Study of Human Anti-TNF Monoclonal Antibody Adalimumab in... | NCT00048542 | Trialant
NCT00048542
Sponsor
Abbott
Status
Completed
Last Update Posted
Aug 22, 2011Estimated
Enrollment
171Actual
Phase
Phase 3
Conditions
Arthritis, Juvenile Idiopathic
Interventions
Double-Blind Adalimumab/Placebo + MTX
Double-Blind Adalimumab/Placebo
OLE BSA Adalimumab +/- MTX
OLE FD Adalimumab +/- MTX
Countries
United States
Belgium
Czechia
France
Germany
Italy
Slovakia
Spain
Protocol Section
Identification Module
NCT ID
NCT00048542
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DE038
Secondary IDs
Not provided
Brief Title
Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)
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
Acronym
Not provided
Organization
AbbottINDUSTRY
Status Module
Record Verification Date
Aug 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2002
Primary Completion Date
Jan 2005Actual
Completion Date
Jun 2010Actual
First Submitted Date
Nov 1, 2002
First Submission Date that Met QC Criteria
Nov 4, 2002
First Posted Date
Nov 5, 2002Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 7, 2009
Results First Submitted that Met QC Criteria
Dec 7, 2009
Results First Posted Date
Jan 11, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 18, 2011
Last Update Posted Date
Aug 22, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbottINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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.
Conditions Module
Conditions
Arthritis, Juvenile Idiopathic
Keywords
Polyarticular Juvenile Idiopathic Arthritis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
171Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Double-Blind Adalimumab + MTX
Experimental
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
Double-Blind Placebo + MTX
Placebo Comparator
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
Double-Blind Adalimumab
Experimental
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
Double-Blind Placebo
Placebo Comparator
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Double-Blind Adalimumab/Placebo + MTX
Biological
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase
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.
Week 16 to Week 48 (32 weeks)
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase
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.
Other Outcomes
Measure
Description
Time Frame
Baseline Measure: Gender, Female/Male - 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 OLE BSA Phase
Eligibility Module
Eligibility Criteria
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.
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.
Recruitment Details
Subjects were enrolled at 31 sites between 19 September 2002 and 13 January 2005.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Double-Blind Adalimumab + MTX
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.
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
OLE BSA Adalimumab
Experimental
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
OLE FD Adalimumab + MTX
Experimental
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
OLE FD Adalimumab
Experimental
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
Double-Blind Adalimumab + MTX
Double-Blind Placebo + MTX
ABT-D2E7
Humira
Double-Blind Adalimumab/Placebo
Biological
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.
Double-Blind Adalimumab
Double-Blind Placebo
ABT-D2E7
Humira
OLE BSA Adalimumab +/- MTX
Drug
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.
OLE BSA Adalimumab
OLE BSA Adalimumab + MTX
ABT-D2E7
Humira
OLE FD Adalimumab +/- MTX
Drug
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.
OLE FD Adalimumab
OLE FD Adalimumab + MTX
ABT-D2E7
Humira
Week 16
Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase
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.
Week 16 to Week 48 (32 Weeks)
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum
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.
Week 16 to Week 48 (32 weeks)
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum
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.
Week 16 to Week 48 (32 weeks)
Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase
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.
Week 48
Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase
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.
Week 48
Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase
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.
Week 48
Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase
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.
Baseline and Week 48
Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase
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.
Baseline and Week 48
Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase
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.
Baseline and Week 48
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area 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. All core assessments are included in PedACR criteria.
Open-Label Lead-In Phase Baseline
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area 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. All core assessments are included in PedACR criteria.
Week 56
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area 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. All core assessments are included in PedACR criteria.
Week 104
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose 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-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.
Baseline
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose 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-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.
Week 48
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose 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. All core assessments are included in PedACR criteria.
Week 112
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
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).
Final Visit (up to 224 weeks of OLE FD phase)
Baseline Measure: Age Continuous - 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 OLE BSA Phase
Baseline Measure: Gender, Female/Male - 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 OLE FD Phase
Baseline Measure: Age Continuous - 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.
