Clinical Trial: Anakinra as a Treatment for Hydradenitis Suppurativa

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

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<

Brief Summary: 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.

Detailed Summary:
Sponsor: University of California, San Francisco

Current Primary Outcome: Change in Modified Sartorius Score [ Time Frame: Baseline, 8 weeks ]

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.



Original Primary Outcome: 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 ]

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).


Current Secondary Outcome:

  • Change in Quality of Life Assessments [ Time Frame: Baseline, 8 weeks ]

    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 ]
    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 ]
    Change assessed from baseline to end of treatment phase.


Original Secondary Outcome: 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 ]

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.


Information By: University of California, San Francisco

Dates:
Date Received: December 7, 2011
Date Started: October 2012
Date Completion:
Last Updated: August 15, 2014
Last Verified: August 2014