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Sponsored by: |
Florida Academic Dermatology Centers |
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Information provided by: | Florida Academic Dermatology Centers |
ClinicalTrials.gov Identifier: | NCT00795574 |
A study to assess the safety and efficacy of the IV drug infliximab for the treatment of hidradenitis suppurativa
Condition | Intervention | Phase |
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Hidradenitis Suppurativa |
Drug: infliximab Drug: Placebo Comparator |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study to Assess the Safety and Efficacy of Infliximab for the Treatment of Hidradenitis Suppurativa |
Enrollment: | 38 |
Study Start Date: | June 2005 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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infliximab: Experimental
Double blind placebo cross-over
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Drug: infliximab
Dosing is 5mgs/kg at weeks 0,2 and 6 to complete loading dose of drug and then every 8 weeks thereafter until end of treatment phase.
Drug: Placebo Comparator
5mgs /kg given IV over a minimum of 2 hours at weeks 0,2 and 6 to complete loading dose and then every 8 weeks during maintenance treatment period.
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Placebo: Placebo Comparator
Double blind placebo controlled cross-over
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Drug: Placebo Comparator
5mgs /kg given IV over a minimum of 2 hours at weeks 0,2 and 6 to complete loading dose and then every 8 weeks during maintenance treatment period.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Florida Academic Dermatology Center | |
Miami, Florida, United States, 33143 |
Principal Investigator: | Francisco A Kerdel, M.D | Florida Acadecmic Dermatology Center |
Responsible Party: | Florida Academic Dermatology Centers ( Francisco A Kerdel,M.D. ) |
Study ID Numbers: | HS2006 |
Study First Received: | November 20, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00795574 |
Health Authority: | United States: Food and Drug Administration |
Hidradenitis Suppurativa |
Bacterial Infections Skin Diseases, Infectious Skin Diseases Infliximab Skin Diseases, Bacterial |
Suppuration Hidradenitis Hidradenitis suppurativa Hidradenitis Suppurativa |
Anti-Inflammatory Agents Therapeutic Uses Gastrointestinal Agents Sweat Gland Diseases |
Antirheumatic Agents Infection Dermatologic Agents Pharmacologic Actions |