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Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00918255
Recruitment Status : Completed
First Posted : June 11, 2009
Results First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE June 11, 2009
Results First Submitted Date  ICMJE March 2, 2011
Results First Posted Date  ICMJE May 9, 2011
Last Update Posted Date May 9, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
Percentage of Participants Achieving Clinical Response at Week 16 [ Time Frame: Baseline, Week 16 ]
Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
  • PGA [ Time Frame: Week 16 ]
  • Adverse events [ Time Frame: At each study visit until the end of the trial, Week 52 ]
Change History Complete list of historical versions of study NCT00918255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
  • Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16 [ Time Frame: Baseline, Week 16 ]
    Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.
  • Percentage of Participants Achieving Clinical Response at Week 2 [ Time Frame: Baseline, Week 2 ]
    Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
  • Percentage of Participants Achieving Clinical Response at Week 4 [ Time Frame: Baseline, Week 4 ]
    Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
  • Percentage of Participants Achieving Clinical Response at Week 8 [ Time Frame: Baseline, Week 8 ]
    Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
  • Percentage of Participants Achieving Clinical Response at Week 12 [ Time Frame: Baseline, Week 12 ]
    Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
  • Change From Baseline in Modified Sartorius Scale at Week 16 [ Time Frame: Baseline, Week 16 ]
    The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
  • Change From Baseline in Modified Sartorius Scale at Week 52 [ Time Frame: Baseline, Week 52 ]
    The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
  • Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52 [ Time Frame: Baseline, Week 52 ]
    Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
  • PGA [ Time Frame: At each study visit until the end of the trial, week 52 ]
  • Nodule, Fistula and Abcess Improvement [ Time Frame: Throughout Study ]
  • Sartorius Scale [ Time Frame: Week 16, Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Official Title  ICMJE A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Brief Summary This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.
Detailed Description This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0 through the end of Week 15) followed by a 36-week open-label period (Period 2: Weeks 16 through 52). Participants are randomized in a 1:1:1 ratio based on Hurley Stage as stratification factor to receive adalimumab 40 mg every week (qwk), adalimumab 40 mg every other week (eow), or matching placebo during Period 1. During Period 2, participants receive open-label adalimumab 40 mg eow with the option to escalate to 40 mg weekly dosing at Week 28 or Week 31 if the participant has a Physician's Global Assessment of moderate disease or worse (score of greater than or equal to 3). The primary objective of the study is to determine the clinical efficacy and safety of participants with moderate to severe chronic hidradenitis suppurativa (HS) after 16 weeks of treatment. The secondary objective is to evaluate the maintenance of efficacy and continued safety of adalimumab for an additional 36 weeks of treatment. (Note: Hurley Stage is a classification system for skin involvement that is largely based on the presence and extent of abscess formation accompanied by scarring and sinus tracts. Hurley Stages are I [abscess formation without scarring and sinus tracts], II [widely separated recurrent abscesses with scarring and sinus tracts], and III [multiple interconnected abscesses and sinus tracts across entire area]. Randomization in this study was performed using stratification by Hurley Stage [III versus (I or II).) At the present time, Period 1 double-blind data only is provided; additional information will be provided when analysis of open-label Period 2 is completed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • Biological: adalimumab
    Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
    Other Names:
    • ABT-D2E7
    • Humira
  • Drug: Placebo
    Subcutaneous injection using prefilled syringe containing 0.8 milliliters
Study Arms  ICMJE
  • Experimental: Adalimumab 40 mg qwk
    Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
    Intervention: Biological: adalimumab
  • Experimental: Adalimumab 40 mg eow
    Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
    Intervention: Biological: adalimumab
  • Placebo Comparator: Placebo
    Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
    Intervention: Drug: Placebo
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: April 14, 2011)
154
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2009)
150
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with stable, moderate to severe hidradenitis suppurativa
  • Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy.
  • Ability to administer subcutaneous injections
  • General good health otherwise

Exclusion Criteria:

  • Prior anti-TNF therapy
  • Unstable antibiotic therapy for HS
  • Required medication washouts for other HS treatments
  • Prior exposure to Tysabri® (natalizumab);
  • Recent infection requiring treatment
  • Significant medical events or conditions that may put patients at risk for participation
  • Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
  • History of cancer, except successfully treated skin cancer
  • Recent history of drug or alcohol abuse
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 Denmark,   Germany,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00918255
Other Study ID Numbers  ICMJE M10-467
2008-004587-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Okun, Medical Director, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Martin Okun, MD, PhD Abbott
PRS Account Abbott
Verification Date April 2011

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