Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.
Detailed description
This was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. Data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through Week 52 and for all patients who received at least one dose of adalimumab during the 10-year study (the Intent-to-Treat \[ITT\] population).
Interventions
BIOLOGICALAdalimumab
Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
DRUGPlacebo
Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older and in good health (Investigator discretion) with a recent stable medical history * Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid arthritis (RA) and had at both screening and baseline visits \>=6 swollen joints and \>=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints \[DIPs\] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs \[DMARDs\] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.) * Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX intolerant). * If patient on a second-line treatment (DMARD) other than MTX, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period). * Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week. * Both rheumatoid factor positivity and a C-reactive protein value \>=1 mg/dL, or at least one joint erosion on X-ray.
Exclusion criteria
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study. * Female subject who was pregnant or breast-feeding or considering becoming pregnant. * Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab. * Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide. * Intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit. * Subject was wheelchair bound or bedridden.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24 | Week 24 | Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders. |
| Change From Baseline in Modified Total Sharp X-ray Score at Week 52 | Baseline and Week 52 | Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease. |
| Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52 | Baseline and Week 52 | Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24 | Week 52 | Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a \>= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24. |
| Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Week 52 | Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders. |
| Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment | Baseline through Week 52 | Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders. |
| Number of Participants Meeting ACR20 Response Criteria at Week 52 | Week 52 | Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders. |
| Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Baseline through Week 52 | Patients were responders if they had: \>= 50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders. |
| Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Baseline through Week 52 | Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders. |
| Estimated Yearly Progression of Rheumatoid Arthritis | Baseline and Week 52 | Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease). |
| Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Baseline through Week 52 | Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders. |
| Change From Baseline in Modified Total Sharp X-ray Score at Week 24 | Baseline and Week 24 | Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease. |
| Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24 | Baseline and Week 24 | Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Modified Total Sharp X-ray Score at Week 416 | Baseline and Week 416 | Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease. |
| Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat) | Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group | Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section. |
| Change From Baseline in Modified Total Sharp X-ray Score at Week 520 | Baseline and Week 520 | Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease. |
| Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat) | Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group | Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section. |
| Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260 | Week 260 | Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. |
| Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520 | Week 520 | Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. |
| Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260 | Week 260 | Patients were responders if they had: \>= 50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 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. |
| Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520 | Week 520 | Patients were responders if they had: \>= 50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 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. |
| Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260 | Week 260 | Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 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. |
| Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520 | Week 520 | Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 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. |
| Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10 | Baseline through Week 520 | Patients were responders if they had: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=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. |
| Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260 | Week 260 | The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change. |
| Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520 | Week 520 | The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change. |
| Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260 | Baseline and Week 260 | Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement. |
| Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520 | Baseline and Week 520 | Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement. |
Countries
Canada, United States
Participant flow
Recruitment details
Subjects were enrolled at 95 sites in the United States and Canada between February 2000 and August 2001.
Pre-assignment details
Eligible subjects who were taking disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) entered a 4- to 6-week washout period, during which previous DMARDs (except MTX) were discontinued. Subjects who were not taking DMARDs, other than MTX, entered directly into the 52-week double-blind treatment period of the study.
Participants by arm
| Arm | Count |
|---|---|
| DB Adalimumab 20 mg ew Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase. | 212 |
| DB Adalimumab 40 mg Eow Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase. | 207 |
| DB Placebo ew Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase. | 200 |
| Total | 619 |
Baseline characteristics
| Characteristic | DB Adalimumab 20 mg ew | DB Adalimumab 40 mg Eow | DB Placebo ew | Total |
|---|---|---|---|---|
| Age, Customized < 40 years | 10 participants | 27 participants | 18 participants | 55 participants |
| Age, Customized >= 75 years | 11 participants | 11 participants | 10 participants | 32 participants |
| Age, Customized Between 40 and 64 years | 150 participants | 115 participants | 137 participants | 402 participants |
| Age, Customized Between 65 and 74 years | 41 participants | 54 participants | 35 participants | 130 participants |
| Sex: Female, Male Female | 160 Participants | 158 Participants | 146 Participants | 464 Participants |
| Sex: Female, Male Male | 52 Participants | 49 Participants | 54 Participants | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 167 / 212 | 148 / 207 | 149 / 200 | 511 / 553 |
| serious Total, serious adverse events | 34 / 212 | 27 / 207 | 20 / 200 | 271 / 553 |
Outcome results
Primary
Change From Baseline in Modified Total Sharp X-ray Score at Week 52
Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.
