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To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa (HIDRI2007)

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
adalimumab
Sponsored by
Florida Academic Dermatology Centers
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Apocrine glands, abcesses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following:

  1. HS >1 year duration with multiple ER or doctors visits related to HS
  2. Intralesional kenalog injection >5/year, however none within 2 weeks of entry
  3. Failed systemic retinoids, but not within 3 months of entry
  4. Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment)
  5. History of surgery (reconstructive), but not within 3 months of entry

Exclusion Criteria:

  1. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection).
  2. Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
  3. If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection.
  4. Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
  5. Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
  6. Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
  7. Have a concomitant diagnosis or history of congestive heart failure.
  8. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To assess the efficacy and safety of adalimumab in subjects with moderate to severe hidradenitis suppurativa. Efficacy will be evaluated using the included Hidradenitis Suppurativa Severity Index (HSSI).

    Secondary Outcome Measures

    To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa.
    To evaluate the ability of adalimumab to maintain suppression of the disease.

    Full Information

    First Posted
    January 21, 2009
    Last Updated
    January 22, 2009
    Sponsor
    Florida Academic Dermatology Centers
    Collaborators
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00827996
    Brief Title
    To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
    Acronym
    HIDRI2007
    Official Title
    Open Label,Phase Two Study to Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    August 2008 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Florida Academic Dermatology Centers
    Collaborators
    Abbott

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The trial is a 12-week phase 2 study. Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12 in subjects with moderate to severe hidradenitis suppurativa.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hidradenitis Suppurativa
    Keywords
    Apocrine glands, abcesses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    adalimumab
    Intervention Description
    Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12
    Primary Outcome Measure Information:
    Title
    To assess the efficacy and safety of adalimumab in subjects with moderate to severe hidradenitis suppurativa. Efficacy will be evaluated using the included Hidradenitis Suppurativa Severity Index (HSSI).
    Time Frame
    13 weeks
    Secondary Outcome Measure Information:
    Title
    To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa.
    Time Frame
    13 weeks
    Title
    To evaluate the ability of adalimumab to maintain suppression of the disease.
    Time Frame
    13 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following: HS >1 year duration with multiple ER or doctors visits related to HS Intralesional kenalog injection >5/year, however none within 2 weeks of entry Failed systemic retinoids, but not within 3 months of entry Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment) History of surgery (reconstructive), but not within 3 months of entry Exclusion Criteria: Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection). Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent). If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection. Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months. Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening. Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly. Have a concomitant diagnosis or history of congestive heart failure. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francisco A Kerdel, M.D
    Organizational Affiliation
    Florida Academic Dermatology Centers
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa

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