Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER (OLE))
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study Protocol M12-555 - PIONEER (Open-Label Extension) A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa|
- Proportion of subjects achieving clinical response. [ Time Frame: Baseline (Week 0) up to Week 60. ] [ Designated as safety issue: No ]Subjects achieving improvement in hidradenitis suppurativa severity.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Prefilled syringe of adalimumab
Other Name: Humira
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).
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|Study Chair:||David Williams, MD||AbbVie|