Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborator:
Amgen
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00333034
First received: May 23, 2006
Last updated: December 4, 2007
Last verified: December 2007
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Purpose
The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: Etanercept |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.
Secondary Outcome Measures:
- The secondary efficacy endpoints will include but not limited to: PASI 50, PASI 75 (at visit other than week 12, PASI 90, PASI score PGA of 0 or 1 (clear or minimal, Patient global assessment of psoriasis, DLQI,
- EQ5D, FACIT-F.
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2006 |
| Study Completion Date: | May 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate Exclusion Criteria: -Previous treatment with etanercept, antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333034
Locations
| Austria | |
| Innsbruck, Austria, 6020 | |
| Belgium | |
| Brussels, Belgium, 1070 | |
| Leuven, Belgium, 3000 | |
| France | |
| Paris, France, 75010 | |
| Paris, France, 75018 | |
| Germany | |
| Bonn, Germany, 53105 | |
| Hamburg, Germany, 20354 | |
| Muenster, Germany, 48149 | |
| Munchen, Germany, 80335 | |
| Regensburg, Germany, 93053 | |
| Hungary | |
| Miskolc, Hungary, 3501 | |
| Szolnok, Hungary, 5400 | |
| Italy | |
| Messina, Italy, 98158 | |
| Novara, Italy, 28100 | |
| Netherlands | |
| Drachten, Netherlands, 9202 NN | |
| Nijmegen, Netherlands, 6525 | |
| Poland | |
| Lodz, Poland, 91-347 | |
| Wroclaw, Poland, 50-368 | |
| Romania | |
| Bucharest, Romania, 11461 | |
| Cluj-Napoca, Romania, 400006 | |
| Spain | |
| La Coruna, Spain, 15006 | |
| Madrid, Spain, 28922 | |
| Sevilla, Spain, 41003 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Amgen
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: | Trial Manager | For Austria, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Belguim, trials-BEL@wyeth.com |
| Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
| Principal Investigator: | Trial Manager | For Germany, medinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Hungary, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Italy, descresg@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 Romania, WVPIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Spain, infomed@wyeth.com |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00333034 History of Changes |
| Other Study ID Numbers: | 0881A6-318 |
| Study First Received: | May 23, 2006 |
| Last Updated: | December 4, 2007 |
| Health Authority: | European Union: European Medicines Agency |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Psoriasis |
Additional relevant MeSH terms:
|
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 21, 2013