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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795574
First Posted: November 21, 2008
Last Update Posted: November 24, 2008
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.
Information provided by:
Florida Academic Dermatology Centers
  Purpose
A study to assess the safety and efficacy of the IV drug infliximab for the treatment of hidradenitis suppurativa

Condition Intervention Phase
Hidradenitis Suppurativa Drug: infliximab Drug: Placebo Comparator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Assess the Safety and Efficacy of Infliximab for the Treatment of Hidradenitis Suppurativa

Resource links provided by NLM:


Further study details as provided by Florida Academic Dermatology Centers:

Enrollment: 38
Study Start Date: June 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: infliximab
Double blind placebo cross-over
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.
Placebo Comparator: Placebo
Double blind placebo controlled cross-over
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795574


Locations
United States, Florida
Florida Academic Dermatology Center
Miami, Florida, United States, 33143
Sponsors and Collaborators
Florida Academic Dermatology Centers
Investigators
Principal Investigator: Francisco A Kerdel, M.D Florida Acadecmic Dermatology Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francisco A Kerdel,M.D., Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier: NCT00795574     History of Changes
Other Study ID Numbers: HS2006
First Submitted: November 20, 2008
First Posted: November 21, 2008
Last Update Posted: November 24, 2008
Last Verified: November 2008

Keywords provided by Florida Academic Dermatology Centers:
Hidradenitis Suppurativa

Additional relevant MeSH terms:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents