Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00048542

Collaborator

(none)

171

Enrollment

Locations

Arms

Duration (Months)

5.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Juvenile Idiopathic	Biological: Double-Blind Adalimumab/Placebo + MTX Biological: Double-Blind Adalimumab/Placebo Drug: OLE BSA Adalimumab +/- MTX Drug: OLE FD Adalimumab +/- MTX	Phase 3

Detailed Description

The study design for this clinical trial was chosen to evaluate adalimumab in subjects who were either methotrexate (MTX)-naive or had been withdrawn from MTX at least 2 weeks prior to study drug administration (non-MTX stratum) or were inadequate responders to MTX and continued MTX treatment (MTX stratum). The study consisted of 4 phases: a 16-week Open-label Lead-in (OL LI), a 32-week Double-blind (DB) phase, an up to 136-week Open-label Extension Body Surface Area (OLE BSA) phase, and an up to 224-week OLE Fixed Dose (FD) phase. All subjects who met entry criteria were enrolled into one of the appropriate strata and received adalimumab (plus concomitant MTX in the MTX stratum) in the 16 week OL LI phase of the study. All subjects who responded to adalimumab during the OL LI phase were to be enrolled in the DB phase of the study and randomized to receive adalimumab (plus concomitant MTX in the MTX stratum) or placebo (plus concomitant MTX in the MTX stratum). Subjects in the DB phase received either adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose) or placebo subcutaneously (SC) administered every other week (eow). Adalimumab or placebo was administered for an additional 32 weeks or until flare of disease (based on PedACR30 response criteria = a worsening of 30% or more in 3 of the 6 response variables (Parent's global assessment of subject's overall well-being by visual analog scale [VAS], Physician's global assessment [PhGA] of subject's disease severity by VAS, number of active joints [joints with swelling not due to deformity or joints with limitation of passive motion (LOM)], pain, tenderness, or both, number of joints with LOM, Childhood Health Assessment Questionnaire [CHAQ], and CRP levels), a minimum of 2 active joints, and no more than 1 indicator improving by 30% or more), whichever occurred earlier. For subjects who did not have a disease flare, the DB phase was completed at Week 48. Subjects who experienced disease flare during the DB phase or subjects who completed 48 weeks of the study were given the option to receive adalimumab for up to a minimum of 44 weeks (up to a maximum of 136 weeks) in the OLE BSA phase before being eligible to switch to the OLE FD phase. In this phase, subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose SC eow). All subjects who completed at least 44 weeks of OLE BSA treatment were given the opportunity to continue into the OLE FD phase for up to 224 weeks of additional adalimumab exposure. In this phase, subjects weighing less than 30 kg were treated with a fixed dose of 20 mg of adalimumab SC eow. Subjects weighing 30 kg or more were treated with a fixed dose of 40 mg of adalimumab SC eow.

Study Design

Study Type:

Interventional

Actual Enrollment :

171 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Double-Blind Adalimumab + MTX Subjects who were inadequate responders to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase received adalimumab plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Biological: Double-Blind Adalimumab/Placebo + MTX Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg. Other Names: ABT-D2E7 Humira
Placebo Comparator: Double-Blind Placebo + MTX Subjects who were inadequate responders to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase received placebo plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Biological: Double-Blind Adalimumab/Placebo + MTX Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg. Other Names: ABT-D2E7 Humira
Experimental: Double-Blind Adalimumab Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab, but no concomitant MTX treatment, during the Double-Blind Phase.	Biological: Double-Blind Adalimumab/Placebo Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) without MTX treatment for 32 weeks during the Double-Blind Phase. Total body dose of adalimumab was not to exceed 40 mg. Other Names: ABT-D2E7 Humira
Placebo Comparator: Double-Blind Placebo Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo, but no concomitant MTX treatment, during the Double-Blind Phase.	Biological: Double-Blind Adalimumab/Placebo Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) without MTX treatment for 32 weeks during the Double-Blind Phase. Total body dose of adalimumab was not to exceed 40 mg. Other Names: ABT-D2E7 Humira
Experimental: OLE BSA Adalimumab + MTX All subjects received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow), concomitantly with MTX treatment, during the Open-Label Extension (OLE) BSA Phase of the study.	Drug: OLE BSA Adalimumab +/- MTX Comparison of subcutaneous injection of 24 mg adalimumab per square meter of body surface area (BSA) every other week (eow) either with or without concomitant MTX treatment for a minimum of 44 weeks (up to a maximum of 136 weeks) during the Open-Label Extension BSA Phase. Other Names: ABT-D2E7 Humira
Experimental: OLE BSA Adalimumab All subjects received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow), but not MTX treatment, during the Open-Label Extension (OLE) BSA Phase of the study.	Drug: OLE BSA Adalimumab +/- MTX Comparison of subcutaneous injection of 24 mg adalimumab per square meter of body surface area (BSA) every other week (eow) either with or without concomitant MTX treatment for a minimum of 44 weeks (up to a maximum of 136 weeks) during the Open-Label Extension BSA Phase. Other Names: ABT-D2E7 Humira
Experimental: OLE FD Adalimumab + MTX Subjects received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Drug: OLE FD Adalimumab +/- MTX Comparison of adalimumab administered subcutaneously every other week (eow) either with or without concomitant MTX treatment for up to 224 weeks during the Open-Label Extension Fixed Dose (FD) Phase. Other Names: ABT-D2E7 Humira
Experimental: OLE FD Adalimumab Subjects received placebo without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Drug: OLE FD Adalimumab +/- MTX Comparison of adalimumab administered subcutaneously every other week (eow) either with or without concomitant MTX treatment for up to 224 weeks during the Open-Label Extension Fixed Dose (FD) Phase. Other Names: ABT-D2E7 Humira

Outcome Measures

Primary Outcome Measures

Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase [Week 16 to Week 48 (32 weeks)]
The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) >= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) >= 30% improvement in not more than 1 of the 6 JRA core set criteria.

Secondary Outcome Measures

Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase [Week 16]
Responders met the following criteria: >= 30% improvement in >= 3 of 6 JRA core set criteria, and >= 30% worsening in not more than 1 JRA criterion, compared with the open-label baseline. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.
Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase [Week 16 to Week 48 (32 Weeks)]
Subjects met criteria for disease flare if they had >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum [Week 16 to Week 48 (32 weeks)]
A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum [Week 16 to Week 48 (32 weeks)]
A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.
Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase [Week 48]
Responders met the following criteria: >= 30% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core criteria are included in PedACR criteria.
Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase [Week 48]
Responders met the following criteria: >= 50% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.
Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase [Week 48]
Responders met the following criteria: >= 70% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.
Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase [Baseline and Week 48]
A 100 mm horizontal visual analog scale (VAS) was used to assess the Physician Global Assessment of Disease Activity. The left end of the VAS scale (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.
Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase [Baseline and Week 48]
A 100 mm horizontal visual analog scale (VAS) was used to assess the Parent's/Patient's Global Assessment of Disease Activity. The left end of the VAS (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.
Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase [Baseline and Week 48]
Serum levels of C-reactive protein (CRP) were measured at screening (open-label baseline) and at Week 48. Negative mean changes in CRP from open-label baseline to Week 48 indicated improvement.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase [Open-Label Lead-In Phase Baseline]
Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase [Week 56]
Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase [Week 104]
Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase [Baseline]
Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase [Week 48]
Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase [Week 112]
Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase [Final Visit (up to 224 weeks of OLE FD phase)]
Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. Final Visit = last visit per subject (up to 224 weeks).

Other Outcome Measures

Baseline Measure: Gender, Female/Male - OLE BSA Phase [Baseline OLE BSA Phase]
Gender (female/male) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.
Baseline Measure: Age Continuous - OLE BSA Phase [Baseline OLE BSA Phase]
Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.
Baseline Measure: Gender, Female/Male - OLE FD Phase [Baseline OLE FD Phase]
Gender (female/male) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.
Baseline Measure: Age Continuous - OLE FD Phase [Baseline OLE FD Phase]
Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects must have a diagnosis of polyarticular juvenile idiopathic arthritis (JIA) age 4 to 17 by the American College of Rheumatology (ACR) criteria. Disease onset may have been systemic, polyarticular, or pauciarticular. If the disease was systemic onset, then the subjects must be free of any systemic JIA manifestations for at least 3 months before the time of qualification.
At the time of study screening, the subject must have continuing active disease defined as >= 5 swollen joints and >= 3 joints with limitation of motion (LOM). These joints are not mutually exclusive.
Subjects may be either naïve to MTX, inadequate responders to MTX, or intolerant to MTX. Intolerance to MTX will be defined by the subject's physician. The MTX must be maintained at a dose of at least 10 mg/m2 body surface area/week for a minimum of 3 months, prior to screening.
Duration of disease is not limited, but must have been long enough for a subject to have been given an adequate trial of nonsteroidal anti-inflammatory drugs (NSAIDs).
Have not received other disease-modifying anti-rheumatic drugs (DMARDs) including penicillamine, hydroxychloroquine, sulfasalazine, oral or injectable gold, cyclosporin; or intravenous immunoglobulin (IV Ig); or cytotoxic agents, for at least 4 weeks prior to receiving 1st dose of study drug. Subjects currently on one or more of these DMARDs must demonstrate active disease (defined above) prior to a minimum 4 weeks (28 days) washout of all DMARDs.
Subjects who are refractory to MTX after 3 months of treatment must demonstrate active disease (defined above) prior to enrollment in the open-label part of the trial.
Have not received an intra-articular glucocorticoid injection within 4 weeks (28 days) prior to enrollment into the study.
Have good venous access and stable hematocrit >= 24%.
All sexually active male and female study participants must be practicing adequate contraception. Post-pubertal females must have a negative serum pregnancy test no greater than 10 days prior to the first dose of study drug.
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.

Exclusion Criteria:

