Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Amgen |
---|---|
Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00111111 |
The purpose of this multicenter, open-label, prospective study is to evaluate the effectiveness and safety of etanercept in the treatment of subjects with psoriasis.
Condition | Intervention | Phase |
---|---|---|
Psoriasis |
Drug: Etanercept |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of Etanercept in the Treatment of Subjects With Psoriasis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Stable, active plaque psoriasis involving greater than or equal to 10% of body surface area (BSA) at screening and baseline Exclusion Criteria: - Any grade 3 or 4 adverse event or infection within 28 days before screening, or between the screening visit and study drug initiation - Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis - Psoralen plus ultraviolet A radiation (PUVA), oral retinoids, cyclosporine, alefacept (Amevive®), efalizumab (Raptiva®), or any other systemic anti-psoriasis therapy within 28 days of study drug initiation - Ultraviolet light B (UVB) therapy, topical steroids, topical vitamin A or D analog preparations, or anthralin within 14 days of study drug initiation (exception: topical steroids, at no higher than moderate strength, are permitted on scalp, axillae, and groin but dose and formulation must remain stable throughout trial) - Prior exposure to any tumor necrosis factor (TNF)-inhibitor, including etanercept - Severe comorbidities - Known history of tuberculosis (TB), or previous positive purified protein derivative (PPD) test
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20030190 |
Study First Received: | May 17, 2005 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00111111 |
Health Authority: | United States: Food and Drug Administration |
Psoriasis |
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 |