Time frame: Baseline and Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 24 or early termination.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Change From Baseline in Modified Total Sharp X-ray Score at Week 52 | 0.8 Units on a scale | Standard Deviation 4.9 |
| DB Adalimumab 40 mg Eow | Change From Baseline in Modified Total Sharp X-ray Score at Week 52 | 0.1 Units on a scale | Standard Deviation 4.8 |
| DB Placebo ew | Change From Baseline in Modified Total Sharp X-ray Score at Week 52 | 2.7 Units on a scale | Standard Deviation 6.8 |
Comparison: The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.p-value: <0.001ANCOVA
Comparison: The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.p-value: <0.001ANCOVA
Primary
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.
Time frame: Baseline and Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Last observation carried forward (LOCF) data analysis was used for missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52 | -0.61 Units on a scale | Standard Deviation 0.55 |
| DB Adalimumab 40 mg Eow | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52 | -0.59 Units on a scale | Standard Deviation 0.57 |
| DB Placebo ew | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52 | -0.25 Units on a scale | Standard Deviation 0.56 |
Comparison: The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.p-value: <0.001ANCOVA
Comparison: The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.p-value: <0.001ANCOVA
Primary
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Time frame: Week 24
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24 | 129 Participants |
| DB Adalimumab 40 mg Eow | Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24 | 131 Participants |
| DB Placebo ew | Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24 | 59 Participants |
Comparison: The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.p-value: <0.001Chi-squared
Comparison: The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.p-value: <0.001Chi-squared
Secondary
Change From Baseline in Modified Total Sharp X-ray Score at Week 24
Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.
Time frame: Baseline and Week 24
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Change From Baseline in Modified Total Sharp X-ray Score at Week 24 | 0.6 Units on a scale | Standard Deviation 4.9 |
| DB Adalimumab 40 mg Eow | Change From Baseline in Modified Total Sharp X-ray Score at Week 24 | 0.3 Units on a scale | Standard Deviation 4.5 |
| DB Placebo ew | Change From Baseline in Modified Total Sharp X-ray Score at Week 24 | 1.3 Units on a scale | Standard Deviation 3.7 |
p-value: <0.01ANCOVA
p-value: <0.001ANCOVA
Secondary
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.
Time frame: Baseline and Week 24
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. LOCF data analysis was used for missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24 | -0.60 Units on a scale | Standard Deviation 0.53 |
| DB Adalimumab 40 mg Eow | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24 | -0.56 Units on a scale | Standard Deviation 0.52 |
| DB Placebo ew | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24 | -0.24 Units on a scale | Standard Deviation 0.52 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Estimated Yearly Progression of Rheumatoid Arthritis
Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).
Time frame: Baseline and Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DB Adalimumab 20 mg ew | Estimated Yearly Progression of Rheumatoid Arthritis | Estimated yearly progression | 11.11 Units on a scale | Standard Deviation 16.75 |
| DB Adalimumab 20 mg ew | Estimated Yearly Progression of Rheumatoid Arthritis | Actual progression during study | 0.77 Units on a scale | Standard Deviation 4.9 |
| DB Adalimumab 40 mg Eow | Estimated Yearly Progression of Rheumatoid Arthritis | Estimated yearly progression | 9.46 Units on a scale | Standard Deviation 10.42 |
| DB Adalimumab 40 mg Eow | Estimated Yearly Progression of Rheumatoid Arthritis | Actual progression during study | 0.09 Units on a scale | Standard Deviation 4.75 |
| DB Placebo ew | Estimated Yearly Progression of Rheumatoid Arthritis | Estimated yearly progression | 9.97 Units on a scale | Standard Deviation 12.84 |
| DB Placebo ew | Estimated Yearly Progression of Rheumatoid Arthritis | Actual progression during study | 2.66 Units on a scale | Standard Deviation 6.73 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Time frame: Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were ACR20 responders at Week 24 were evaluated to determine whether the response was maintained. Observed data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Did Not Maintain Response | 21 Participants |
| DB Adalimumab 20 mg ew | Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Maintained Response | 99 Participants |
| DB Adalimumab 20 mg ew | Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Missing | 9 Participants |
| DB Adalimumab 40 mg Eow | Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Did Not Maintain Response | 12 Participants |
| DB Adalimumab 40 mg Eow | Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Maintained Response | 111 Participants |
| DB Adalimumab 40 mg Eow | Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Missing | 8 Participants |
| DB Placebo ew | Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Maintained Response | 32 Participants |
| DB Placebo ew | Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Missing | 4 Participants |
| DB Placebo ew | Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 | Did Not Maintain Response | 23 Participants |
Secondary
Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a \>= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.
Time frame: Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were responders at Week 12 or 24 were evaluated to determine whether the response was maintained. LOCF data analysis was used for missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24 | Maintained Response | 130 Participants |
| DB Adalimumab 20 mg ew | Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24 | Did Not Maintain Response | 7 Participants |
| DB Adalimumab 40 mg Eow | Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24 | Maintained Response | 121 Participants |
| DB Adalimumab 40 mg Eow | Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24 | Did Not Maintain Response | 4 Participants |
| DB Placebo ew | Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24 | Maintained Response | 73 Participants |
| DB Placebo ew | Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24 | Did Not Maintain Response | 9 Participants |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
Secondary
Number of Participants Meeting ACR20 Response Criteria at Week 52
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Time frame: Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants Meeting ACR20 Response Criteria at Week 52 | 116 Participants |
| DB Adalimumab 40 mg Eow | Number of Participants Meeting ACR20 Response Criteria at Week 52 | 122 Participants |
| DB Placebo ew | Number of Participants Meeting ACR20 Response Criteria at Week 52 | 48 Participants |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
Secondary
Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment
Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Time frame: Baseline through Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment | 20 Participants |
| DB Adalimumab 40 mg Eow | Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment | 18 Participants |
| DB Placebo ew | Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment | 3 Participants |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
Secondary
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Time frame: Baseline through Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR20 response criteria for the first time at each time point is presented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Non-responder | 25 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 2 | 69 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 4 | 48 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 8 | 29 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 12 | 17 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 16 | 7 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 20 | 8 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 24 | 2 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 32 | 4 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 40 | 0 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 48 | 1 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 52 | 2 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 52 | 0 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Non-responder | 29 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 20 | 7 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 32 | 2 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 2 | 53 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 16 | 8 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 48 | 0 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 4 | 48 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 24 | 2 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 12 | 23 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 8 | 33 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 40 | 2 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 8 | 21 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 12 | 14 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 40 | 1 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 16 | 12 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 20 | 3 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 24 | 7 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 48 | 2 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Non-responder | 81 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 2 | 26 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 32 | 2 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 4 | 30 Participants |
| DB Placebo ew | Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point | Week 52 | 1 Participants |
Secondary
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Patients were responders if they had: \>= 50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Time frame: Baseline through Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR50 response criteria for the first time at each time point is presented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Non-responder | 71 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 2 | 18 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 4 | 17 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 8 | 26 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 12 | 25 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 16 | 23 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 20 | 16 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 24 | 7 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 32 | 4 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 40 | 3 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 48 | 1 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 52 | 1 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 52 | 3 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Non-responder | 69 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 20 | 10 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 32 | 7 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 2 | 13 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 16 | 21 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 48 | 3 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 4 | 26 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 24 | 7 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 12 | 21 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 8 | 25 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 40 | 2 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 8 | 6 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 12 | 10 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 40 | 6 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 16 | 8 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 20 | 9 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 24 | 3 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 48 | 3 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Non-responder | 135 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 2 | 4 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 32 | 8 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 4 | 6 Participants |
| DB Placebo ew | Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point | Week 52 | 2 Participants |
Secondary
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 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. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Time frame: Baseline through Week 52
Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR70 response criteria for the first time at each time point is presented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Non-responder | 126 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 2 | 5 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 4 | 5 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 8 | 11 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 12 | 14 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 16 | 15 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 20 | 9 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 24 | 4 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 32 | 9 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 40 | 4 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 48 | 4 Participants |
| DB Adalimumab 20 mg ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 52 | 6 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 52 | 4 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Non-responder | 120 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 20 | 11 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 32 | 8 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 2 | 5 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 16 | 9 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 48 | 6 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 4 | 6 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 24 | 11 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 12 | 16 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 8 | 7 Participants |
| DB Adalimumab 40 mg Eow | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 40 | 4 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 8 | 1 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 12 | 2 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 40 | 2 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 16 | 1 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 20 | 2 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 24 | 2 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 48 | 3 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Non-responder | 177 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 2 | 2 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 32 | 3 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 4 | 3 Participants |
| DB Placebo ew | Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point | Week 52 | 2 Participants |
Other Pre-specified
Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)
Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.
