseline in DAS28-4/ESR at Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 8
Change From Baseline in DAS28-4/ESR at Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 12
Change From Baseline in DAS28-4/ESR at Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 16
Change From Baseline in DAS28-4/ESR at Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 24
Change From Baseline in DAS28-4/CRP at Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 4
Change From Baseline in DAS28-4/CRP at Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 8
Change From Baseline in DAS28-4/CRP at Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 12
Change From Baseline in DAS28-4/CRP at Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 16
Change From Baseline in DAS28-4/CRP at Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Measured: Baseline, Week 24
Change From Baseline in Serum MMP3 Level at Week 4
Measured: Baseline, Week 4
Change From Baseline in Serum MMP3 Level at Week 8
Measured: Baseline, Week 8
Change From Baseline in Serum MMP3 Level at Week 12
Measured: Baseline, Week 12
Change From Baseline in Serum MMP3 Level at Week 16
Measured: Baseline, Week 16
Change From Baseline in Serum MMP3 Level at Week 24
Measured: Baseline, Week 24
Change From Baseline in Physician Global Assessment (VAS) at Week 4
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 4
Change From Baseline in Physician Global Assessment (VAS) at Week 8
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 8
Change From Baseline in Physician Global Assessment (VAS) at Week 12
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Change From Baseline in Physician Global Assessment (VAS) at Week 16
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 16
Change From Baseline in Physician Global Assessment (VAS) at Week 24
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Measured: Baseline, Week 24
Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24
Measured: Baseline, Week 24
Change From Baseline in Height at Week 4
Measured: Baseline, Week 4
Change From Baseline in Height at Week 8
Measured: Baseline, Week 8
Change From Baseline in Height at Week 12
Measured: Baseline, Week 12
Change From Baseline in Height at Week 16
Measured: Baseline, Week 16
Change From Baseline in Height at Week 24
Measured: Baseline, Week 24
Change From Baseline in Weight at Week 4
Measured: Baseline, Week 4
Change From Baseline in Weight at Week 8
Measured: Baseline, Week 8
Change From Baseline in Weight at Week 12
Measured: Baseline, Week 12
Change From Baseline in Weight at Week 16
Measured: Baseline, Week 16
Change From Baseline in Weight at Week 24
Measured: Baseline, Week 24

Timeline

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

1 Jul 20112 Apr 2018

First posted8 Aug 2011 (estimated)
Study start1 Jul 2011
Primary completion2 Apr 2018
Study completion2 Apr 2018

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.
Other trials for Arthritis, Juvenile RheumatoidStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 375 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01412021
Sponsor's protocol ID: P12-769
Status last verified: Jan 2019
First submitted: 5 Aug 2011
Last updated: 8 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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

RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
RecruitingObservational study
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Rheumatic Joint Disease
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Not yet recruitingPhase 3
Continued Access to Deucravacitinib for Adult SLE/SjD and Pediatric PsO/PsA Study Completers
Systemic Lupus Erythematosus, Sjögren's Disease
Not yet recruitingObservational study
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
Pericarditis, Tako-TSUBO Cardiomyopathy

All Arthritis, Juvenile Rheumatoid trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Humira® for Subcutaneous Injection Special Investigation ( All-case Survey ) in Patients With Juvenile Idiopathic Arthritis Study
ClinicalTrials.gov ID: NCT01412021
Acronym / sponsor ID: P12-769
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Arthritis, Juvenile Rheumatoid
Study type: Observational
Recruitment status: Completed
Enrolment: 375 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 1 Jul 2011 (actual)
Primary completion: 2 Apr 2018 (actual)
Study completion: 2 Apr 2018 (actual)
First posted: 8 Aug 2011 (estimated)
Results: Posted 8 Aug 2019

Clinical summary

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

This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug:

Unknown adverse drug reactions (especially important adverse drug reactions)
Incidence and conditions of occurrence of adverse reactions in the clinical setting
Factors that may affect the safety and effectiveness of Humira

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Humira	–	–Participants with juvenile idiopathic arthritis who received Humira (adalimumab).

Who may qualify

Ages: Up to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patients who receive Humira for the treatment of Juvenile idiopathic arthritis

Key inclusion criteria (1 listed)

All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Key exclusion criteria (6 listed)

Contraindications according to the Package Insert
Patients who have serious infections
Patients who have tuberculosis
Patients with a history of hypersensitivity to any ingredient of Humira
Patients who have demyelinating disease or with a history of demyelinating disease

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

Primary outcome

Change From Baseline in DAS28-4/ESR at Week 4
Time frame: Baseline, Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 8
Time frame: Baseline, Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 12
Time frame: Baseline, Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 16
Time frame: Baseline, Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/ESR at Week 24
Time frame: Baseline, Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 4
Time frame: Baseline, Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 8
Time frame: Baseline, Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 12
Time frame: Baseline, Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 16
Time frame: Baseline, Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in DAS28-4/CRP at Week 24
Time frame: Baseline, Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Change From Baseline in Serum MMP3 Level at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Serum MMP3 Level at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Serum MMP3 Level at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Serum MMP3 Level at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Serum MMP3 Level at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Physician Global Assessment (VAS) at Week 4
Time frame: Baseline, Week 4
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 8
Time frame: Baseline, Week 8
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 12
Time frame: Baseline, Week 12
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 16
Time frame: Baseline, Week 16
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 24
Time frame: Baseline, Week 24
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Height at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Height at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Height at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Height at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Height at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Weight at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Weight at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Weight at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Weight at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Weight at Week 24
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 8 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Humira	375	356

Primary outcome: Change From Baseline in DAS28-4/ESR at Week 4

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: units on a scale

Measure	Humira n = 145
Value	-1.01 (1.08)

Humira: p < 0.0001, paired t-test

Population analysed: participants in the efficacy analysis set with an assessment

Primary outcome: Change From Baseline in DAS28-4/ESR at Week 8

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: units on a scale

Measure	Humira n = 123
Value	-1.39 (1.26)

Humira: p < 0.0001, paired t-test

Population analysed: participants in the efficacy analysis set with an assessment

Primary outcome: Change From Baseline in DAS28-4/ESR at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Humira n = 127
Value	-1.39 (1.28)

Humira: p < 0.0001, paired t-test

Population analysed: participants in the efficacy analysis set with an assessment

Primary outcome: Change From Baseline in DAS28-4/ESR at Week 16

Time frame: Baseline, Week 16. Mean (Standard Deviation). Unit: units on a scale

Measure	Humira n = 134
Value	-1.46 (1.40)

Humira: p < 0.0001, paired t-test

Population analysed: participants in the efficacy analysis set with an assessment

Adverse events

Time frame: up to Week 24. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Humira	17 of 356 (4.8%)	20 of 356 (5.6%)	0 of 356

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Package Insert InformationLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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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.

AbbVie Inc. study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Juvenile Rheumatoid, run by AbbVie.

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 1 inclusion and 6 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 8 Aug 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2019). 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?

Change From Baseline in DAS28-4/ESR at Week 4 (time frame: Baseline, Week 4). The study lists 31 primary outcomes in all. 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 NCT01412021.

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 8 Aug 2019.