Clinical Trial: To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open Label,Phase Two Study to Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
Brief Summary: The trial is a 12-week phase 2 study. Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12 in subjects with moderate to severe hidradenitis suppurativa.
Detailed Summary:
Sponsor: Florida Academic Dermatology Centers
Current Primary Outcome: To assess the efficacy and safety of adalimumab in subjects with moderate to severe hidradenitis suppurativa. Efficacy will be evaluated using the included Hidradenitis Suppurativa Severity Index (HSSI). [ Time Frame: 13 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa. [ Time Frame: 13 weeks ]
- To evaluate the ability of adalimumab to maintain suppression of the disease. [ Time Frame: 13 weeks ]
Original Secondary Outcome: Same as current
Information By: Florida Academic Dermatology Centers
Dates:
Date Received: January 21, 2009
Date Started: February 2007
Date Completion: August 2008
Last Updated: January 22, 2009
Last Verified: January 2009
