Study of the Optimal Protocol for Methotrexate and Adalim... | NCT00420927 | Trialant
NCT00420927
Sponsor
Abbott
Status
Completed
Last Update Posted
Apr 18, 2012Estimated
Enrollment
1,032Actual
Phase
Phase 4
Conditions
Rheumatoid Arthritis
Interventions
adalimumab
methotrexate
placebo
Countries
United States
Argentina
Australia
Austria
Belgium
Canada
Czechia
France
Germany
Hungary
Mexico
Netherlands
New Zealand
Norway
Poland
Puerto Rico
Slovakia
South Africa
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00420927
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M06-810
Secondary IDs
ID
Type
Description
Link
2006-004139-31
EudraCT Number
Brief Title
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis
Official Title
A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
Acronym
OPTIMA
Organization
AbbottINDUSTRY
Status Module
Record Verification Date
Apr 2012
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
Dec 2006
Primary Completion Date
Jul 2010Actual
Completion Date
Jul 2010Actual
First Submitted Date
Jan 9, 2007
First Submission Date that Met QC Criteria
Jan 10, 2007
First Posted Date
Jan 11, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 1, 2011
Results First Submitted that Met QC Criteria
Aug 24, 2011
Results First Posted Date
Sep 29, 2011Estimated
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
Apr 16, 2012
Last Update Posted Date
Apr 18, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbottINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).
Detailed Description
This was a 78-week, multicenter, randomized, double-blind, double-treatment period study designed to compare the safety and efficacy of adalimumab and MTX with placebo and MTX in subjects with early RA. Subjects were randomized to receive adalimumab 40 mg every other week (eow) or placebo subcutaneous injections in combination with orally administered MTX for 26 weeks (Period 1). All subjects in all arms received open-label MTX weekly throughout the study (both Period 1 and Period 2).
At Weeks 22 and 26, subjects were assessed for achievement of low disease activity, defined as a DAS28 score below 3.2. DAS28 is a measure of RA disease activity calculated using the number of tender and swollen joints (out of a total of 28), C-reactive protein level (CRP, a blood marker of inflammation), and the patient's global assessment of disease activity (indicated by marking a 10 cm line between very good and very bad). Subjects who achieved low disease activity at Week 22 and 26 in the adalimumab arm at the end of Period 1 were randomized to receive MTX monotherapy (placebo and MTX) or combination therapy (adalimumab and MTX) in a 1:1 ratio for the duration of Period 2 (52 weeks, i.e., to Week 78 of the study). Subjects achieving low disease activity at Week 22 and 26 in the placebo arm (MTX monotherapy) at the end of Period 1 continued to receive MTX monotherapy (and placebo injections in a blinded fashion) for the duration of Period 2. Subjects failing to achieve low disease activity at Week 22 and 26 at the end of Period 1 received open-label combination therapy during Period 2 regardless of treatment assignment in Period 1.
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Early Rheumatoid Arthritis
Tumor Necrosis Factor Optimization
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 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,032Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ADA+MTX/PBO+MTX (Arm 1)
Experimental
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
Biological: adalimumab
Drug: methotrexate
Biological: placebo
ADA+MTX/ADA+MTX (Arm2)
Experimental
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
Biological: adalimumab
Drug: methotrexate
ADA+MTX/OL ADA+MTX (Arm 3)
Experimental
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA + MTX during Period 2
Biological: adalimumab
Drug: methotrexate
PBO+MTX/PBO+MTX (Arm 4)
Experimental
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
Drug: methotrexate
Biological: placebo
PBO+MTX/OL ADA+MTX (Arm 5)
Experimental
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
adalimumab
Biological
Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
ADA+MTX/ADA+MTX (Arm2)
ADA+MTX/OL ADA+MTX (Arm 3)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
Week 78
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Subject must be 18 or older and in good health
Subject must meet the definition of early rheumatoid arthritis (RA) defined by the 1987-revised American College of Rheumatology (ACR) classification criteria and had disease duration of less than 1 year from diagnosis
Subject must have a Disease Activity Score (DAS28, based on C-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed
Subject must fulfill at least one of the following three criteria:
Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy
Subject has received any biologic or investigational therapy within 6 weeks prior to Baseline
Subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.
Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL. Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials. Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
FG001
PBO+MTX
Methotrexate (MTX) monotherapy plus blinded placebo during Period 1
Periods
Title
Milestones
Reasons Not Completed
Period 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Greece
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Biological: adalimumab
Drug: methotrexate
Biological: placebo
ADA+MTX/PBO+MTX (Arm 1)
PBO+MTX/OL ADA+MTX (Arm 5)
Humira
D2E7
methotrexate
Drug
Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week.
ADA+MTX/ADA+MTX (Arm2)
ADA+MTX/OL ADA+MTX (Arm 3)
ADA+MTX/PBO+MTX (Arm 1)
PBO+MTX/OL ADA+MTX (Arm 5)
PBO+MTX/PBO+MTX (Arm 4)
placebo
Biological
Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
ADA+MTX/PBO+MTX (Arm 1)
PBO+MTX/OL ADA+MTX (Arm 5)
PBO+MTX/PBO+MTX (Arm 4)
Week 78
Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.
Week 78
Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.
Week 78
Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78
For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
Week 78
Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78
Subjects were responders if they had greater than or equal to 20% improvement in tender joint count; greater than or equal to 20% improvement in swollen joint count; and greater than or equal to 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).
Week 78
Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78
Subjects were responders if they had: greater than or equal to 50% improvement in tender joint count; greater than or equal to 50% improvement in swollen joint count; and greater than or equal to 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).
Week 78
Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78
Subjects were responders if they had: greater than or equal to 70% improvement in tender joint count; greater than or equal to 70% improvement in swollen joint count; and greater than or equal to 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).
Week 78
Change From Baseline in DAS28 Score at Week 78
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.
Baseline to Week 78
Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78
The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.
Week 78
Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78
The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.
Week 78
Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78
The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.
Week 78
Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78
The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.
Week 78
Change From Baseline in CDAI Score at Week 78
The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.
Baseline to Week 78
Change From Baseline in SDAI Score at Week 78
The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.
Baseline to Week 78
Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78
Synovitis was assessed using high-field magnetic resonance imaging (MRI) of the hand and wrist. Images were read and scored according to the Outcomes Measures in Rheumatology Clinical Trials' Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS). Synovitis in the wrist and finger joints in the most affected hand was scored from 0 (normal) to 3 (severe), for a maximum total score of 21.
Baseline to Week 78
Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78
In the Health Assessment Questionnaire Disability Index (HAQ-DI), participants rated their ability to perform daily tasks on a scale of 0 (without any difficulty) to 3 (unable to do). A mean score of 0-1 represents mild to moderate functional disability, 1-2 represents moderate to severe, 2-3 severe to very severe disability. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
Week 78
Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78
In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (worst joint damage). American College of Rheumatology 70% (ACR70) response indicates at least 70% improvement in tender and swollen joint counts and at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; HAQ-DI; and C-reactive protein.
Week 78
Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78
In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (severe joint damage). The Disease Activity Score (DAS28) ranges from 0.49 to 9.07, with scores less than 2.6 indicating clinical remission.
Smolen JS, van Vollenhoven RF, Florentinus S, Chen S, Suboticki JL, Kavanaugh A. Predictors of disease activity and structural progression after treatment with adalimumab plus methotrexate or continued methotrexate monotherapy in patients with early rheumatoid arthritis and suboptimal response to methotrexate. Ann Rheum Dis. 2018 Nov;77(11):1566-1572. doi: 10.1136/annrheumdis-2018-213502. Epub 2018 Aug 3.
Keystone EC, Breedveld FC, van der Heijde D, van Vollenhoven RF, Emery P, Smolen JS, Sainsbury I, Florentinus S, Kupper H, Chen K, Kavanaugh A. Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. eCollection 2017.
Smolen JS, Emery P, Fleischmann R, van Vollenhoven RF, Pavelka K, Durez P, Guerette B, Kupper H, Redden L, Arora V, Kavanaugh A. Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: the randomised controlled OPTIMA trial. Lancet. 2014 Jan 25;383(9914):321-32. doi: 10.1016/S0140-6736(13)61751-1. Epub 2013 Oct 26.
FG002
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
FG003
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
FG004
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
FG005
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
FG006
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
FG000515 subjects
FG001517 subjects
FG0020 subjectsThis treatment group is not relevant to Period 1.