Pregnant or nursing female.
Functional class IV by ACR criteria.
Laboratory parameters outside limits established in the protocol.
Medical history, medical condition, or previous treatment not allowed by the protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Ref # / Investigator 45524	Birmingham	Alabama	United States	35294-3300
2	Site Reference ID/Investigator# 2235	Los Angeles	California	United States	90027
3	Site Reference ID/Investigator# 642	Stanford	California	United States	94305
4	Site Reference ID/Investigator# 638	Delray Beach	Florida	United States	33406
5	Site Ref # / Investigator 45543	St. Petersburg	Florida	United States	33701
6	Site Reference ID/Investigator# 640	Chicago	Illinois	United States	60649
7	Site Reference ID/Investigator# 644	Kansas City	Kansas	United States	66160
8	Site Reference ID/Investigator# 641	Minneapolis	Minnesota	United States	55455
9	Site Reference ID/Investigator# 645	Omaha	Nebraska	United States	68131
10	Site Reference ID/Investigator# 2501	Livingston	New Jersey	United States	07039
11	Site Ref # / Investigator 45542	New Hyde Park	New York	United States	11040
12	Site Ref # / Investigator 45544	Chapel Hill	North Carolina	United States	27599-7220
13	Site Reference ID/Investigator# 386	Columbus	Ohio	United States	43205
14	Site Ref # / Investigator 45525	Salt Lake City	Utah	United States	84312-2206
15	Site Reference ID/Investigator# 406	Norfolk	Virginia	United States	23507
16	Site Reference ID/Investigator# 621	Ghent		Belgium	9000
17	Site Reference ID/Investigator# 2538	Leuven		Belgium	3000
18	Site Reference ID/Investigator# 518	Prague 2		Czech Republic	128 50
19	Site Reference ID/Investigator# 519	Prague		Czech Republic	120 00
20	Site Reference ID/Investigator# 45545	Marseille Cedex 20		France	13915
21	Site Reference ID/Investigator# 516	Paris		France	75015
22	Site Reference ID/Investigator# 627	Berlin		Germany	13353
23	Site Reference ID/Investigator# 625	Bremen		Germany	D-28205
24	Site Ref # / Investigator 45522	Garmisch-Partenkirchen		Germany	82467
25	Site Reference ID/Investigator# 628	Halle (Saale)		Germany	D-06120
26	Site Reference ID/Investigator# 622	Hamburg		Germany	22081
27	Site Reference ID/Investigator# 631	Genoa		Italy	16147
28	Site Reference ID/Investigator# 636	Milano		Italy	20122
29	Site Ref # / Investigator 45523	Kosice		Slovakia	004001
30	Site Reference ID/Investigator# 3425	Piestany		Slovakia	921 01
31	Site Reference ID/Investigator# 3713	Madrid		Spain	28034

Sponsors and Collaborators

Abbott

Investigators

Study Director: Laura Redden, M.D., Ph.D., Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott

ClinicalTrials.gov Identifier:

NCT00048542

Other Study ID Numbers:

DE038

First Posted:

Nov 5, 2002

Last Update Posted:

Aug 22, 2011

Last Verified:

Aug 1, 2011

Keywords provided by Abbott

Polyarticular Juvenile Idiopathic Arthritis

Additional relevant MeSH terms:

Arthritis

Arthritis, Juvenile

Adalimumab

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled at 31 sites between 19 September 2002 and 13 January 2005.
Pre-assignment Detail	A total of 171 participants entered the Open-Label Lead-In (OL-LI) phase and received adalimumab. Of these 171 participants, 160 participants completed the OL-LI phase, and 133 participants entered the 32-week Double-Blind Phase (75 in the MTX stratum; 58 in the non-MTX stratum) and were randomized to adalimumab or placebo.

Arm/Group Title	Double-Blind Adalimumab + MTX	Double-Blind Placebo + MTX	Double-Blind Adalimumab	Double-Blind Placebo	Open-Label Extension BSA Adalimumab + MTX	Open-Label Extension BSA Adalimumab	Open-Label Extension FD Adalimumab + MTX	Open-Label Extension FD Adalimumab
Arm/Group Description	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.	Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.	Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Period Title: Double-Blind Phase
STARTED	38	37	30	28	0	0	0	0
COMPLETED	35	36	29	28	0	0	0	0
NOT COMPLETED	3	1	1	0	0	0	0	0
Period Title: Double-Blind Phase
STARTED	0	0	0	0	71	57	0	0
COMPLETED	0	0	0	0	59	47	0	0
NOT COMPLETED	0	0	0	0	12	10	0	0
Period Title: Double-Blind Phase
STARTED	0	0	0	0	0	0	59	47
COMPLETED	0	0	0	0	0	0	37	25
NOT COMPLETED	0	0	0	0	0	0	22	22

Baseline Characteristics

Arm/Group Title	Double-Blind Adalimumab + MTX	Double-Blind Placebo + MTX	Double-Blind Adalimumab	Double-Blind Placebo	Total
Arm/Group Description	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Total of all reporting groups
Overall Participants	38	37	30	28	133
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.7 (3.29)	10.8 (3.36)	11.1 (4.13)	11.3 (3.77)	11.2 (3.64)
Sex: Female, Male (Count of Participants)
Female	30 78.9%	30 81.1%	23 76.7%	20 71.4%	103 77.4%
Male	8 21.1%	7 18.9%	7 23.3%	8 28.6%	30 22.6%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase
Description	The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) >= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) >= 30% improvement in not more than 1 of the 6 JRA core set criteria.
Time Frame	Week 16 to Week 48 (32 weeks)

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum. Missing values were treated as disease flare.

Arm/Group Title	Double-Blind Adalimumab	Double-Blind Placebo
Arm/Group Description	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Measure Participants	30	28
Number [Participants]	13 34.2%	20 54.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Double-Blind Adalimumab, Double-Blind Placebo
	Comments	The study was sized to detect a difference in the proportion of subjects (40%) between placebo and the active adalimumab dose group who would experience disease flare assuming a placebo rate of 70% vs. a rate of 30% in the active group. Assuming a binomial distribution, an alpha of 0.05, 80% power, two-sided test, and an initial monotherapy responder rate of 70%, a minimum of 29 subjects were needed per treatment group within the appropriate strata.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.031
	Comments
	Method	Chi-square test
	Comments

2. Secondary Outcome

Title	Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase
Description	Responders met the following criteria: >= 30% improvement in >= 3 of 6 JRA core set criteria, and >= 30% worsening in not more than 1 JRA criterion, compared with the open-label baseline. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.