Baseline OLE FD Phase
Los Angeles
California
90027
United States
Site Reference ID/Investigator# 642
Stanford
California
94305
United States
Site Reference ID/Investigator# 638
Delray Beach
Florida
33406
United States
Site Ref # / Investigator 45543
St. Petersburg
Florida
33701
United States
Site Reference ID/Investigator# 640
Chicago
Illinois
60649
United States
Site Reference ID/Investigator# 644
Kansas City
Kansas
66160
United States
Site Reference ID/Investigator# 641
Minneapolis
Minnesota
55455
United States
Site Reference ID/Investigator# 645
Omaha
Nebraska
68131
United States
Site Reference ID/Investigator# 2501
Livingston
New Jersey
07039
United States
Site Ref # / Investigator 45542
New Hyde Park
New York
11040
United States
Site Ref # / Investigator 45544
Chapel Hill
North Carolina
27599-7220
United States
Site Reference ID/Investigator# 386
Columbus
Ohio
43205
United States
Site Ref # / Investigator 45525
Salt Lake City
Utah
84312-2206
United States
Site Reference ID/Investigator# 406
Norfolk
Virginia
23507
United States
Site Reference ID/Investigator# 621
Ghent
9000
Belgium
Site Reference ID/Investigator# 2538
Leuven
3000
Belgium
Site Reference ID/Investigator# 519
Prague
120 00
Czechia
Site Reference ID/Investigator# 518
Prague
128 50
Czechia
Site Reference ID/Investigator# 45545
Marseille
13915
France
Site Reference ID/Investigator# 516
Paris
75015
France
Site Reference ID/Investigator# 627
Berlin
13353
Germany
Site Reference ID/Investigator# 625
Bremen
D-28205
Germany
Site Ref # / Investigator 45522
Garmisch-Partenkirchen
82467
Germany
Site Reference ID/Investigator# 628
Halle
D-06120
Germany
Site Reference ID/Investigator# 622
Hamburg
22081
Germany
Site Reference ID/Investigator# 631
Genoa
16147
Italy
Site Reference ID/Investigator# 636
Milan
20122
Italy
Site Ref # / Investigator 45523
Košice
004001
Slovakia
Site Reference ID/Investigator# 3425
Piešťany
921 01
Slovakia
Site Reference ID/Investigator# 3713
Madrid
28034
Spain
Derived
Lovell DJ, Ruperto N, Goodman S, Reiff A, Jung L, Jarosova K, Nemcova D, Mouy R, Sandborg C, Bohnsack J, Elewaut D, Foeldvari I, Gerloni V, Rovensky J, Minden K, Vehe RK, Weiner LW, Horneff G, Huppertz HI, Olson NY, Medich JR, Carcereri-De-Prati R, McIlraith MJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group; Pediatric Rheumatology International Trials Organisation. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008 Aug 21;359(8):810-20. doi: 10.1056/NEJMoa0706290.
FG001
Double-Blind Placebo + MTX
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.
FG002
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 (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.
FG003
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 (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.
FG004
Open-Label Extension BSA Adalimumab + MTX
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.
FG005
Open-Label Extension BSA Adalimumab
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.
FG006
Open-Label Extension FD Adalimumab + MTX
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.
FG007
Open-Label Extension FD Adalimumab
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.
FG00038 subjectsFor all groups, started indicates when the subjects entered the double-blind treatment phase.
FG00137 subjects
FG00230 subjects
FG00328 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG00035 subjects
FG00136 subjects
FG00229 subjects
FG00328 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Sponsor request or decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized in error
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Open-Label Extension BSA Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00471 subjects
FG00557 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Open-Label Extension Fixed Dose Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00659 subjects
FG00747 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Double-Blind Adalimumab + MTX
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.
BG001
Double-Blind Placebo + MTX
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.
BG002
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 (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.
BG003
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 (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.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00038
BG00137
BG00230
BG00328
BG004133
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Age for participants in the Double-Blind Phase only.
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00011.7± 3.29
BG00110.8± 3.36
BG00211.1± 4.13
BG003
Sex: Female, Male
Numbers represent participants in the Double-Blind Phase only.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00030
BG00130
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase
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.
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.
Posted
Number
Participants
Week 16 to Week 48 (32 weeks)
ID
Title
Description
OG000
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 (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.
OG001
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 (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.
Units
Counts
Participants
OG00030
OG00128
Title
Denominators
Categories
Title
Measurements
OG00013
OG00120
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Chi-square test
0.031
95
No
Superiority or Other
Secondary
Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase
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.
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.
Posted
Number
Participants
Week 16
ID
Title
Description
OG000
Adalimumab + MTX
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.
OG001
Adalimumab
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.
Secondary
Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase
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.
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.
Posted
Number
Participants
Week 16 to Week 48 (32 Weeks)
ID
Title
Description
OG000
Double-Blind Adalimumab + MTX
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.
OG001
Double-Blind Placebo + MTX
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.
Secondary
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum
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.
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.
Posted
Number
Percent participants w/o disease flare
Week 16 to Week 48 (32 weeks)
ID
Title
Description
OG000
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 (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.
OG001
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 (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.
Secondary
Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum
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.
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.
Posted
Number
Percent participants w/o disease flare
Week 16 to Week 48 (32 weeks)
ID
Title
Description
OG000
Double-Blind Adalimumab + MTX
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.
OG001
Double-Blind Placebo + MTX
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.
Secondary
Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase
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.
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.
Posted
Number
Participants
Week 48
ID
Title
Description
OG000
Adalimumab
Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
OG001
Placebo
Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
OG002
Adalimumab + MTX
Secondary
Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase
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.
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.
Posted
Number
Participants
Week 48
ID
Title
Description
OG000
Adalimumab
Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
OG001
Placebo
Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
OG002
Adalimumab + MTX
Secondary
Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase
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.
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.
Posted
Number
Participants
Week 48
ID
Title
Description
OG000
Adalimumab
Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
OG001
Placebo
Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
OG002
Adalimumab + MTX
Secondary
Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase
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.
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.
Posted
Mean
Standard Error
Units on a scale
Baseline and Week 48
ID
Title
Description
OG000
Adalimumab
Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
OG001
Placebo
Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
OG002
Adalimumab + MTX
Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
Secondary
Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase
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.
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.
Posted
Mean
Standard Error
Units on a scale
Baseline and Week 48
ID
Title
Description
OG000
Adalimumab
Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
OG001
Placebo
Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
OG002
Adalimumab + MTX
Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
Secondary
Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase
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.
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.
Posted
Mean
Standard Error
mg/dL
Baseline and Week 48
ID
Title
Description
OG000
Adalimumab
Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
OG001
Placebo
Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
OG002
Adalimumab + MTX
Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
OG003
Placebo + MTX
Secondary
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area 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. All core assessments are included in PedACR criteria.
The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.
Posted
May 2011
Number
Participants
Open-Label Lead-In Phase Baseline
ID
Title
Description
OG000
OLE BSA Adalimumab + MTX
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).
OG001
OLE BSA Adalimumab
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).
Secondary
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area 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. All core assessments are included in PedACR criteria.
The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.
Posted
May 2011
Number
Participants
Week 56
ID
Title
Description
OG000
OLE BSA Adalimumab + MTX
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).
OG001
OLE BSA Adalimumab
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).
Secondary
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area 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. All core assessments are included in PedACR criteria.
The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.
Posted
May 2011
Number
Participants
Week 104
ID
Title
Description
OG000
OLE BSA Adalimumab + MTX
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).
OG001
OLE BSA Adalimumab
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).
Secondary
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose 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-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.
The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.
Posted
May 2011
Number
Participants
Baseline
ID
Title
Description
OG000
OLE FD Adalimumab + MTX
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.
OG001
OLE FD Adalimumab
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.
Secondary
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose 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-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.
The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.
Posted
May 2011
Number
Participants
Week 48
ID
Title
Description
OG000
OLE FD Adalimumab + MTX
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.
OG001
OLE FD Adalimumab
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.
Secondary
Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose 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. All core assessments are included in PedACR criteria.
The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.
Posted
May 2011
Number
Participants
Week 112
ID
Title
Description
OG000
OLE FD Adalimumab + MTX
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.
OG001
OLE FD Adalimumab
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.
Secondary
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
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).
The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.
Posted
May 2011
Number
Participants
Final Visit (up to 224 weeks of OLE FD phase)
ID
Title
Description
OG000
OLE FD Adalimumab + MTX
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.
OG001
OLE FD Adalimumab
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.
Other Pre-specified
Baseline Measure: Gender, Female/Male - 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.
Posted
Jul 2011
Number
Participants
Baseline OLE BSA Phase
ID
Title
Description
OG000
OLE BSA Adalimumab + MTX
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).
OG001
OLE BSA Adalimumab
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).
Units
Counts
Participants
Other Pre-specified
Baseline Measure: Age Continuous - 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.
Posted
Jul 2011
Mean
Standard Deviation
Years
Baseline OLE BSA Phase
ID
Title
Description
OG000
OLE BSA Adalimumab + MTX
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).
OG001
OLE BSA Adalimumab
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).
Units
Counts
Participants
Other Pre-specified
Baseline Measure: Gender, Female/Male - 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.
Posted
Jul 2011
Number
Participants
Baseline OLE FD Phase
ID
Title
Description
OG000
OLE FD Adalimumab + MTX
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.
OG001
OLE FD Adalimumab
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.
Units
Counts
Participants
Other Pre-specified
Baseline Measure: Age Continuous - 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.
Posted
Jul 2011
Mean
Standard Deviation
Years
Baseline OLE FD Phase
ID
Title
Description
OG000
OLE FD Adalimumab + MTX
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.
OG001
OLE FD Adalimumab
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.
Units
Counts
Participants
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.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Double-Blind Adalimumab + MTX
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.
3
38
27
38
EG001
Double-Blind Placebo + MTX
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.
2
37
19
37
EG002
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 (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.
1
30
20
30
EG003
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 (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.
0
28
20
28
EG004
Open-Label Extension BSA Adalimumab + MTX
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.
13
71
62
71
EG005
Open-Label Extension BSA Adalimumab
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.
9
57
46
57
EG006
Open-Label Extension FD Adalimumab + MTX
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.
7
59
54
59
EG007
Open-Label Extension FD Adalimumab
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.
10
47
37
47
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG0030 affected28 at risk
EG0041 affected71 at risk
EG0050 affected57 at risk
EG0060 affected59 at risk
EG0071 affected47 at risk
Gastroduodenitis
Gastrointestinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0011 affected37 at risk
EG0020 affected30 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0011 affected37 at risk
EG0020 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0021 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Malabsorption
Gastrointestinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Viral infection
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Joint contracture
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Juvenile arthritis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Speech disorder
Nervous system disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Abortion
Pregnancy, puerperium and perinatal conditions
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Cervicitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Laboratory test abnormal
Investigations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Knee Deformity
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Osteochondrosis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Breast enlargement
Reproductive system and breast disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG0032 affected28 at risk
EG0040 affected71 at risk
EG0050 affected57 at risk
EG0065 affected59 at risk
EG0074 affected47 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0010 affected37 at risk
EG0022 affected30 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0012 affected37 at risk
EG0020 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0022 affected30 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0011 affected37 at risk
EG0020 affected30 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Blister
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0007 affected38 at risk
EG0015 affected37 at risk
EG0022 affected30 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0021 affected30 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0023 affected30 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0011 affected37 at risk
EG0020 affected30 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0004 affected38 at risk
EG0011 affected37 at risk
EG0023 affected30 at risk
EG003
Headache
Nervous system disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0013 affected37 at risk
EG0022 affected30 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0012 affected37 at risk
EG0021 affected30 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0022 affected30 at risk
EG003
Impetigo
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0021 affected30 at risk
EG003
Influenza
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0011 affected37 at risk
EG0020 affected30 at risk
EG003
Influenza like illness
General disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0014 affected37 at risk
EG0020 affected30 at risk
EG003
Injection site burning
General disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0012 affected37 at risk
EG0024 affected30 at risk
EG003
Injection site erythema
General disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0011 affected37 at risk
EG0021 affected30 at risk
EG003
Injection site pain
General disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0007 affected38 at risk
EG0016 affected37 at risk
EG0025 affected30 at risk
EG003
Injection site reaction
General disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0007 affected38 at risk
EG0011 affected37 at risk
EG0023 affected30 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0011 affected37 at risk
EG0020 affected30 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Juvenile arthritis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0011 affected37 at risk
EG0020 affected30 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0011 affected37 at risk
EG0022 affected30 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0005 affected38 at risk
EG0014 affected37 at risk
EG0020 affected30 at risk
EG003
Pain
General disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0011 affected37 at risk
EG0023 affected30 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Paronychia
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0010 affected37 at risk
EG0022 affected30 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0012 affected37 at risk
EG0020 affected30 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Pyrexia
General disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0021 affected30 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0011 affected37 at risk
EG0022 affected30 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0003 affected38 at risk
EG0010 affected37 at risk
EG0022 affected30 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0002 affected38 at risk
EG0010 affected37 at risk
EG0021 affected30 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0010 affected37 at risk
EG0021 affected30 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0001 affected38 at risk
EG0013 affected37 at risk
EG0020 affected30 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0005 affected38 at risk
EG0014 affected37 at risk
EG0026 affected30 at risk
EG003
Viral infection
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0006 affected38 at risk
EG0012 affected37 at risk
EG0026 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0003 affected38 at risk
EG0012 affected37 at risk
EG0020 affected30 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Ear infection
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Otitis media
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Fatigue
General disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 7.0, 12.1 OLE
Non-systematic Assessment
EG0000 affected38 at risk
EG0010 affected37 at risk
EG0020 affected30 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Global Medical Services
Abbott
800-633-9110
ID
Term
D001171
Arthritis, Juvenile
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068879
Adalimumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
59 subjects
FG00547 subjects
FG0060 subjects
FG0070 subjects
12 subjects
FG00510 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0043 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Sponsor request or decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0045 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG00637 subjects
FG00725 subjects
0 subjects
FG0050 subjects
FG00622 subjects
FG00722 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0066 subjects
FG0073 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
Sponsor request or decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0066 subjects
FG0077 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0072 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0065 subjects
FG0078 subjects
11.3
± 3.77
BG00411.2± 3.64
23
BG00320
BG004103
Male
BG0008
BG0017
BG0027
BG0038
BG00430
Units
Counts
Participants
OG00085
OG00186
Title
Denominators
Categories
Title
Measurements
OG00080
OG00164
Units
Counts
Participants
OG00038
OG00137
Title
Denominators
Categories
Title
Measurements
OG00014
OG00124
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chi-square test
0.015
95
No
Superiority or Other
Units
Counts
Participants
OG00030
OG00128
Title
Denominators
Categories
Week 20
Title
Measurements
OG00090.0
OG00178.6
Week 24
Title
Measurements
OG00083.3
OG00164.3
Week 28
Title
Measurements
OG00080.0
OG00160.7
Week 32
Title
Measurements
OG00070.0
OG00146.4
Week 36
Title
Measurements
OG00066.7
OG00146.4
Week 40
Title
Measurements
OG00060.0
OG00139.3
Week 44
Title
Measurements
OG00060.0
OG00132.1
Week 48
Title
Measurements
OG00056.7
OG00128.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.029
95
No
Superiority or Other
Units
Counts
Participants
OG00038
OG00137
Title
Denominators
Categories
Week 20
Title
Measurements
OG00086.8
OG00183.8
Week 24
Title
Measurements
OG00078.9
OG00170.3
Week 28
Title
Measurements
OG00068.4
OG00159.5
Week 32
Title
Measurements
OG00068.4
OG00156.8
Week 36
Title
Measurements
OG00063.2
OG00148.6
Week 40
Title
Measurements
OG00063.2
OG00145.9
Week 44
Title
Measurements
OG00063.2
OG00143.2
Week 48
Title
Measurements
OG00063.2
OG00135.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.031
95
No
Superiority or Other
Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
OG003
Placebo + MTX
Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Units
Counts
Participants
OG00030
OG00128
OG00238
OG00337
Title
Denominators
Categories
Title
Measurements
OG00017
OG0019
OG00224
OG00314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-square test
0.061
95
No
Superiority or Other
OG002
OG003
Pearson's Chi-square test
0.028
95
No
Superiority or Other
Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
OG003
Placebo + MTX
Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Units
Counts
Participants
OG00030
OG00128
OG00238
OG00337
Title
Denominators
Categories
Title
Measurements
OG00016
OG0019
OG00224
OG00314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-square test
0.103
95
No
Superiority or Other
OG002
OG003
Pearson's Chi-square test
0.028
95
No
Superiority or Other
Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
OG003
Placebo + MTX
Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Units
Counts
Participants
OG00030
OG00128
OG00238
OG00337
Title
Denominators
Categories
Title
Measurements
OG00014
OG0018
OG00224
OG00310
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pearson's Chi-square test
0.156
95
No
Superiority or Other
OG002
OG003
Pearson's Chi-square test
0.002
95
No
Superiority or Other
OG003
Placebo + MTX
Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Units
Counts
Participants
OG00017
OG0019
OG00224
OG00315
Title
Denominators
Categories
Title
Measurements
OG000-52.06± 3.713
OG001-38.73± 6.554
OG002-48.50± 3.890
OG003-38.73± 6.554
OG003
Placebo + MTX
Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
Units
Counts
Participants
OG00017
OG0019
OG00224
OG00315
Title
Denominators
Categories
Title
Measurements
OG000-41.53± 5.562
OG001-50.56± 6.129
OG002-36.42± 5.177
OG003-26.87± 5.644
Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.