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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00235885 |
The purpose of the study is to assess the safety and clinical efficacy of adalimumab in active psoriatic arthritis (PsA) subjects when adalimumab is added to insufficient standard therapy including patients that have failed other TNF therapies
Condition | Intervention | Phase |
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Psoriatic Arthritis |
Drug: adalimumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Adalimumab in Patients With Active Psoriatic Arthritis (PsA) - An Open-Label, Multinational Study to Evaluate the Response to Every-Other Week Adalimumab When Added to Insufficient Standard Therapy, Including Patients Who Failed Prior Treatment With Other TNF-Inhibitors (STEREO) |
Estimated Enrollment: | 445 |
Study Start Date: | July 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | M04-724, EudraCT: 2005/001185-14 |
Study First Received: | October 7, 2005 |
Last Updated: | August 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00235885 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Psoriatic Arthritis adalimumab |
Spinal Diseases Skin Diseases Arthritis, Psoriatic Joint Diseases Spondylarthropathy Adalimumab Bone Diseases |
Musculoskeletal Diseases Psoriasis Arthritis Spondylarthritis Skin Diseases, Papulosquamous Spondylarthropathies |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |