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| Sponsored by: |
Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00245960 |
Purpose
To assess the efficacy of two different treatment regimens of etanercept in psoriasis subjects with psoriatic arthritis with respect to both the skin and joint manifestations.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriatic Arthritis |
Drug: etanercept |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Two-Period Study to Evaluate the Safety and Efficacy of Etanercept on Skin and Joint Disease in Psoriasis Subjects With Psoriatic Arthritis. |
| Estimated Enrollment: | 800 |
| Study Start Date: | December 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Active Comparator |
Drug: etanercept
Group A: Period 1: 50mg BIW. Period 2: 50 mg QW. Group B: Period 1 and 2: 50mg QW.
|
| B: Active Comparator |
Drug: etanercept
Group A: Period 1: 50mg BIW. Period 2: 50 mg QW. Group B: Period 1 and 2: 50mg QW.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 117 Study Locations| Principal Investigator: | Trial Manager | For Argentina, scheima@wyeth.com or rendop@wyeth.com |
| Principal Investigator: | Trial Manager | For Belgium, trials-BEL@wyeth.com |
| Principal Investigator: | Trial Manager | For Denmark, Finland, Sweden, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Germany, medinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Greece, decresg@wyeth.com |
| Principal Investigator: | Trial Manger | For Hungary, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Australia, Korea, Taiwan, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Mexico, gomezlj@wyeth.com |
| Principal Investigator: | Trial Manager | For Netherlands, trials-NL@wyeth.com |
| Principal Investigator: | Trial Manager | For Poland, WPWZMED@wyeth.com |
| Principal Investigator: | Trial manager | For Switzerland, med@wyeth.com |
| Principal Investigator: | Trial Manager | For Turkey, Erisc@wyeth.com |
| Principal Investigator: | Trial Manager | For UK, ukmedinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Austria, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Portugal,Saudi Arabia, clintrialparticipation@wyeth.com |
| Study Director: | Medical Monitor | Wyeth |
| Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
| Principal Investigator: | Trial Manager | For Italy, descresg@wyeth.com |
| Principal Investigator: | Trial Manager | For Spain, infomed@wyeth.com |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 0881A5-401 |
| Study First Received: | October 26, 2005 |
| Last Updated: | July 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00245960 |
| Health Authority: | European Union: European Medicines Agency |
|
Psoriatic Arthritis Skin Disease Joint Disease |
|
Spinal Diseases Skin Diseases Arthritis, Psoriatic Joint Diseases Spondylarthropathy TNFR-Fc fusion protein Bone Diseases |
Musculoskeletal Diseases Psoriasis Arthritis Spondylarthritis Skin Diseases, Papulosquamous Spondylarthropathies |
|
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |
