Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00245960
First received: October 26, 2005
Last updated: March 31, 2009
Last verified: March 2009
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
psoriatic arthritis
Drug Information available for:
Etanercept
U.S. FDA Resources
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Efficacy of Two Different Treatment Regimens of Etanercept in Treating Skin Manifestations of Psoriasis Subjects With Psoriatic Arthritis. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 752 |
| 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 |
|---|---|
| Active Comparator: A |
Drug: etanercept
Group A: Period 1: 50mg BIW. Period 2: 50 mg QW. Group B: Period 1 and 2: 50mg QW.
|
| Active Comparator: B |
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 |
Criteria
Inclusion Criteria:
- 18 years of age or older at time of consent
- Active Psoriatic Arthritis
- Clinically stable, plaque psoriasis involving more than 10% of the body surface area
Exclusion Criteria:
- Evidence of skin conditions other than psoriasis that would interfere with skin examinations.
- Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation
- Prior exposure to any TNF-inhibitor, including etanercept
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245960
Show 117 Study Locations
Show 117 Study LocationsSponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| 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 is now a wholly owned subsidiary of Pfizer |
| 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
No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00245960 History of Changes |
| Other Study ID Numbers: | 0881A5-401 |
| Study First Received: | October 26, 2005 |
| Results First Received: | March 31, 2009 |
| Last Updated: | March 31, 2009 |
| Health Authority: | European Union: European Medicines Agency |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Psoriatic Arthritis Skin Disease Joint Disease |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013