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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00870467
Recruitment Status : Completed
First Posted : March 27, 2009
Results First Posted : April 5, 2012
Last Update Posted : August 7, 2012
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: Double-blind adalimumab
Drug: Double-blind Placebo
Biological: Open-label Adalimumab
Biological: Open-labelAdalimumabRescue
Enrollment 334
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DB Adalimumab DB Placebo DB Adalimumab/OL Adalimumab DB Placebo/OL Adalimumab DB Adalimumab/RE OL Adalimumab DB Placebo/RE OL Adalimumab
Hide Arm/Group Description 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. 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. Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Period Title: Double-blind
Started 171 163 0 0 0 0
Completed 155 [1] 151 [2] 0 0 0 0
Not Completed 16 12 0 0 0 0
[1]
10 participants who completed 26 weeks received open-label adalimumab 40 mg eow as rescue therapy
[2]
24 participants who completed 26 weeks received open-label adalimumab 40 mg eow as rescue therapy
Period Title: Open-label
Started 0 0 145 127 10 24
Completed 0 0 132 120 5 21
Not Completed 0 0 13 7 5 3
Arm/Group Title DB Adalimumab DB Placebo Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 171 163 334
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants 163 participants 334 participants
54.0  (13.13) 54.0  (13.20) 54.0  (13.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 163 participants 334 participants
Female
144
  84.2%
128
  78.5%
272
  81.4%
Male
27
  15.8%
35
  21.5%
62
  18.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 171 participants 163 participants 334 participants
171 163 334
1.Primary Outcome
Title Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab DB Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 148 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.5  (6.07) 2.4  (3.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DB Adalimumab, DB Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab DB Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 171 163
Measure Type: Number
Unit of Measure: participants
129 92
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DB Adalimumab, DB Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab DB Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 171 163
Measure Type: Number
Unit of Measure: participants
110 63
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DB Adalimumab, DB Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab DB Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 171 163
Measure Type: Number
Unit of Measure: participants
81 37
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DB Adalimumab, DB Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab DB Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 171 163
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.8  (1.63) -1.8  (1.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DB Adalimumab, DB Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab DB Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 171 163
Measure Type: Number
Unit of Measure: participants
52 24
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DB Adalimumab, DB Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of double-blind study drug.
Arm/Group Title DB Adalimumab DB Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 171 163
Measure Type: Number
Unit of Measure: participants
138 117
8.Secondary Outcome
Title Change From Baseline in Modified Total Sharp X-Ray Score at Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab/OL Adalimumab DB Placebo/OL Adalimumab DB Adalimumab/RE OL Adalimumab DB Placebo/RE OL Adalimumab
Hide Arm/Group Description:
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Overall Number of Participants Analyzed 133 120 5 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (6.50) 2.1  (3.25) 9.6  (11.76) 6.8  (9.37)
9.Secondary Outcome
Title Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab/OL Adalimumab DB Placebo/OL Adalimumab DB Adalimumab/RE OL Adalimumab DB Placebo/RE OL Adalimumab
Hide Arm/Group Description:
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Overall Number of Participants Analyzed 133 120 5 21
Measure Type: Number
Unit of Measure: participants
129 113 4 21
10.Secondary Outcome
Title Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab/OL Adalimumab DB Placebo/OL Adalimumab DB Adalimumab/RE OL Adalimumab DB Placebo/RE OL Adalimumab
Hide Arm/Group Description:
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Overall Number of Participants Analyzed 133 120 5 21
Measure Type: Number
Unit of Measure: participants
117 101 2 15
11.Secondary Outcome
Title Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab/OL Adalimumab DB Placebo/OL Adalimumab DB Adalimumab/RE OL Adalimumab DB Placebo/RE OL Adalimumab
Hide Arm/Group Description:
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Overall Number of Participants Analyzed 133 120 5 21
Measure Type: Number
Unit of Measure: participants
87 85 0 10
12.Secondary Outcome
Title Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab/OL Adalimumab DB Placebo/OL Adalimumab DB Adalimumab/RE OL Adalimumab DB Placebo/RE OL Adalimumab
Hide Arm/Group Description:
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Overall Number of Participants Analyzed 133 120 5 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.7  (1.14) -3.7  (1.58) -1.9  (1.22) -3.4  (1.29)
13.Secondary Outcome
Title Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title DB Adalimumab/OL Adalimumab DB Placebo/OL Adalimumab DB Adalimumab/RE OL Adalimumab DB Placebo/RE OL Adalimumab
Hide Arm/Group Description:
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Overall Number of Participants Analyzed 133 120 5 21
Measure Type: Number
Unit of Measure: participants
62 55 0 4
14.Secondary Outcome
Title Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of adalimumab during the study.
Arm/Group Title Any Adalimumab
Hide Arm/Group Description:
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
Overall Number of Participants Analyzed 326
Measure Type: Number
Unit of Measure: participants
289
Time Frame Through Week 26 for all participants who received at least 1 dose of blinded study drug (adalimumab or placebo) or through Week 52 for participants who received any adalimumab (double-blind and/or open-label, including rescue) in addition to methotrexate.
Adverse Event Reporting Description Treatment-emergent adverse events were defined as occurring: 1) through Week 26 for Week 26 completers in blinded phase (or up to 70 days post-last dose for 26-week non-completers who never received any open-label adalimumab, including as rescue) and 2) through Week 52 for those receiving any adalimumab up to 70 days after the last adalimumab dose.
 
Arm/Group Title DB Adalimumab DB Placebo Any Adalimumab
Hide Arm/Group Description 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. 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. Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
All-Cause Mortality
DB Adalimumab DB Placebo Any Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
DB Adalimumab DB Placebo Any Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/171 (4.09%)   4/163 (2.45%)   21/326 (6.44%) 
Cardiac disorders       
Acute myocardial infarction * 1  0/171 (0.00%)  1/163 (0.61%)  0/326 (0.00%) 
Ear and labyrinth disorders       
Vertigo positional * 1  1/171 (0.58%)  0/163 (0.00%)  1/326 (0.31%) 
Eye disorders       
Cataract * 1  0/171 (0.00%)  0/163 (0.00%)  2/326 (0.61%) 
Gastrointestinal disorders       
Colonic polyp * 1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Pancreatitis acute * 1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Hepatobiliary disorders       
Cholangitis acute * 1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Cholecystitis * 1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Infections and infestations       
Enteritis infectious * 1  1/171 (0.58%)  0/163 (0.00%)  1/326 (0.31%) 
Pneumocystis jiroveci pneumonia * 1  0/171 (0.00%)  1/163 (0.61%)  0/326 (0.00%) 
Pneumonia * 1  1/171 (0.58%)  0/163 (0.00%)  4/326 (1.23%) 
Bronchopneumonia * 1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Gastroenteritis * 1  0/171 (0.00%)  0/163 (0.00%)  2/326 (0.61%) 
Injury, poisoning and procedural complications       
Pelvic fracture * 1  1/171 (0.58%)  0/163 (0.00%)  1/326 (0.31%) 
Ulna fracture * 1  1/171 (0.58%)  0/163 (0.00%)  1/326 (0.31%) 
Investigations       
C-reactive protein increased  1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/171 (0.00%)  1/163 (0.61%)  0/326 (0.00%) 
Rheumatoid arthritis * 1  0/171 (0.00%)  1/163 (0.61%)  0/326 (0.00%) 
Systemic lupus erythematosus * 1  0/171 (0.00%)  1/163 (0.61%)  0/326 (0.00%) 
Arthritis * 1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Intervertebral disc protrusion * 1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Pain in extremity * 1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Nervous system disorders       
Facial spasm * 1  1/171 (0.58%)  0/163 (0.00%)  1/326 (0.31%) 
Respiratory, thoracic and mediastinal disorders       
Interstitial lung disease * 1  0/171 (0.00%)  1/163 (0.61%)  1/326 (0.31%) 
Pleurisy * 1  1/171 (0.58%)  0/163 (0.00%)  1/326 (0.31%) 
Organising pneumonia * 1  0/171 (0.00%)  0/163 (0.00%)  1/326 (0.31%) 
Skin and subcutaneous tissue disorders       
Toxic skin eruption * 1  1/171 (0.58%)  0/163 (0.00%)  1/326 (0.31%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
DB Adalimumab DB Placebo Any Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   104/171 (60.82%)   83/163 (50.92%)   277/326 (84.97%) 