Arm/Group Title	Adalimumab + MTX	Adalimumab
Arm/Group Description	Subjects received methotrexate (MTX) plus open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]) during the Open-Label Lead-In (OL-LI) Phase of the study.	Subjects received open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]), but no methotrexate (MTX), during the Open-Label Lead-In (OL-LI) Phase of the study.
Measure Participants	85	86
Number [Participants]	80 210.5%	64 173%

3. Secondary Outcome

Title	Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase
Description	Subjects met criteria for disease flare if they had >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.
Time Frame	Week 16 to Week 48 (32 Weeks)

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum. Missing values were treated as disease flare.

Arm/Group Title	Double-Blind Adalimumab + MTX	Double-Blind Placebo + MTX
Arm/Group Description	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Measure Participants	38	37
Number [Participants]	14 36.8%	24 64.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Double-Blind Adalimumab, Double-Blind Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	Chi-square test
	Comments

4. Secondary Outcome

Title	Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum
Description	A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.
Time Frame	Week 16 to Week 48 (32 weeks)

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum.

Arm/Group Title	Double-Blind Adalimumab	Double-Blind Placebo
Arm/Group Description	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.	Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Measure Participants	30	28
Week 20	90.0 236.8%	78.6 212.4%
Week 24	83.3 219.2%	64.3 173.8%
Week 28	80.0 210.5%	60.7 164.1%
Week 32	70.0 184.2%	46.4 125.4%
Week 36	66.7 175.5%	46.4 125.4%
Week 40	60.0 157.9%	39.3 106.2%
Week 44	60.0 157.9%	32.1 86.8%
Week 48	56.7 149.2%	28.6 77.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Double-Blind Adalimumab, Double-Blind Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.029
	Comments
	Method	Log Rank
	Comments

5. Secondary Outcome

Title	Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum
Description	A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.
Time Frame	Week 16 to Week 48 (32 weeks)

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum.

Arm/Group Title	Double-Blind Adalimumab + MTX	Double-Blind Placebo + MTX
Arm/Group Description	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Measure Participants	38	37
Week 20	86.8 228.4%	83.8 226.5%
Week 24	78.9 207.6%	70.3 190%
Week 28	68.4 180%	59.5 160.8%
Week 32	68.4 180%	56.8 153.5%
Week 36	63.2 166.3%	48.6 131.4%
Week 40	63.2 166.3%	45.9 124.1%
Week 44	63.2 166.3%	43.2 116.8%
Week 48	63.2 166.3%	35.1 94.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Double-Blind Adalimumab, Double-Blind Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.031
	Comments
	Method	Log Rank
	Comments

6. Secondary Outcome

Title	Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase
Description	Responders met the following criteria: >= 30% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core criteria are included in PedACR criteria.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.

Arm/Group Title	Adalimumab	Placebo	Adalimumab + MTX	Placebo + MTX
Arm/Group Description	Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.	Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Measure Participants	30	28	38	37
Number [Participants]	17 44.7%	9 24.3%	24 80%	14 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Double-Blind Adalimumab, Double-Blind Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.061
	Comments
	Method	Pearson's Chi-square test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Adalimumab + MTX, Placebo + MTX
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	Pearson's Chi-square test
	Comments

7. Secondary Outcome

Title	Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase
Description	Responders met the following criteria: >= 50% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.

Arm/Group Title	Adalimumab	Placebo	Adalimumab + MTX	Placebo + MTX
Arm/Group Description	Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.	Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Measure Participants	30	28	38	37
Number [Participants]	16 42.1%	9 24.3%	24 80%	14 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Double-Blind Adalimumab, Double-Blind Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.103
	Comments
	Method	Pearson's Chi-square test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Adalimumab + MTX, Placebo + MTX
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	Pearson's Chi-square test
	Comments

8. Secondary Outcome

Title	Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase
Description	Responders met the following criteria: >= 70% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.

Arm/Group Title	Adalimumab	Placebo	Adalimumab + MTX	Placebo + MTX
Arm/Group Description	Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.	Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Measure Participants	30	28	38	37
Number [Participants]	14 36.8%	8 21.6%	24 80%	10 35.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Double-Blind Adalimumab, Double-Blind Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.156
	Comments
	Method	Pearson's Chi-square test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Adalimumab + MTX, Placebo + MTX
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Pearson's Chi-square test
	Comments

9. Secondary Outcome

Title	Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase
Description	A 100 mm horizontal visual analog scale (VAS) was used to assess the Physician Global Assessment of Disease Activity. The left end of the VAS scale (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.
Time Frame	Baseline and Week 48

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.

Arm/Group Title	Adalimumab	Placebo	Adalimumab + MTX	Placebo + MTX
Arm/Group Description	Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.	Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Measure Participants	17	9	24	15
Mean (Standard Error) [Units on a scale]	-52.06 (3.713)	-38.73 (6.554)	-48.50 (3.890)	-38.73 (6.554)

10. Secondary Outcome

Title	Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase
Description	A 100 mm horizontal visual analog scale (VAS) was used to assess the Parent's/Patient's Global Assessment of Disease Activity. The left end of the VAS (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.
Time Frame	Baseline and Week 48

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.

Arm/Group Title	Adalimumab	Placebo	Adalimumab + MTX	Placebo + MTX
Arm/Group Description	Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.	Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Measure Participants	17	9	24	15
Mean (Standard Error) [Units on a scale]	-41.53 (5.562)	-50.56 (6.129)	-36.42 (5.177)	-26.87 (5.644)

11. Secondary Outcome

Title	Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase
Description	Serum levels of C-reactive protein (CRP) were measured at screening (open-label baseline) and at Week 48. Negative mean changes in CRP from open-label baseline to Week 48 indicated improvement.
Time Frame	Baseline and Week 48

Outcome Measure Data

Analysis Population Description
All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.

Arm/Group Title	Adalimumab	Placebo	Adalimumab + MTX	Placebo + MTX
Arm/Group Description	Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.	Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.	Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Measure Participants	17	9	24	15
Mean (Standard Error) [mg/dL]	-1.79 (0.803)	-3.91 (2.000)	-1.71 (0.529)	-0.10 (0.333)

12. Secondary Outcome

Title	Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase
Description	Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Time Frame	Open-Label Lead-In Phase Baseline

Outcome Measure Data

Analysis Population Description
The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.

Arm/Group Title	OLE BSA Adalimumab + MTX	OLE BSA Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
Measure Participants	67	53
PedACR30 Baseline	55 144.7%	46 124.3%
PedACR50 Baseline	47 123.7%	41 110.8%
PedACR70 Baseline	35 92.1%	30 81.1%

13. Secondary Outcome

Title	Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase
Description	Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Time Frame	Week 56

Outcome Measure Data

Analysis Population Description
The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.

Arm/Group Title	OLE BSA Adalimumab + MTX	OLE BSA Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
Measure Participants	55	41
PedACR30 Week 56	50 131.6%	40 108.1%
PedACR50 Week 56	49 128.9%	40 108.1%
PedACR70 Week 56	43 113.2%	35 94.6%

14. Secondary Outcome

Title	Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase
Description	Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Time Frame	Week 104

Outcome Measure Data

Analysis Population Description
The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.

Arm/Group Title	OLE BSA Adalimumab + MTX	OLE BSA Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
Measure Participants	19	17
PedACR30 Week 104	18 47.4%	16 43.2%
PedACR50 Week 104	16 42.1%	16 43.2%
PedACR70 Week 104	14 36.8%	14 37.8%

15. Secondary Outcome

Title	Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase
Description	Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.

Arm/Group Title	OLE FD Adalimumab + MTX	OLE FD Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Measure Participants	53	45
PedACR30 OLE FD Baseline	53 139.5%	44 118.9%
PedACR50 OLE FD Baseline	50 131.6%	43 116.2%
PedACR70 OLE FD Baseline	46 121.1%	40 108.1%

16. Secondary Outcome

Title	Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase
Description	Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description
The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.

Arm/Group Title	OLE FD Adalimumab + MTX	OLE FD Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Measure Participants	51	40
PedACR30 Week 48	47 123.7%	40 108.1%
PedACR50 Week 48	47 123.7%	39 105.4%
PedACR70 Week 48	44 115.8%	38 102.7%

17. Secondary Outcome

Title	Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase
Description	Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.
Time Frame	Week 112

Outcome Measure Data

Analysis Population Description
The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.

Arm/Group Title	OLE FD Adalimumab + MTX	OLE FD Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Measure Participants	41	31
PedACR30 Week 112	39 102.6%	31 83.8%
PedACR50 Week 112	39 102.6%	30 81.1%
PedACR70 Week 112	34 89.5%	29 78.4%

18. Secondary Outcome

Title	Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase
Description	Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. Final Visit = last visit per subject (up to 224 weeks).
Time Frame	Final Visit (up to 224 weeks of OLE FD phase)

Outcome Measure Data

Analysis Population Description
The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.

Arm/Group Title	OLE FD Adalimumab + MTX	OLE FD Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Measure Participants	55	46
PedACR30 Final Visit	48 126.3%	44 118.9%
PedACR50 Final Visit	45 118.4%	43 116.2%
PedACR70 Final Visit	43 113.2%	40 108.1%

19. Other Pre-specified Outcome

Title	Baseline Measure: Gender, Female/Male - OLE BSA Phase
Description	Gender (female/male) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.
Time Frame	Baseline OLE BSA Phase

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	OLE BSA Adalimumab + MTX	OLE BSA Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
Measure Participants	71	57
OLE BSA Phase - Female	56 147.4%	42 113.5%
OLE BSA Phase - Male	15 39.5%	15 40.5%

20. Other Pre-specified Outcome

Title	Baseline Measure: Age Continuous - OLE BSA Phase
Description	Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.
Time Frame	Baseline OLE BSA Phase

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	OLE BSA Adalimumab + MTX	OLE BSA Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
Measure Participants	71	57
Mean (Standard Deviation) [Years]	11.3 (3.32)	11.2 (3.96)

21. Other Pre-specified Outcome

Title	Baseline Measure: Gender, Female/Male - OLE FD Phase
Description	Gender (female/male) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.
Time Frame	Baseline OLE FD Phase

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	OLE FD Adalimumab + MTX	OLE FD Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Measure Participants	59	47
OLE FD Phase - Female	45 118.4%	33 89.2%
OLE FD Phase - Male	14 36.8%	14 37.8%

