Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.
Detailed description
This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug \[adalimumab or placebo\] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.
Interventions
BIOLOGICALDouble-blind adalimumab
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
BIOLOGICALOpen-label Adalimumab
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
BIOLOGICALOpen-labelAdalimumabRescue
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
Sponsors
Eisai Co., Ltd.
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rheumatoid arthritis based on the American College of Rheumatology criteria * Methotrexate or leflunomide naïve * Disease duration less than or equal to 2 years from diagnosis
Exclusion criteria
* History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV * Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus * Joint surgery involving joints to be assessed within 8 weeks prior to Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 | Baseline, Week 26 | Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Scores were added, giving total mTSS (0 \[normal\] to 380 \[maximal disease\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology) | Week 26 | Patients were ACR50 responders if they had: \>= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders. |
| Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology) | Week 26 | Patients were ACR70 responders if they had: \>= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders. |
| Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26 | Baseline, Week 26 | Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. |
| Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26 | Week 26 | Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score \<2.6 was defined as clinical remission of disease. |
| Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26 | Through Week 26 | Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details. |
| Change From Baseline in Modified Total Sharp X-Ray Score at Week 52 | Baseline, Week 52 | Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Scores were added, giving total mTSS score (0 \[normal\] to 380 \[maximal disease\]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression. |
| Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology) | Week 26 | Patients were ACR20 responders if they had: \>= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders. |
| Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology) | Week 52 | Patients were ACR50 responders if they had: \>=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's 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 ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology) | Week 52 | Patients were ACR70 responders if they had: \>=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein. |
| Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52 | Baseline, Week 52 | Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. |
| Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52 | Week 52 | Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score \<2.6 was defined as clinical remission of disease. |
| Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52 | Through Week 52 | Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details. |
| Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology) | Week 52 | Patients were ACR20 responders if they had: \>=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DB Adalimumab Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. | 171 |
| DB Placebo Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. | 163 |
| Total | 334 |
Baseline characteristics
| Characteristic | DB Adalimumab | DB Placebo | Total |
|---|---|---|---|
| Age Continuous | 54.0 years STANDARD_DEVIATION 13.13 | 54.0 years STANDARD_DEVIATION 13.2 | 54.0 years STANDARD_DEVIATION 13.15 |
| Region of Enrollment Japan | 171 participants | 163 participants | 334 participants |
| Sex: Female, Male Female | 144 Participants | 128 Participants | 272 Participants |
| Sex: Female, Male Male | 27 Participants | 35 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 104 / 171 | 83 / 163 | 277 / 326 |
| serious Total, serious adverse events | 7 / 171 | 4 / 163 | 21 / 326 |
Outcome results
Primary
Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Scores were added, giving total mTSS (0 \[normal\] to 380 \[maximal disease\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Time frame: Baseline, Week 26
Population: All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Analysis performed using observed cases; no imputation technique used. Participants who switched to open-label adalimumab before Week 26 were excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab | Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 | 1.5 units on a scale | Standard Deviation 6.07 |
| DB Placebo | Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 | 2.4 units on a scale | Standard Deviation 3.2 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Time frame: Baseline, Week 26
Population: All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Last observation carried forward (LOCF) was used for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab | Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26 | -2.8 units on a scale | Standard Deviation 1.63 |
| DB Placebo | Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26 | -1.8 units on a scale | Standard Deviation 1.79 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Time frame: Baseline, Week 52
Population: Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab | Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52 | -3.7 units on a scale | Standard Deviation 1.14 |
| DB Placebo | Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52 | -3.7 units on a scale | Standard Deviation 1.58 |
| DB Adalimumab/RE OL Adalimumab | Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52 | -1.9 units on a scale | Standard Deviation 1.22 |
| DB Placebo/RE OL Adalimumab | Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52 | -3.4 units on a scale | Standard Deviation 1.29 |
Secondary
Change From Baseline in Modified Total Sharp X-Ray Score at Week 52
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Scores were added, giving total mTSS score (0 \[normal\] to 380 \[maximal disease\]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.
Time frame: Baseline, Week 52
Population: Participants who completed 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Adalimumab | Change From Baseline in Modified Total Sharp X-Ray Score at Week 52 | 1.6 units on a scale | Standard Deviation 6.5 |
| DB Placebo | Change From Baseline in Modified Total Sharp X-Ray Score at Week 52 | 2.1 units on a scale | Standard Deviation 3.25 |
| DB Adalimumab/RE OL Adalimumab | Change From Baseline in Modified Total Sharp X-Ray Score at Week 52 | 9.6 units on a scale | Standard Deviation 11.76 |
| DB Placebo/RE OL Adalimumab | Change From Baseline in Modified Total Sharp X-Ray Score at Week 52 | 6.8 units on a scale | Standard Deviation 9.37 |
Secondary
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score \<2.6 was defined as clinical remission of disease.
Time frame: Week 26
Population: All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26 | 52 participants |
| DB Placebo | Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26 | 24 participants |
p-value: <0.001Fisher Exact
Secondary
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score \<2.6 was defined as clinical remission of disease.
Time frame: Week 52
Population: Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52 | 62 participants |
| DB Placebo | Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52 | 55 participants |
| DB Adalimumab/RE OL Adalimumab | Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52 | 0 participants |
| DB Placebo/RE OL Adalimumab | Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52 | 4 participants |
Secondary
Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Patients were ACR20 responders if they had: \>= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Time frame: Week 26
Population: All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology) | 129 participants |
| DB Placebo | Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology) | 92 participants |
p-value: <0.001Fisher Exact
Secondary
Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Patients were ACR20 responders if they had: \>=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's 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 52
Population: Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 129 participants |
| DB Placebo | Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 113 participants |
| DB Adalimumab/RE OL Adalimumab | Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 4 participants |
| DB Placebo/RE OL Adalimumab | Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 21 participants |
Secondary
Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Patients were ACR50 responders if they had: \>= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Time frame: Week 26
Population: All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology) | 110 participants |
| DB Placebo | Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology) | 63 participants |
p-value: <0.001Fisher Exact
Secondary
Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Patients were ACR50 responders if they had: \>=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's 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 52
Population: Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 117 participants |
| DB Placebo | Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 101 participants |
| DB Adalimumab/RE OL Adalimumab | Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 2 participants |
| DB Placebo/RE OL Adalimumab | Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 15 participants |
Secondary
Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Patients were ACR70 responders if they had: \>= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Time frame: Week 26
Population: All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology) | 81 participants |
| DB Placebo | Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology) | 37 participants |
p-value: <0.001Fisher Exact
Secondary
Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Patients were ACR70 responders if they had: \>=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus \>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's 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 52
Population: Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 87 participants |
| DB Placebo | Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 85 participants |
| DB Adalimumab/RE OL Adalimumab | Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 0 participants |
| DB Placebo/RE OL Adalimumab | Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology) | 10 participants |
Secondary
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.
Time frame: Through Week 26
Population: All participants who received at least 1 dose of double-blind study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26 | 138 participants |
| DB Placebo | Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26 | 117 participants |
Secondary
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.
Time frame: Through Week 52
Population: Participants who received at least 1 dose of adalimumab during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Adalimumab | Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52 | 289 participants |