FG0030 subjectsThis treatment group is not relevant to Period 1.
FG0040 subjectsThis treatment group is not relevant to Period 1.
FG0050 subjectsThis treatment group is not relevant to Period 1.
FG0060 subjectsThis treatment group is not relevant to Period 1.
COMPLETED
FG000466 subjects
FG001460 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00049 subjects
FG00157 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG00019 subjects
FG00115 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0007 subjects
FG00112 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0008 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of efficacy/Loss of efficacy
FG0001 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject moved/relocated
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Noncompliant with study drug
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomization error
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Suspected tuberculosis/positive test
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Study site closure
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject received new diagnosis
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Received wrong treatment/incorrect dose
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Failed to meet entry criteria
FG0008 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
FG004
Took prohibited medication
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Period 2
Type
Comment
Milestone Data
STARTED
FG0000 subjectsThis treatment group is not relevant to Period 2.
FG0010 subjectsThis treatment group is not relevant to Period 2.
FG002102 subjects
FG003105 subjects
FG004259 subjects
FG005112 subjects
FG006348 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00289 subjects
FG00395 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00213 subjects
FG00310 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ADA+MTX
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
BG001
PBO+MTX
Methotrexate (MTX) monotherapy plus blinded placebo(PBO) during Period 1
BG002
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
BG003
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
BG004
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
BG005
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
BG006
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000515
BG001517
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071032
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Categorical
Number
participants
Title
Denominators
Categories
<=18 years
Title
Measurements
BG0000
BG0010
BG0070
Between 18 and 65 years
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00050.7± 14.48
BG00150.4± 13.62
BG007
Gender
Number
participants
Title
Denominators
Categories
Female
Title
Measurements
BG000380
BG001382
BG007
Region of Enrollment
Number
participants
Title
Denominators
Categories
Argentina
Title
Measurements
BG00032
BG00129
BG007
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 With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
The analysis was performed on the ITT Population comprised of all subjects who entered Period 2 and received at least 1 dose of study drug (blinded or open-label) during Period 2. Nonresponder imputation was used for missing data.
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003
Title
Denominators
Categories
Title
Measurements
OG00059
OG00173
OG00294
OG003
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
OG001
OG003
Chi-squared
P value is from Pearson's chi-square test.
0.023
95
No
Superiority or Other
Secondary
Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Secondary
Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.
ITT Population, Nonresponder imputation
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Secondary
Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.
ITT Population, nonresponder imputation
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Secondary
Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78
For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
ITT Population, nonresponder imputation
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Secondary
Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78
Subjects were responders if they had greater than or equal to 20% improvement in tender joint count; greater than or equal to 20% improvement in swollen joint count; and greater than or equal to 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).
ITT Population, nonresponder imputation
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Secondary
Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78
Subjects were responders if they had: greater than or equal to 50% improvement in tender joint count; greater than or equal to 50% improvement in swollen joint count; and greater than or equal to 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).
ITT Population, nonresponder imputation
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Secondary
Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78
Subjects were responders if they had: greater than or equal to 70% improvement in tender joint count; greater than or equal to 70% improvement in swollen joint count; and greater than or equal to 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).
ITT Population, nonresponder imputation
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Secondary
Change From Baseline in DAS28 Score at Week 78
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline to Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
OG003
Secondary
Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78
The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
OG003
PBO+MTX/PBO+MTX (Arm 4)
Secondary
Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78
The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
OG003
PBO+MTX/PBO+MTX (Arm 4)
Secondary
Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78
The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
OG003
PBO+MTX/PBO+MTX (Arm 4)
Secondary
Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78
The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
OG003
PBO+MTX/PBO+MTX (Arm 4)
Secondary
Change From Baseline in CDAI Score at Week 78
The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline to Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
Secondary
Change From Baseline in SDAI Score at Week 78
The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline to Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
OG003
PBO+MTX/PBO+MTX (Arm 4)
Secondary
Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78
Synovitis was assessed using high-field magnetic resonance imaging (MRI) of the hand and wrist. Images were read and scored according to the Outcomes Measures in Rheumatology Clinical Trials' Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS). Synovitis in the wrist and finger joints in the most affected hand was scored from 0 (normal) to 3 (severe), for a maximum total score of 21.