22. Other Pre-specified Outcome

Title	Baseline Measure: Age Continuous - OLE FD Phase
Description	Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.
Time Frame	Baseline OLE FD Phase

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	OLE FD Adalimumab + MTX	OLE FD Adalimumab
Arm/Group Description	Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.	Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Measure Participants	59	47
Mean (Standard Deviation) [Years]	11.1 (3.36)	11.0 (4.12)

Adverse Events

	Double-Blind Adalimumab + MTX		Double-Blind Placebo + MTX		Double-Blind Adalimumab		Double-Blind Placebo		Open-Label Extension BSA Adalimumab + MTX		Open-Label Extension BSA Adalimumab		Open-Label Extension FD Adalimumab + MTX		Open-Label Extension FD Adalimumab
Time Frame	DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Adverse Event Reporting Description

Arm/Group Title	Double-Blind Adalimumab + MTX		Double-Blind Placebo + MTX		Double-Blind Adalimumab		Double-Blind Placebo		Open-Label Extension BSA Adalimumab + MTX		Open-Label Extension BSA Adalimumab		Open-Label Extension FD Adalimumab + MTX		Open-Label Extension FD Adalimumab
Arm/Group Description	Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.		Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.		Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.		Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.		Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.		Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.		Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.		Subjects in the methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Double-Blind Adalimumab + MTX		Double-Blind Placebo + MTX		Double-Blind Adalimumab		Double-Blind Placebo		Open-Label Extension BSA Adalimumab + MTX		Open-Label Extension BSA Adalimumab		Open-Label Extension FD Adalimumab + MTX		Open-Label Extension FD Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/38 (7.9%)		2/37 (5.4%)		1/30 (3.3%)		0/28 (0%)		13/71 (18.3%)		9/57 (15.8%)		7/59 (11.9%)		10/47 (21.3%)
Cardiac disorders
Pericarditis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Eye disorders
Retinal detachment	0/38 (0%)		1/37 (2.7%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Gastrointestinal disorders
Gastroduodenitis	0/38 (0%)		1/37 (2.7%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Vomiting	1/38 (2.6%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Abdominal pain	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Haematochezia	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Malabsorption	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		1/57 (1.8%)		0/59 (0%)		0/47 (0%)
Infections and infestations
Appendicitis	1/38 (2.6%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Urinary tract infection	0/38 (0%)		0/37 (0%)		1/30 (3.3%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Bronchopneumonia	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		1/57 (1.8%)		0/59 (0%)		0/47 (0%)
Herpes zoster	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		1/57 (1.8%)		0/59 (0%)		0/47 (0%)
Pharyngitis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Viral infection	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Cervicitis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		1/59 (1.7%)		0/47 (0%)
Injury, poisoning and procedural complications
Injury	1/38 (2.6%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Joint dislocation	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		1/57 (1.8%)		0/59 (0%)		0/47 (0%)
Investigations
Laboratory test abnormal	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		1/59 (1.7%)		0/47 (0%)
Metabolism and nutrition disorders
Diabetic ketoacidosis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		1/59 (1.7%)		0/47 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		2/71 (2.8%)		0/57 (0%)		4/59 (6.8%)		7/47 (14.9%)
Joint contracture	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		1/57 (1.8%)		0/59 (0%)		0/47 (0%)
Juvenile arthritis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		5/71 (7%)		1/57 (1.8%)		1/59 (1.7%)		1/47 (2.1%)
Osteoarthritis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Knee Deformity	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		1/59 (1.7%)		1/47 (2.1%)
Osteochondrosis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Rheumatoid arthritis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		1/59 (1.7%)		0/47 (0%)
Spondylolisthesis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Tendon disorder	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Tendonitis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		1/59 (1.7%)		0/47 (0%)
Nervous system disorders
