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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier:
NCT00827996
First received: January 21, 2009
Last updated: January 22, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Hidradenitis Suppurativa
 Drug: adalimumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label,Phase Two Study to Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Florida Academic Dermatology Centers:

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). [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the ability of adalimumab to maintain suppression of the disease. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: February 2007
Estimated Study Completion Date: August 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: adalimumab
    Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827996

Sponsors and Collaborators
Florida Academic Dermatology Centers
Abbott
Investigators
Principal Investigator: Francisco A Kerdel, M.D Florida Academic Dermatology Centers
  More Information

No publications provided

Responsible Party: Francisco A Kerdel,M.D, Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier: NCT00827996     History of Changes
Other Study ID Numbers: HIDRI2007
Study First Received: January 21, 2009
Last Updated: January 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Florida Academic Dermatology Centers:
Apocrine glands
abcesses

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
 Infection
Suppuration
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013