Clinical Trial: Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label Assessment of the Efficacy & Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
Brief Summary: The purpose of this study is to determine the effectiveness and safety of efalizumab in treating hydradenitis suppurativa, and to evaluate the duration of the benefit seen in people who respond to treatment with efalizumab, after the medication is stopped.
Detailed Summary: The primary objective of this study is to assess the efficacy of subcutaneously administered efalizumab in the treatment of refractory, severe hydradenitis suppurativa. The secondary objectives of this study are to assess the ability to re-establish disease control after discontinuation of drug and allowance for relapse of disease, as well as to assess the safety of subcutaneously administered efalizumab in the treatment of refractory, severe hydradenitis suppurativa.
Sponsor: New York University School of Medicine
Current Primary Outcome: Reduction in number of inflammatory lesions 12 weeks post-baseline
Original Primary Outcome: Reduction in # of inflammatory lesions 12 wks post baseline
Current Secondary Outcome:
- Time to the reduction of lesions during 12 weeks of treatment
- Percent of disease activity at various weeks after baseline
Original Secondary Outcome:
- Time to the reduction of lesions during 12 wks of treatment
- % of disease activity at various weeks after baseline
Information By: New York University School of Medicine
Dates:
Date Received: August 23, 2005
Date Started: February 2005
Date Completion: August 2006
Last Updated: September 7, 2006
Last Verified: September 2006
