Clinical Trial: Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER (Open-Label Extension)

Brief Summary: Hidradenitis Suppurativa is a painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring. This Study is an open-label extension study available to subjects who participated in a prior adalimumab study who meet all the inclusion and none of the exclusion criteria. The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe HS.

Detailed Summary: The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe HS. The clinical trial identifier is PIONEER (OPEN-LABEL EXTENSION).
Sponsor: AbbVie (prior sponsor, Abbott)

Current Primary Outcome: Proportion of subjects achieving clinical response [ Time Frame: Baseline (Week 0) up to Week 60 ]

Subjects achieving improvement in hidradenitis suppurativa severity


Original Primary Outcome: Proportion of subjects achieving clinical response. [ Time Frame: Baseline (Week 0) up to Week 60 ]

Subjects achieving improvement in hidradenitis suppurativa severity.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: AbbVie

Dates:
Date Received: March 2, 2012
Date Started: April 2012
Date Completion:
Last Updated: September 26, 2016
Last Verified: September 2016