Time frame: Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group
Population: Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat) | < 40 years | 50 participants |
| DB Adalimumab 20 mg ew | Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat) | Between 40 and 64 years | 361 participants |
| DB Adalimumab 20 mg ew | Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat) | Between 65 and 74 years | 117 participants |
| DB Adalimumab 20 mg ew | Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat) | >= 75 years | 25 participants |
Other Pre-specified
Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)
Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.
Time frame: Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group
Population: Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat) | Female | 413 participants |
| DB Adalimumab 20 mg ew | Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat) | Male | 140 participants |
Other Pre-specified
Change From Baseline in Modified Total Sharp X-ray Score at Week 416
Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.
Time frame: Baseline and Week 416
Population: Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Change From Baseline in Modified Total Sharp X-ray Score at Week 416 | 1.16 units on a scale | Standard Deviation 7.969 |
| DB Adalimumab 40 mg Eow | Change From Baseline in Modified Total Sharp X-ray Score at Week 416 | 0.14 units on a scale | Standard Deviation 9.31 |
| DB Placebo ew | Change From Baseline in Modified Total Sharp X-ray Score at Week 416 | 4.83 units on a scale | Standard Deviation 10.012 |
Other Pre-specified
Change From Baseline in Modified Total Sharp X-ray Score at Week 520
Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.
Time frame: Baseline and Week 520
Population: Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Change From Baseline in Modified Total Sharp X-ray Score at Week 520 | 2.60 units on a scale | Standard Deviation 8.822 |
| DB Adalimumab 40 mg Eow | Change From Baseline in Modified Total Sharp X-ray Score at Week 520 | 0.72 units on a scale | Standard Deviation 10.43 |
| DB Placebo ew | Change From Baseline in Modified Total Sharp X-ray Score at Week 520 | 6.18 units on a scale | Standard Deviation 12.071 |
Other Pre-specified
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.
Time frame: Baseline and Week 260
Population: Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260 | -0.56 units on a scale | Standard Deviation 0.62 |
Other Pre-specified
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.
Time frame: Baseline and Week 520
Population: Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab 20 mg ew | Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520 | -0.62 units on a scale | Standard Deviation 0.6 |
Other Pre-specified
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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.
Time frame: Week 260
Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed as observed (without imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260 | 200 Participants |
Other Pre-specified
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260
Patients were responders if they had: \>= 50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 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.
Time frame: Week 260
Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260 | 153 participants |
Other Pre-specified
Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 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.
Time frame: Week 520
Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (without imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520 | 115 participants |
Other Pre-specified
Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520
Patients were responders if they had: \>= 50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 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.
Time frame: Week 520
Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520 | 100 participants |
Other Pre-specified
Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260
Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 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.
Time frame: Week 260
Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260 | 87 participants |
Other Pre-specified
Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520
Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 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.
Time frame: Week 520
Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520 | 78 participants |
Other Pre-specified
Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10
Patients were responders if they had: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=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.
Time frame: Baseline through Week 520
Population: Participants analyzed were intent-to-treat subjects with non-missing response. Analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10 | 159 participants |
Other Pre-specified
Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260
The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.
Time frame: Week 260
Population: Participants analyzed were intent-to-treat with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260 | 205 participants |
Other Pre-specified
Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520
The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.
Time frame: Week 520
Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab 20 mg ew | Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520 | 110 participants |