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Anakinra as a Treatment for Hydradenitis Suppurativa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01516749
First received: December 7, 2011
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hidradenitis Suppurativa
Drug: anakinra
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 6
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anakinra
All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
Drug: anakinra
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]

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity

Exclusion Criteria:

  1. Use of the following therapies:

    • Etanercept in the 4 weeks prior to the baseline visit (Day 1)
    • Adalimumab in the 8 weeks prior to the baseline visit (Day 1)
    • Infliximab in the 12 weeks prior to the baseline visit (Day 1)
    • Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1)
    • Leflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in the 4 weeks prior to the baseline visit (Day 1)
    • Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)
    • I.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1)
    • 6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)
    • Colchicine, dapsone, mycophenolate mofetil & systemic antibiotics in the 3 weeks prior to the baseline visit (Day 1)
    • Corticosteroids "20mg/day or >0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)
  2. history of immunocompromise including HIV infection
  3. positive Hep B surface antigen -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516749

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kieron S Leslie, M.D. University of California, San Francisco - Department of Dermatology
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01516749     History of Changes
Other Study ID Numbers: 11-08101
Study First Received: December 7, 2011
Results First Received: July 11, 2014
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
hidradenitis suppurativa
anakinra

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Bacterial Infections
Infection
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Suppuration
Sweat Gland Diseases

ClinicalTrials.gov processed this record on November 23, 2014