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| Sponsors and Collaborators: |
Abbott 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 |
| Genetics Home Reference related topics: | ankylosing spondylitis |
| MedlinePlus related topics: | Ankylosing Spondylitis |
| ChemIDplus related topics: | Adalimumab |
| 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 |
| Estimated Enrollment: | 30 |
| 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| Contact: Abbott Japan Clinical Trials Registration Desk | abtj-ctr@abbott.com |
| Japan | |||||
| Recruiting | |||||
| Hokkaido, Japan | |||||
| Recruiting | |||||
| Nagano, Japan | |||||
| Recruiting | |||||
| Saitama, Japan | |||||
| Recruiting | |||||
| Tokyo, Japan | |||||
| Recruiting | |||||
| Kanagawa, Japan | |||||
| Recruiting | |||||
| Aichi, Japan | |||||
| Recruiting | |||||
| Toyama, Japan | |||||
| Recruiting | |||||
| Fukuoka, Japan | |||||
| Recruiting | |||||
| Shiga, Japan | |||||
| Recruiting | |||||
| Osaka, Japan | |||||
| Recruiting | |||||
| Hyogo, Japan | |||||
| Recruiting | |||||
| Hiroshima, Japan | |||||
| Recruiting | |||||
| Kagawa, Japan | |||||
| Recruiting | |||||
| Fukui, Japan | |||||
| Abbott |
| Eisai Limited |
| Abbott Japan Co.,Ltd |
| Study Director: | Shigeki Hashimoto, Ph.D. | Abbott |
More Information
| Responsible Party: | Abbott ( Eiichi Makino ) |
| Study ID Numbers: | M10-239 |
| First Received: | April 24, 2008 |
| Last Updated: | August 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00667355 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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