The analysis is based on the Primary Analysis Set, a subset of the ITT Analysis Set that includes subjects who participated in the 78-week HF MRI substudy and whose Baseline HF MRI data were collected on or before the first study drug dose. Observed scores are used in the analysis.
Posted
Mean
Standard Deviation
Scores on a scale
Baseline to Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Secondary
Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78
In the Health Assessment Questionnaire Disability Index (HAQ-DI), participants rated their ability to perform daily tasks on a scale of 0 (without any difficulty) to 3 (unable to do). A mean score of 0-1 represents mild to moderate functional disability, 1-2 represents moderate to severe, 2-3 severe to very severe disability. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Secondary
Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78
In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (worst joint damage). American College of Rheumatology 70% (ACR70) response indicates at least 70% improvement in tender and swollen joint counts and at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; HAQ-DI; and C-reactive protein.
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Secondary
Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78
In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (severe joint damage). The Disease Activity Score (DAS28) ranges from 0.49 to 9.07, with scores less than 2.6 indicating clinical remission.
Posted
Number
Participants
Week 78
ID
Title
Description
OG000
ADA+MTX/PBO+MTX (Arm 1)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
OG001
ADA+MTX/ADA+MTX (Arm 2)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
OG002
ADA+MTX/OL ADA+MTX (Arm 3)
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
Time Frame
Adverse events reported during Period 1 (Weeks 0 to 26) are presented by Period 1 treatment group. Adverse events reported during Period 2 (Weeks 26 to 78) are presented by Period 2 treatment arm (Arm 1 through Arm 5).
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
ADA+MTX/PBO+MTX (Arm 1)
Blinded combination ADA+MTX therapy during Period 1 and blinded MTX monotherapy during Period 2
11
102
28
102
EG001
ADA+MTX/ADA+MTX (Arm 2)
Blinded combination ADA+MTX therapy during Period 1 and Period 2
12
105
38
105
EG002
ADA+MTX/OL ADA+MTX (Arm 3)
Blinded combination therapy during Period 1, open-label combination therapy during Period 2
18
259
106
259
EG003
PBO+MTX/PBO+MTX (Arm 4)
Blinded MTX monotherapy during Period 1 and Period 2
9
112
44
112
EG004
PBO+MTX/OL ADA+MTX (Arm 5)
Blinded MTX monotherapy during Period 1, open-label combination therapy during Period 2
32
348
134
348
EG005
Period 1 ADA+MTX
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
37
515
149
515
EG006
Period 1 PBO+MTX
Combination therapy with methotrexate (MTX) and blinded placebo (PBO) during Period 1
32
517
128
517
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal hernia
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG0031 affected112 at risk
EG0040 affected348 at risk
EG0050 affected515 at risk
EG0060 affected517 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
Adverse event resulted in death of subject
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Acute stress disorder
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Alveolitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Atypical mycobacterial infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Benign mediastinal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0012 affected105 at risk
EG0020 affected259 at risk
EG003
Bile duct cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0022 affected259 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
Adverse event resulted in death of subject
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Candida sepsis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Carotid artery aneurysm
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Cataract
Eye disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
Adverse event resulted in death of subject, who also had a fatal adverse event of facial palsy (cause of death possibly cerebrovascular accident)
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Coronary artery insufficiency
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Death
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Drug intolerance
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Facial palsy
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
Adverse event resulted in death of subject, who also had a fatal adverse event of confusional state (cause of death possibly cerebrovascular accident)
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Gangrene
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Gastric dilatation
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Influenza
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
Adverse event resulted in death of 2 subjects in ADA+MTX group during Period 1
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Ischaemic hepatitis
Hepatobiliary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Kidney rupture
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Knee deformity
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Medical device complication
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Microgenia
Congenital, familial and genetic disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Micromastia
Reproductive system and breast disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Monarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Oedematous pancreatitis
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Oesophageal achalasia