Gastrointestinal disorders       
Constipation * 1  4/171 (2.34%)  2/163 (1.23%)  14/326 (4.29%) 
Diarrhoea * 1  5/171 (2.92%)  1/163 (0.61%)  18/326 (5.52%) 
Periodontitis * 1  5/171 (2.92%)  5/163 (3.07%)  9/326 (2.76%) 
Stomatitis * 1  6/171 (3.51%)  15/163 (9.20%)  17/326 (5.21%) 
Dental caries * 1  3/171 (1.75%)  2/163 (1.23%)  9/326 (2.76%) 
Gastritis * 1  2/171 (1.17%)  1/163 (0.61%)  10/326 (3.07%) 
Nausea * 1  2/171 (1.17%)  3/163 (1.84%)  7/326 (2.15%) 
General disorders       
Injection site erythema * 1  5/171 (2.92%)  3/163 (1.84%)  8/326 (2.45%) 
Injection site reaction * 1  10/171 (5.85%)  1/163 (0.61%)  28/326 (8.59%) 
Pyrexia * 1  5/171 (2.92%)  3/163 (1.84%)  8/326 (2.45%) 
Hepatobiliary disorders       
Hepatic function abnormal * 1  14/171 (8.19%)  9/163 (5.52%)  24/326 (7.36%) 
Liver disorder * 1  4/171 (2.34%)  3/163 (1.84%)  9/326 (2.76%) 
Hepatic steatosis * 1  1/171 (0.58%)  0/163 (0.00%)  7/326 (2.15%) 
Infections and infestations       
Bronchitis * 1  4/171 (2.34%)  4/163 (2.45%)  13/326 (3.99%) 
Gastroenteritis * 1  2/171 (1.17%)  4/163 (2.45%)  8/326 (2.45%) 
Nasopharyngitis * 1  26/171 (15.20%)  27/163 (16.56%)  97/326 (29.75%) 
Pharyngitis * 1  2/171 (1.17%)  4/163 (2.45%)  16/326 (4.91%) 
Cystitis * 1  3/171 (1.75%)  1/163 (0.61%)  11/326 (3.37%) 
Herpes zoster * 1  1/171 (0.58%)  1/163 (0.61%)  7/326 (2.15%) 
Upper respiratory tract infection * 1  2/171 (1.17%)  0/163 (0.00%)  7/326 (2.15%) 
Injury, poisoning and procedural complications       
Contusion * 1  3/171 (1.75%)  4/163 (2.45%)  14/326 (4.29%) 
Fall * 1  5/171 (2.92%)  0/163 (0.00%)  15/326 (4.60%) 
Investigations       
Alanine aminotransferase increased  1  13/171 (7.60%)  6/163 (3.68%)  28/326 (8.59%) 
Aspartate aminotransferase increased  1  11/171 (6.43%)  5/163 (3.07%)  22/326 (6.75%) 
Blood cholesterol increased  1  4/171 (2.34%)  0/163 (0.00%)  5/326 (1.53%) 
Liver function test abnormal  1  3/171 (1.75%)  2/163 (1.23%)  8/326 (2.45%) 
White blood cell count decreased  1  3/171 (1.75%)  1/163 (0.61%)  9/326 (2.76%) 
Metabolism and nutrition disorders       
Hyperlipidaemia  1  3/171 (1.75%)  0/163 (0.00%)  7/326 (2.15%) 
Musculoskeletal and connective tissue disorders       
Rheumatoid arthritis * 1  0/171 (0.00%)  4/163 (2.45%)  2/326 (0.61%) 
Back pain * 1  3/171 (1.75%)  3/163 (1.84%)  14/326 (4.29%) 
Nervous system disorders       
Dizziness * 1  1/171 (0.58%)  3/163 (1.84%)  7/326 (2.15%) 
Headache * 1  3/171 (1.75%)  3/163 (1.84%)  12/326 (3.68%) 
Psychiatric disorders       
Insomnia * 1  1/171 (0.58%)  4/163 (2.45%)  5/326 (1.53%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  4/171 (2.34%)  3/163 (1.84%)  7/326 (2.15%) 
Oropharyngeal pain * 1  4/171 (2.34%)  1/163 (0.61%)  9/326 (2.76%) 
Upper respiratory tract inflammation * 1  6/171 (3.51%)  4/163 (2.45%)  28/326 (8.59%) 
Skin and subcutaneous tissue disorders       
Dermatitis contact * 1  1/171 (0.58%)  4/163 (2.45%)  7/326 (2.15%) 
Eczema * 1  6/171 (3.51%)  6/163 (3.68%)  24/326 (7.36%) 
Eczema asteatotic * 1  4/171 (2.34%)  0/163 (0.00%)  4/326 (1.23%) 
Pruritus * 1  4/171 (2.34%)  1/163 (0.61%)  5/326 (1.53%) 
Rash * 1  10/171 (5.85%)  5/163 (3.07%)  26/326 (7.98%) 
Urticaria * 1  0/171 (0.00%)  2/163 (1.23%)  8/326 (2.45%) 
Vascular disorders       
Hypertension * 1  5/171 (2.92%)  8/163 (4.91%)  12/326 (3.68%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00870467    
Other Study ID Numbers: M06-859
First Submitted: March 26, 2009
First Posted: March 27, 2009
Results First Submitted: March 9, 2012
Results First Posted: April 5, 2012
Last Update Posted: August 7, 2012