A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT00647491 |
Recruitment Status :
Completed
First Posted : March 31, 2008
Last Update Posted : March 31, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Biological: adalimumab Biological: placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 352 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | February 2004 |
Actual Primary Completion Date : | June 2005 |
Actual Study Completion Date : | August 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: 20 mg
20 mg adalimumab eow
|
Biological: adalimumab
20 mg sc eow
Other Names:
|
Experimental: 40 mg
40 mg adalimumab eow
|
Biological: adalimumab
40 mg sc eow
Other Names:
|
Experimental: 80 mg
80 mg adalimumab eow
|
Biological: adalimumab
80 mg sc eow
Other Names:
|
Placebo Comparator: Placebo
Placebo eow
|
Biological: placebo
placebo sc eow |
- ACR20 [ Time Frame: Week 24 ]
- ACR20 [ Time Frame: Week12 ]
- ACR50 [ Time Frame: Weeks 12 and 24 ]
- ACR70 [ Time Frame: Weeks 12 and 24 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints.
- Subjects must have failed prior treatment with one or more DMARDs.
- A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
- Body weight less than or equal to 100 kg
Exclusion Criteria:
- A history of, or current, acute inflammatory joint disease of different origin from RA.
- Prior treatment with any TNF antagonist, including adalimumab.
- Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
- Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647491
Japan | |
Aichi, Japan | |
Chiba, Japan | |
Ehime, Japan | |
Fukui, Japan | |
Fukuoka, Japan | |
Gunma, Japan | |
Hokkaido, Japan | |
Hyogo, Japan | |
Ibaraki, Japan | |
Ishikawa, Japan | |
Kagoshima, Japan | |
Kanagawa, Japan | |
Kyoto, Japan | |
Miyagi, Japan | |
Nagano, Japan | |
Nagasaki, Japan | |
Niigata, Japan | |
Okayama, Japan | |
Osaka, Japan | |
Saitama, Japan | |
Shizuoka, Japan | |
Tochigi, Japan | |
Tokushima, Japan | |
Tokyo, Japan | |
Toyama, Japan |
Study Director: | Shigeki Hashimoto, Ph.D. | Abbott |
Responsible Party: | Eiichi Makino, Abbott |
ClinicalTrials.gov Identifier: | NCT00647491 |
Other Study ID Numbers: |
M02-575 |
First Posted: | March 31, 2008 Key Record Dates |
Last Update Posted: | March 31, 2008 |
Last Verified: | March 2008 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |