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| Sponsor: | Abbott |
|---|---|
| Collaborators: |
Eisai Limited Abbott Japan Co.,Ltd |
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00667355 |
Purpose
To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis |
Biological: adalimumab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis |
| Enrollment: | 41 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Adalimumab: Experimental |
Biological: adalimumab
40 mg every other week, subcutaneous
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Japan, Metropolis | |
| Tokyo, Metropolis, Japan | |
| Japan, Prefecture | |
| Hokkaido, Prefecture, Japan | |
| Nagano, Prefecture, Japan | |
| Saitama, Prefecture, Japan | |
| Kanagawa, Prefecture, Japan | |
| Aichi, Prefecture, Japan | |
| Toyama, Prefecture, Japan | |
| Fukuoka, Prefecture, Japan | |
| Shiga, Prefecture, Japan | |
| Osaka, Prefecture, Japan | |
| Hyogo, Prefecture, Japan | |
| Hiroshima, Prefecture, Japan | |
| Kagawa, Prefecture, Japan | |
| Fukui, Prefecture, Japan | |
| Study Director: | Hideyuki Hashiba | Abbott |
More Information
| Responsible Party: | Abbott ( Eiichi Makino ) |
| Study ID Numbers: | M10-239 |
| Study First Received: | April 24, 2008 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00667355 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Ankylosing Spondylitis |
|
Anti-Inflammatory Agents Spinal Diseases Joint Diseases Infection Adalimumab Bone Diseases Pharmacologic Actions Bone Diseases, Infectious Musculoskeletal Diseases |
Therapeutic Uses Arthritis Spondylitis, Ankylosing Antirheumatic Agents Spondylarthritis Spondylitis Spondylarthropathies Ankylosis |