Clinical Trial: A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa

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

Official Title: A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)

Brief Summary: The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.

Detailed Summary: An open label prospective study is performed to investigate the effectiveness and safety of ustekinumab in hidradenitis suppurativa. Twenty patients will be included. They will receive ustekinumab 45 or 90 mg on weeks 0-4-16-28. Patients will be followed up untill week 40.
Sponsor: University Medical Center Groningen

Current Primary Outcome: Change in Sartorius score [ Time Frame: 76 weeks ]

Clinical response is defined as an improvement of the Sartorius score of at least 50%


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Medical Center Groningen

Dates:
Date Received: August 7, 2012
Date Started: May 2012
Date Completion:
Last Updated: February 12, 2015
Last Verified: February 2015