Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis
Verified date | August 2012 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 334 |
Est. completion date | August 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Site Reference ID/Investigator# 46861 | Anjo | |
Japan | Site Reference ID/Investigator# 46919 | Aomori | |
Japan | Site Reference ID/Investigator# 46805 | Chiba | |
Japan | Site Reference ID/Investigator# 46806 | Chiba | |
Japan | Site Reference ID/Investigator# 46880 | Chiba | |
Japan | Site Reference ID/Investigator# 46881 | Chiba | |
Japan | Site Reference ID/Investigator# 46890 | Fuchu | |
Japan | Site Reference ID/Investigator# 46902 | Fukuoka | |
Japan | Site Reference ID/Investigator# 46903 | Fukuoka | |
Japan | Site Reference ID/Investigator# 46904 | Fukuoka | |
Japan | Site Reference ID/Investigator# 46856 | Gifu | |
Japan | Site Reference ID/Investigator# 46944 | Gunma | |
Japan | Site Reference ID/Investigator# 46893 | Hiroshima | |
Japan | Site Reference ID/Investigator# 46894 | Hiroshima | |
Japan | Site Reference ID/Investigator# 12161 | Hokkaido | |
Japan | Site Reference ID/Investigator# 46916 | Hokkaido | |
Japan | Site Reference ID/Investigator# 46918 | Hokkaido | |
Japan | Site Reference ID/Investigator# 46865 | Hyogo | |
Japan | Site Reference ID/Investigator# 46871 | Hyogo | |
Japan | Site Reference ID/Investigator# 46801 | Ibaraki | |
Japan | Site Reference ID/Investigator# 46925 | Ibaraki | |
Japan | Site Reference ID/Investigator# 46800 | Iwate | |
Japan | Site Reference ID/Investigator# 46873 | Kagoshima | |
Japan | Site Reference ID/Investigator# 46874 | Kagoshima | |
Japan | Site Reference ID/Investigator# 46845 | Kanagawa | |
Japan | Site Reference ID/Investigator# 46899 | Kanagawa | |
Japan | Site Reference ID/Investigator# 46901 | Kanagawa | |
Japan | Site Reference ID/Investigator# 46851 | Kanazawa | |
Japan | Site Reference ID/Investigator# 46852 | Kanazawa | |
Japan | Site Reference ID/Investigator# 46802 | Kawagoe | |
Japan | Site Reference ID/Investigator# 46900 | Kawasaki | |
Japan | Site Reference ID/Investigator# 46875 | Kirishima | |
Japan | Site Reference ID/Investigator# 46870 | Kitakyushu | |
Japan | Site Reference ID/Investigator# 46872 | Kumamoto | |
Japan | Site Reference ID/Investigator# 46912 | Kumamoto | |
Japan | Site Reference ID/Investigator# 46864 | Kyoto | |
Japan | Site Reference ID/Investigator# 46943 | Maebashi | |
Japan | Site Reference ID/Investigator# 46898 | Matsuyama | |
Japan | Site Reference ID/Investigator# 46915 | Miyazaki | |
Japan | Site Reference ID/Investigator# 46853 | Nagano | |
Japan | Site Reference ID/Investigator# 46855 | Nagano | |
Japan | Site Reference ID/Investigator# 46909 | Nagasaki | |
Japan | Site Reference ID/Investigator# 46910 | Nagasaki | |
Japan | Site Reference ID/Investigator# 46911 | Nagasaki | |
Japan | Site Reference ID/Investigator# 46858 | Nagoya | |
Japan | Site Reference ID/Investigator# 46860 | Nagoya | |
Japan | Site Reference ID/Investigator# 46877 | Nara | |
Japan | Site Reference ID/Investigator# 46885 | Nara | |
Japan | Site Reference ID/Investigator# 46848 | Niigata | |
Japan | Site Reference ID/Investigator# 46906 | Niigata | |
Japan | Site Reference ID/Investigator# 46914 | Oita | |
Japan | Site Reference ID/Investigator# 46869 | Okayama | |
Japan | Site Reference ID/Investigator# 46886 | Okayama | |
Japan | Site Reference ID/Investigator# 46887 | Okayama | |
Japan | Site Reference ID/Investigator# 46892 | Okayama | |
Japan | Site Reference ID/Investigator# 46876 | Okinawa | |
Japan | Site Reference ID/Investigator# 46946 | Osaka | |
Japan | Site Reference ID/Investigator# 46947 | Osaka | |
Japan | Site Reference ID/Investigator# 46842 | Rifu | |
Japan | Site Reference ID/Investigator# 46846 | Sagamihara | |
Japan | Site Reference ID/Investigator# 46803 | Saitama | |
Japan | Site Reference ID/Investigator# 46804 | Saitama | |
Japan | Site Reference ID/Investigator# 46878 | Saitama | |
Japan | Site Reference ID/Investigator# 46879 | Saitama | |
Japan | Site Reference ID/Investigator# 46917 | Sapporo | |
Japan | Site Reference ID/Investigator# 46942 | Shimotsuke | |
Japan | Site Reference ID/Investigator# 46854 | Shizuoka | |
Japan | Site Reference ID/Investigator# 46857 | Shizuoka | |
Japan | Site Reference ID/Investigator# 46859 | Shizuoka | |
Japan | Site Reference ID/Investigator# 46895 | Takamatsu | |
Japan | Site Reference ID/Investigator# 46843 | Tokyo | |
Japan | Site Reference ID/Investigator# 46844 | Tokyo | |
Japan | Site Reference ID/Investigator# 46850 | Tokyo | |
Japan | Site Reference ID/Investigator# 46882 | Tokyo | |
Japan | Site Reference ID/Investigator# 46883 | Tokyo | |
Japan | Site Reference ID/Investigator# 46884 | Tokyo | |
Japan | Site Reference ID/Investigator# 46888 | Tokyo | |
Japan | Site Reference ID/Investigator# 46889 | Tokyo | |
Japan | Site Reference ID/Investigator# 46891 | Tokyo | |
Japan | Site Reference ID/Investigator# 46896 | Tokyo | |
Japan | Site Reference ID/Investigator# 46849 | Toyama | |
Japan | Site Reference ID/Investigator# 46907 | Toyama | |
Japan | Site Reference ID/Investigator# 46862 | Toyoake | |
Japan | Site Reference ID/Investigator# 46866 | Toyohashi | |
Japan | Site Reference ID/Investigator# 46863 | Tsu | |
Japan | Site Reference ID/Investigator# 46926 | Tsukuba | |
Japan | Site Reference ID/Investigator# 46897 | Yokohama | |
Japan | Site Reference ID/Investigator# 46905 | Yokohama |
Lead Sponsor | Collaborator |
---|---|
Abbott | Eisai Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Baseline, Week 26 | No |
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. | Week 26 | No |
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. | Week 26 | No |
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. | Week 26 | No |
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. | Baseline, Week 26 | No |
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. | Week 26 | No |
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. | Through Week 26 | Yes |
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. | Baseline, Week 52 | No |
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. | Week 52 | No |
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. | Week 52 | No |
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. | Week 52 | No |
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. | Baseline, Week 52 | No |
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. | Week 52 | No |
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. | Through Week 52 | Yes |
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