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Sponsors and Collaborators: |
Amgen Wyeth |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00111449 |
The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.
Condition | Intervention | Phase |
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Psoriasis |
Drug: Etanercept |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis |
Estimated Enrollment: | 600 |
Study Start Date: | June 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20030117 |
Study First Received: | May 20, 2005 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00111449 |
Health Authority: | United States: Food and Drug Administration |
Psoriasis, adults skin, Phase 3 clinical trial, Amgen etanercept, Enbrel® moderate, severe |
Skin Diseases Psoriasis TNFR-Fc fusion protein Skin Diseases, Papulosquamous |
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 |