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Sponsored by: |
Florida Academic Dermatology Centers |
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Information provided by: | Florida Academic Dermatology Centers |
ClinicalTrials.gov Identifier: | NCT00797784 |
A 20 week study to assess the safety and efficacy of etanercept(Enbrel®)for the treatment of Discoid Lupus Erythematosus
Condition | Intervention | Phase |
---|---|---|
Discoid Lupus Erythematosus (DLE) |
Drug: etanercept(Enbrel®) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Open Label Study to Assess the Efficacy and Safety of Etanercept (Enbrel®)for the Treatment of Discoid Lupus Erythematosus |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
And;
Have no history of latent or active TB prior to screening.
Exclusion Criteria:
Contact: Annika M Grant, RN, MBA | 305 324 2110 ext 210 | annika@fadcenter.com |
United States, Florida | |
Florida Academic Dermatology Centers | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Annika M Grant, RN,MBA 305-324-2110 ext 210 annika@fadcenter.com | |
Principal Investigator: Francisco A Kerdel, M.D. |
Responsible Party: | Florida Academic Dermatology Centers ( Francisco A Kerdel,M.D. ) |
Study ID Numbers: | FADC |
Study First Received: | November 21, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00797784 |
Health Authority: | United States: Food and Drug Administration |
Antibodies Autoimmune Diseases Skin Diseases Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous Immunoglobulin G |
Connective Tissue Diseases TNFR-Fc fusion protein Lupus Erythematosus, Discoid Immunoglobulins Cutaneous lupus erythematosus |
Anti-Inflammatory Agents Immunologic Factors Immune System Diseases 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 |