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Sponsored by: |
University of Medicine and Dentistry New Jersey |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00134368 |
The purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.
Condition | Intervention | Phase |
---|---|---|
Vitiligo |
Drug: Etanercept |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot, Investigator-Initiated, Proof-of-Concept, Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo |
Estimated Enrollment: | 40 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | December 2007 |
Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with previous or current exposure to any of the following TNF antagonists:
These patients will not be eligible, even with a wash-out. Patients with previous or current exposure to Kineret will NOT be eligible, even with a wash-out. However, patients with prior or current exposure to biologics directed against T-cells (e.g. alefacept, efalizumab, siplizumab, etc.) will be eligible for enrollment into the study after a wash-out period of 4 weeks before first dose of study drug (baseline visit). It has to be protocol specific also.
United States, New Jersey | |
UMDNJ Psoriasis Center of Excellence | |
New Brunswick, New Jersey, United States, 08903 |
Principal Investigator: | Alice Gottlieb, MD, PhD | UMDNJ-RWJMS |
Study ID Numbers: | 4489 |
Study First Received: | August 22, 2005 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00134368 History of Changes |
Health Authority: | United States: Food and Drug Administration |
vitiligo etanercept |
Anti-Inflammatory Agents Immunologic Factors Skin Diseases Pigmentation Disorders TNFR-Fc fusion protein Vitiligo Immunosuppressive Agents |
Hypopigmentation Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Hypomelanotic Disorder Antirheumatic Agents |
Anti-Inflammatory Agents Immunologic Factors Skin Diseases Pigmentation Disorders Physiological Effects of Drugs Gastrointestinal Agents TNFR-Fc fusion protein Immunosuppressive Agents Vitiligo Pharmacologic Actions |
Hypopigmentation Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |