Study to Assess the Safety and Efficacy of Infliximab to Treat Hidradenitis Suppurtativa
NCT ID: NCT00795574
Last Updated: 2008-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2005-06-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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infliximab
Double blind placebo cross-over
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.
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
Double blind placebo controlled cross-over
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.
Interventions
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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.
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 Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
ALL
Yes
Sponsors
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Florida Academic Dermatology Centers
OTHER
Responsible Party
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Florida Academic Dermatology Centers
Principal Investigators
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Francisco A Kerdel, M.D
Role: PRINCIPAL_INVESTIGATOR
Florida Acadecmic Dermatology Center
Locations
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Florida Academic Dermatology Center
Miami, Florida, United States
Countries
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References
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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. doi: 10.1016/j.jaad.2009.06.050.
Other Identifiers
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HS2006
Identifier Type: -
Identifier Source: org_study_id