Anakinra as a Treatment for Hydradenitis Suppurativa
This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Non-randomized Study Assessing the Efficacy and Tolerability of Fixed-dose Regimen Daily Subcutaneous Anakinra for the Treatment of Moderate to Severe Hidradenitis Suppurativa|
- Modified sartorius score [ Time Frame: Difference in disease severity from baseline will be assessed at the following timepoints: 0, 2, 4, 8, 12, & 16 weeks ] [ Designated as safety issue: No ]To assess the efficacy of anakinra in the treatment of HS as shown by reduction in objective measures (Modified Sartorius Score) and subjective measures (physician and patient global assessment of pain, odor, and discharge).
- Quality of life assessments [ Time Frame: Difference in quality of life from baseline will be measured at the following timepoints: 0, 2, 4, 8, 12, & 16 weeks ] [ Designated as safety issue: No ]To assess changes in health-related quality of life as shown by subjective quality of life indices such as the Dermatology Life Quality Index (DLQI) and the Short Form 36 (SF-36). Also, to assess tolerability of anakinra as a treatment for HS.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Other Name: Kineret[TM]
|Contact: Kieron S Leslie, M.D.||email@example.com|
|Contact: Tien V Nguyen, B.A.||firstname.lastname@example.org|
|United States, California|
|San Francisco General Hospital||Recruiting|
|San Francisco, California, United States, 94110|
|Principal Investigator: Kieron S Leslie, MD|
|Sub-Investigator: Tien V Nguyen, BA|
|Sub-Investigator: Toby Maurer, MD|
|Sub-Investigator: Erin Amerson, MD|
|Sub-Investigator: Maribel Amodo, RN|
|Sub-Investigator: Mike Rosenblum, MD, PhD|
|Sub-Investigator: Shivani Tripathy, MD|
|Principal Investigator:||Kieron S Leslie, M.D.||University of California, San Francisco - Department of Dermatology|