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Anakinra as a Treatment for Hydradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT01516749
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : August 6, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE December 7, 2011
First Posted Date  ICMJE January 25, 2012
Results First Submitted Date  ICMJE July 11, 2014
Results First Posted Date  ICMJE August 6, 2014
Last Update Posted Date August 20, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
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 Measures  ICMJE
 (submitted: January 19, 2012)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
  • 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 Measures  ICMJE
 (submitted: January 19, 2012)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anakinra as a Treatment for Hydradenitis Suppurativa
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE 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]
Study Arms  ICMJE Experimental: Anakinra
All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
Intervention: Drug: anakinra
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2012)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01516749
Other Study ID Numbers  ICMJE 11-08101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kieron S Leslie, M.D. University of California, San Francisco - Department of Dermatology
PRS Account University of California, San Francisco
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP