Lead Investigator: Noah Goldfarb, University of Minnesota
Title of Proposal Research: Decision tool for the use of adalimumab for hidradenitis suppurativa
Vivli Data Request: 7435
Funding Source: None
Potential Conflicts of Interest: Dr. Goldfarb was involved with clinical trials with AbbVie, Chemocentryx and Pfizer. Dr. Goldfarb was on an advisory board for Novartis. He does not have any continued contract with them at this time and therefore have no conflicts to mitigate. Dr. Goldfarb was primary investigator for a new medication for hidradenitis suppurativa. This trial is now completed. He has no other financial conflicts with Abbvie. As the study is now complete, there are no conflicts to mitigate.
Summary of the Proposed Research:
Hidradenitis suppurativa (HS) is a chronic skin disorder affecting the hair follicles. This disease is characterized by inflammatory nodules, abscess and draining tunnels in the body folds. The estimated prevalence of HS globally ranges from 0.1-4%. Currently the only federal drug administration (FDA) approved medication for HS is adalimumab. Unfortunately, only 40-60% of patients respond to adalimumab. We are proposing to develop a novel scoring tool to help differentiate adalimumab responders from non-responders in a clinic setting prior to initiating adalimumab.
Requested Studies:
A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa – PIONEER II
Data Contributor: AbbVie
Study ID: NCT01468233
Sponsor ID: M11-810
A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa – PIONEER I
Data Contributor: AbbVie
Study ID: NCT01468207
Sponsor ID: M11-313