Hydrocephalus	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Speech disorder	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		1/57 (1.8%)		0/59 (0%)		0/47 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		1/57 (1.8%)		0/59 (0%)		0/47 (0%)
Abortion spontaneous	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Psychiatric disorders
Bipolar disorder	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Psychotic disorder	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Reproductive system and breast disorders
Breast enlargement	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		2/57 (3.5%)		0/59 (0%)		0/47 (0%)
Nasal septum deviation	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		1/57 (1.8%)		0/59 (0%)		0/47 (0%)
Tonsillar hypertrophy	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		2/57 (3.5%)		0/59 (0%)		0/47 (0%)
Skin and subcutaneous tissue disorders
Acne	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		1/47 (2.1%)
Surgical and medical procedures
Abortion induced	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		1/59 (1.7%)		0/47 (0%)
Other (Not Including Serious) Adverse Events
	Double-Blind Adalimumab + MTX		Double-Blind Placebo + MTX		Double-Blind Adalimumab		Double-Blind Placebo		Open-Label Extension BSA Adalimumab + MTX		Open-Label Extension BSA Adalimumab		Open-Label Extension FD Adalimumab + MTX		Open-Label Extension FD Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/38 (71.1%)		19/37 (51.4%)		20/30 (66.7%)		20/28 (71.4%)		62/71 (87.3%)		46/57 (80.7%)		54/59 (91.5%)		37/47 (78.7%)
Ear and labyrinth disorders
Ear pain	0/38 (0%)		0/37 (0%)		3/30 (10%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Eye disorders
Conjunctivitis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		4/57 (7%)		0/59 (0%)		0/47 (0%)
Gastrointestinal disorders
Abdominal pain	0/38 (0%)		0/37 (0%)		0/30 (0%)		2/28 (7.1%)		0/71 (0%)		0/57 (0%)		5/59 (8.5%)		4/47 (8.5%)
Vomiting	3/38 (7.9%)		2/37 (5.4%)		0/30 (0%)		1/28 (3.6%)		5/71 (7%)		3/57 (5.3%)		2/59 (3.4%)		3/47 (6.4%)
Nausea	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		9/71 (12.7%)		3/57 (5.3%)		2/59 (3.4%)		6/47 (12.8%)
Abdominal pain upper	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		1/59 (1.7%)		4/47 (8.5%)
General disorders
Influenza like illness	0/38 (0%)		4/37 (10.8%)		0/30 (0%)		0/28 (0%)		4/71 (5.6%)		1/57 (1.8%)		0/59 (0%)		0/47 (0%)
Injection site burning	1/38 (2.6%)		2/37 (5.4%)		4/30 (13.3%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Injection site erythema	2/38 (5.3%)		1/37 (2.7%)		1/30 (3.3%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Injection site pain	7/38 (18.4%)		6/37 (16.2%)		5/30 (16.7%)		3/28 (10.7%)		14/71 (19.7%)		10/57 (17.5%)		4/59 (6.8%)		4/47 (8.5%)
Injection site reaction	7/38 (18.4%)		1/37 (2.7%)		3/30 (10%)		1/28 (3.6%)		8/71 (11.3%)		9/57 (15.8%)		0/59 (0%)		0/47 (0%)
Pain	1/38 (2.6%)		1/37 (2.7%)		3/30 (10%)		3/28 (10.7%)		0/71 (0%)		3/57 (5.3%)		0/59 (0%)		3/47 (6.4%)
Pyrexia	2/38 (5.3%)		0/37 (0%)		1/30 (3.3%)		1/28 (3.6%)		4/71 (5.6%)		6/57 (10.5%)		2/59 (3.4%)		5/47 (10.6%)
Fatigue	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		3/59 (5.1%)		0/47 (0%)
Immune system disorders
Hypersensitivity	2/38 (5.3%)		0/37 (0%)		2/30 (6.7%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		2/59 (3.4%)		3/47 (6.4%)
Infections and infestations
Acute tonsillitis	1/38 (2.6%)		2/37 (5.4%)		0/30 (0%)		0/28 (0%)		4/71 (5.6%)		0/57 (0%)		6/59 (10.2%)		0/47 (0%)
Herpes simplex	1/38 (2.6%)		2/37 (5.4%)		1/30 (3.3%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Impetigo	2/38 (5.3%)		0/37 (0%)		1/30 (3.3%)		0/28 (0%)		2/71 (2.8%)		5/57 (8.8%)		0/59 (0%)		0/47 (0%)
Influenza	1/38 (2.6%)		1/37 (2.7%)		0/30 (0%)		2/28 (7.1%)		2/71 (2.8%)		4/57 (7%)		3/59 (5.1%)		5/47 (10.6%)
Nasopharyngitis	5/38 (13.2%)		4/37 (10.8%)		0/30 (0%)		3/28 (10.7%)		9/71 (12.7%)		4/57 (7%)		7/59 (11.9%)		3/47 (6.4%)
Paronychia	1/38 (2.6%)		0/37 (0%)		2/30 (6.7%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Pharyngitis	1/38 (2.6%)		2/37 (5.4%)		0/30 (0%)		1/28 (3.6%)		9/71 (12.7%)		4/57 (7%)		6/59 (10.2%)		1/47 (2.1%)
Rhinitis	3/38 (7.9%)		0/37 (0%)		2/30 (6.7%)		0/28 (0%)		4/71 (5.6%)		2/57 (3.5%)		3/59 (5.1%)		4/47 (8.5%)
Sinusitis	2/38 (5.3%)		0/37 (0%)		0/30 (0%)		1/28 (3.6%)		7/71 (9.9%)		7/57 (12.3%)		7/59 (11.9%)		3/47 (6.4%)
Upper respiratory tract infection	5/38 (13.2%)		4/37 (10.8%)		6/30 (20%)		5/28 (17.9%)		21/71 (29.6%)		19/57 (33.3%)		15/59 (25.4%)		13/47 (27.7%)
Viral infection	6/38 (15.8%)		2/37 (5.4%)		6/30 (20%)		3/28 (10.7%)		13/71 (18.3%)		9/57 (15.8%)		15/59 (25.4%)		8/47 (17%)
Bronchitis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		4/71 (5.6%)		2/57 (3.5%)		0/59 (0%)		0/47 (0%)
Ear infection	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		4/71 (5.6%)		0/57 (0%)		7/59 (11.9%)		3/47 (6.4%)
