Study to Assess the Safety and Efficacy of Infliximab to Treat Hidradenitis Suppurtativa (HS2006)

This study has been completed.
Sponsor:
Information provided by:
Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier:
NCT00795574
First received: November 20, 2008
Last updated: November 21, 2008
Last verified: November 2008

November 20, 2008
November 21, 2008
June 2005
August 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00795574 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Assess the Safety and Efficacy of Infliximab to Treat Hidradenitis Suppurtativa
Phase 2 Study to Assess the Safety and Efficacy of Infliximab for the Treatment of Hidradenitis Suppurativa

A study to assess the safety and efficacy of the IV drug infliximab for the treatment of hidradenitis suppurativa

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hidradenitis Suppurativa
  • Drug: infliximab
    Dosing is 5mgs/kg at weeks 0,2 and 6 to complete loading dose of drug and then every 8 weeks thereafter until end of treatment phase.
  • Drug: Placebo Comparator
    5mgs /kg given IV over a minimum of 2 hours at weeks 0,2 and 6 to complete loading dose and then every 8 weeks during maintenance treatment period.
  • Experimental: infliximab
    Double blind placebo cross-over
    Interventions:
    • Drug: infliximab
    • Drug: Placebo Comparator
  • Placebo Comparator: Placebo
    Double blind placebo controlled cross-over
    Intervention: Drug: Placebo Comparator
Grant A, Gonzalez T, Montgomery MO, Cardenas V, Kerdel FA. Infliximab therapy for patients with moderate to severe hidradenitis suppurativa: a randomized, double-blind, placebo-controlled crossover trial. J Am Acad Dermatol. 2010 Feb;62(2):205-17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Person must have moderate to severe Hidradenitis suppurativa
  • Multiple ER or doctors visits related to HS
  • Intralesional kenalog injection >5/year, but none within 3 months of entry
  • HS >1 year duration
  • 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 3 months of entry to the study (excluding the recommended antibiotic regimen given immediately before randomization for evidence of active infection
  • 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 infusion (this includes father's who plan on fathering a child within 6 months after their last infusion
  • Known allergy against infliximab
  • Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
  • Have had any previous treatment with monoclonal antibodies or antibody fragments.
  • Have a known history of serious infections (eg, hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
  • Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
  • Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section 26 on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules.
  • Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
  • Currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
  • Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795574
HS2006
Yes
Francisco A Kerdel,M.D., Florida Academic Dermatology Centers
Florida Academic Dermatology Centers
Not Provided
Principal Investigator: Francisco A Kerdel, M.D Florida Acadecmic Dermatology Center
Florida Academic Dermatology Centers
November 2008

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