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Oesophageal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Orchitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Peritoneal tuberculosis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Physical abuse
Social circumstances
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
Adverse event resulted in death of 1 subject in Arm 5
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Pneumonia legionella
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Pyrexia
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
Adverse event resulted in death of subject
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Sepsis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Staphylococcal abscess
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Sudden death
General disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Syncope
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0021 affected259 at risk
EG003
Viral infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0011 affected105 at risk
EG0020 affected259 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Vulvovaginitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0000 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0010 affected105 at risk
EG0020 affected259 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Alanine aminotransferase increased
Investigations
MedDRA 13.0
Non-systematic Assessment
EG0005 affected102 at risk
EG0014 affected105 at risk
EG00216 affected259 at risk
EG0033 affected112 at risk
EG00416 affected348 at risk
EG00511 affected515 at risk
EG00614 affected517 at risk
Bronchitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0003 affected102 at risk
EG0012 affected105 at risk
EG00214 affected259 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0003 affected102 at risk
EG0017 affected105 at risk
EG00213 affected259 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0011 affected105 at risk
EG00210 affected259 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.0
Non-systematic Assessment
EG0002 affected102 at risk
EG0013 affected105 at risk
EG0029 affected259 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.0
Non-systematic Assessment
EG0001 affected102 at risk
EG0015 affected105 at risk
EG0026 affected259 at risk
EG003
Influenza
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0003 affected102 at risk
EG0016 affected105 at risk
EG0029 affected259 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0005 affected102 at risk
EG0016 affected105 at risk
EG00223 affected259 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.0
Non-systematic Assessment
EG0007 affected102 at risk
EG0014 affected105 at risk
EG00215 affected259 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0003 affected102 at risk
EG0012 affected105 at risk
EG0029 affected259 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0005 affected102 at risk
EG0015 affected105 at risk
EG00229 affected259 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.0
Non-systematic Assessment
EG0002 affected102 at risk
EG0015 affected105 at risk
EG00212 affected259 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
Any investigator or institution that plans on presenting/publishing results disclosure, should provide written notification to Abbott within 60 days of their presentation/publication. Abbott requests that no presentation/publication will be allowed until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay of any proposed presentation/publication maybe requested if Abbott needs to secure patent or other proprietary protection.
Point of Contact
Title
Organization
Phone
Extension
Email
Global Medical Services
Abbott
1-800-633-9110
ID
Term
D001172
Arthritis, Rheumatoid
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
D008727
Methotrexate
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
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
216 subjects
FG00597 subjects
FG006295 subjects
43 subjects
FG00515 subjects
FG00653 subjects
3 subjects
FG00417 subjects
FG0056 subjects
FG00620 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG00411 subjects
FG0052 subjects
FG00612 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG0046 subjects
FG0053 subjects
FG0069 subjects
Lack of efficacy/Loss of efficacy
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG0046 subjects
FG0052 subjects
FG0066 subjects
Received wrong treatment/incorrect dose
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Subject unable to find transportation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
Sponsor decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Randomization error
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
Noncompliant with study drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
Methotrexate intolerance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Took prohibited medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Title
Measurements
BG000418
BG001431
BG007849
>=65 years
Title
Measurements
BG00097
BG00186
BG007183
50.6
± 14.05
762
Male
Title
Measurements
BG000135
BG001135
BG007270
61
Australia
Title
Measurements
BG0005
BG0018
BG00713
Austria
Title
Measurements
BG00011
BG00112
BG00723
Belgium
Title
Measurements
BG00041
BG00140
BG00781
Canada
Title
Measurements
BG00057
BG00158
BG007115
Czech Republic
Title
Measurements
BG00022
BG00119
BG00741
France
Title
Measurements
BG0004
BG0018
BG00712
Germany
Title
Measurements
BG00043
BG00141
BG00784
Hungary
Title
Measurements
BG0008
BG00110
BG00718
Mexico
Title
Measurements
BG00026
BG00127
BG00753
Netherlands
Title
Measurements
BG0000
BG0013
BG0073
New Zealand
Title
Measurements
BG0003
BG0013
BG0076
Norway
Title
Measurements
BG0004
BG0015
BG0079
Poland
Title
Measurements
BG00012
BG0019
BG00721
Slovakia
Title
Measurements
BG0006
BG0013
BG0079
South Africa
Title
Measurements
BG00031
BG00132
BG00763
Spain
Title
Measurements
BG00025
BG00130
BG00755
Sweden
Title
Measurements
BG00010
BG00111
BG00721
United Kingdom
Title
Measurements
BG00026
BG00117
BG00743
United States
Title
Measurements
BG000149
BG001152
BG007301
112
OG004348
61
OG004129
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00059
OG00173
OG00294
OG00361
OG004129
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
Regression, Logistic
0.082
95
No
Superiority or Other
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00071
OG00180
OG002108
OG00378
OG004185
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
OG001
OG003
Regression, Logistic
0.280
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.287
95
No
Superiority or Other
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00057
OG00177
OG00271
OG00366
OG004138
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
OG001
OG003
Regression, Logistic
0.026
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.009
95
No
Superiority or Other
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001102
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00070
OG00184
OG002182
OG00377
OG004220
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
OG001
OG003
Regression, Logistic
0.060
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.063
95
No
Superiority or Other
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00084
OG00189
OG002172
OG00390
OG004257
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
OG001
OG003
Regression, Logistic
0.395
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.640
95
No
Superiority or Other
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00072
OG00182
OG002120
OG00378
OG004198
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
OG001
OG003
Regression, Logistic
0.159
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.217
95
No
Superiority or Other
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00057
OG00173
OG00278
OG00364
OG004137
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
OG001
OG003
Regression, Logistic
0.060
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.043
95
No
Superiority or Other
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG000-3.54± 1.259
OG001-3.71± 1.134
OG002-2.70± 1.531
OG003-3.04± 1.513
OG004-3.07± 1.486
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
OG001
OG003
ANCOVA
Analysis of covariance adjusting for baseline
0.004
95
No
Superiority or Other
OG000
OG001
ANCOVA
Analysis of covariance adjusting for baseline
0.049
95
No
Superiority or Other
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00075
OG00184
OG002109
OG00382
OG004195
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
OG001
OG003
Regression, Logistic
0.240
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.271
95
No
Superiority or Other
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00073
OG00179
OG002106
OG00376
OG004192
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
OG001
OG003
Regression, Logistic
0.230
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.550
95
No
Superiority or Other
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00047
OG00158
OG00239
OG00354
OG00494
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
OG001
OG003
Regression, Logistic
0.301
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.188
95
No
Superiority or Other
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00045
OG00155
OG00239
OG00351
OG00492
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
OG001
OG003
Regression, Logistic
0.314
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.235
95
No
Superiority or Other
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG000-33.30± 12.808
OG001-33.29± 12.964
OG002-29.06± 16.561
OG003-27.63± 15.526
OG004-31.30± 14.769
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
OG001
OG003
ANCOVA
Analysis of covariance adjusting for baseline
0.030
95
No
Superiority or Other
OG000
OG001
ANCOVA
Analysis of covariance adjusting for baseline
0.403
95
No
Superiority or Other
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG000-35.61± 13.527
OG001-35.16± 13.784
OG002-31.00± 17.856
OG003-29.30± 17.120
OG004-33.43± 15.852
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
OG001
OG003
ANCOVA
Analysis of covariance adjusting for baseline
0.036
95
No
Superiority or Other
OG000
OG001
ANCOVA
Analysis of covariance adjusting for baseline
0.349
95
No
Superiority or Other
Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG0002
OG0014
OG00214
OG0034
OG00413
Title
Denominators
Categories
Title
Measurements
OG0002.00± 2.121
OG001-3.38± 2.562
OG002-3.25± 3.631
OG003-3.88± 3.351
OG004-4.27± 4.211
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
OG001
OG003
ANCOVA
Analysis of covariance adjusting for baseline
0.037
95
No
Superiority or Other
OG000
OG001
ANCOVA
Analysis of covariance adjusting for baseline
<0.001
95
No
Superiority or Other
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00049
OG00159
OG00265
OG00353
OG00484
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
OG001
OG003
Regression, Logistic
0.192
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.241
95
No
Superiority or Other
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
Units
Counts
Participants
OG000102
OG001105
OG002259
OG003112
OG004348
Title
Denominators
Categories
Title
Measurements
OG00037
OG00156
OG00240
OG00343
OG00467
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
OG001
OG003
Regression, Logistic
0.028
95
No
Superiority or Other
OG000
OG001
Regression, Logistic
0.014
95
No
Superiority or Other
OG003
PBO+MTX/PBO+MTX (Arm 4)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
OG004
PBO+MTX/OL ADA+MTX (Arm 5)
Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2