Gastroenteritis viral	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		3/59 (5.1%)		1/47 (2.1%)
Otitis media	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		2/71 (2.8%)		5/57 (8.8%)		3/59 (5.1%)		1/47 (2.1%)
Pharyngitis streptococcal	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		3/71 (4.2%)		6/57 (10.5%)		1/59 (1.7%)		3/47 (6.4%)
Urinary tract infection	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		5/71 (7%)		4/57 (7%)		5/59 (8.5%)		2/47 (4.3%)
Viral upper respiratory tract infection	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		3/71 (4.2%)		4/57 (7%)		0/59 (0%)		0/47 (0%)
Oral herpes	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		3/59 (5.1%)		0/47 (0%)
Tonsillitis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		3/59 (5.1%)		2/47 (4.3%)
Injury, poisoning and procedural complications
Arthropod bite	1/38 (2.6%)		1/37 (2.7%)		0/30 (0%)		2/28 (7.1%)		4/71 (5.6%)		2/57 (3.5%)		0/59 (0%)		0/47 (0%)
Blister	2/38 (5.3%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Contusion	7/38 (18.4%)		5/37 (13.5%)		2/30 (6.7%)		2/28 (7.1%)		4/71 (5.6%)		3/57 (5.3%)		1/59 (1.7%)		4/47 (8.5%)
Excoriation	4/38 (10.5%)		1/37 (2.7%)		3/30 (10%)		1/28 (3.6%)		7/71 (9.9%)		4/57 (7%)		2/59 (3.4%)		4/47 (8.5%)
Injury	2/38 (5.3%)		1/37 (2.7%)		0/30 (0%)		3/28 (10.7%)		0/71 (0%)		0/57 (0%)		1/59 (1.7%)		4/47 (8.5%)
Joint sprain	2/38 (5.3%)		0/37 (0%)		0/30 (0%)		2/28 (7.1%)		1/71 (1.4%)		4/57 (7%)		0/59 (0%)		0/47 (0%)
Muscle strain	0/38 (0%)		1/37 (2.7%)		2/30 (6.7%)		1/28 (3.6%)		1/71 (1.4%)		4/57 (7%)		0/59 (0%)		0/47 (0%)
Skin laceration	2/38 (5.3%)		0/37 (0%)		1/30 (3.3%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Thermal burn	1/38 (2.6%)		3/37 (8.1%)		0/30 (0%)		1/28 (3.6%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Investigations
Blood triglycerides increased	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		3/59 (5.1%)		2/47 (4.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/38 (5.3%)		0/37 (0%)		2/30 (6.7%)		0/28 (0%)		5/71 (7%)		6/57 (10.5%)		4/59 (6.8%)		7/47 (14.9%)
Juvenile arthritis	2/38 (5.3%)		1/37 (2.7%)		0/30 (0%)		1/28 (3.6%)		2/71 (2.8%)		3/57 (5.3%)		4/59 (6.8%)		4/47 (8.5%)
Pain in extremity	0/38 (0%)		0/37 (0%)		0/30 (0%)		2/28 (7.1%)		4/71 (5.6%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Rheumatoid arthritis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		7/71 (9.9%)		7/57 (12.3%)		7/59 (11.9%)		6/47 (12.8%)
Muscle spasms	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		1/71 (1.4%)		3/57 (5.3%)		0/59 (0%)		0/47 (0%)
Synovitis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		3/47 (6.4%)
Arthritis	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		4/59 (6.8%)		7/47 (14.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	1/38 (2.6%)		0/37 (0%)		1/30 (3.3%)		2/28 (7.1%)		2/71 (2.8%)		3/57 (5.3%)		2/59 (3.4%)		3/47 (6.4%)
Nervous system disorders
Headache	2/38 (5.3%)		3/37 (8.1%)		2/30 (6.7%)		4/28 (14.3%)		9/71 (12.7%)		8/57 (14%)		4/59 (6.8%)		11/47 (23.4%)
Reproductive system and breast disorders
Dysmenorrhoea	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		2/71 (2.8%)		3/57 (5.3%)		3/59 (5.1%)		0/47 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	2/38 (5.3%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Cough	2/38 (5.3%)		0/37 (0%)		1/30 (3.3%)		1/28 (3.6%)		6/71 (8.5%)		5/57 (8.8%)		0/59 (0%)		0/47 (0%)
Oropharyngeal pain	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		6/71 (8.5%)		0/57 (0%)		4/59 (6.8%)		0/47 (0%)
Rhinitis allergic	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		3/59 (5.1%)		0/47 (0%)
Skin and subcutaneous tissue disorders
Acne	1/38 (2.6%)		0/37 (0%)		2/30 (6.7%)		1/28 (3.6%)		0/71 (0%)		0/57 (0%)		3/59 (5.1%)		2/47 (4.3%)
Ecchymosis	2/38 (5.3%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Erythema	0/38 (0%)		1/37 (2.7%)		0/30 (0%)		2/28 (7.1%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Pruritus	0/38 (0%)		0/37 (0%)		0/30 (0%)		2/28 (7.1%)		0/71 (0%)		0/57 (0%)		0/59 (0%)		0/47 (0%)
Rash	1/38 (2.6%)		1/37 (2.7%)		2/30 (6.7%)		0/28 (0%)		5/71 (7%)		4/57 (7%)		2/59 (3.4%)		6/47 (12.8%)
Dermatitis contact	0/38 (0%)		0/37 (0%)		0/30 (0%)		0/28 (0%)		5/71 (7%)		0/57 (0%)		3/59 (5.1%)		4/47 (8.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

Results Point of Contact

Name/Title	Global Medical Services
Organization	Abbott
Phone	800-633-9110
Email

Responsible Party:

Abbott

ClinicalTrials.gov Identifier:

NCT00048542

Other Study ID Numbers:

DE038

First Posted:

Nov 5, 2002

Last Update Posted:

Aug 22, 2011

Last Verified:

Aug 1, 2011

Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Other Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact