Anakinra as a Treatment for Hydradenitis Suppurativa
|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|
- Change in Modified Sartorius Score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5-10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.
Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.
- Change in Quality of Life Assessments [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).
The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked "What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit?" with a scale of 0=no acitivity to 100=maximal activity.
- Change in Dermatology Quality of Life Index (DLQI) [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life
- Change in C-reactive Protein [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]Change assessed from baseline to end of treatment phase.
|Study Start Date:||October 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||May 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]
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516749
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Kieron S Leslie, M.D.||University of California, San Francisco - Department of Dermatology|