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

Hidradenitis Suppurativa Clinical Trial

— HS2006  

Official title:

Phase 2 Study to Assess the Safety and Efficacy of Infliximab for the Treatment of Hidradenitis Suppurativa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795574
• Other study ID #: HS2006
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2008
• Last updated: November 21, 2008
• Start date: June 2005
• Est. completion date: August 2008

Study information

• Verified date: November 2008
• Source: Florida Academic Dermatology Centers
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Florida Academic Dermatology Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Academic Dermatology Centers

Country where clinical trial is conducted

United States,