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

NCT00795574 | Completed Phase 2 DMC

• 1 other identifier: HS2006
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa

Study Arms (2)

infliximab

EXPERIMENTAL

Double blind placebo cross-over

Drug: infliximab; Drug: Placebo Comparator

Placebo

PLACEBO COMPARATOR

Double blind placebo controlled cross-over

Drug: Placebo Comparator

Interventions

infliximab DRUG

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.

infliximab

Placebo Comparator DRUG

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; infliximab

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida Academic Dermatology Centers: lead

Study Sites (1)

Florida Academic Dermatology Center

Miami, Florida, 33143, United States

Location

Related Publications (1)

• 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.

  PMID: 20115947 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Francisco A Kerdel, M.D

  Florida Acadecmic Dermatology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: June 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 24, 2008

Record last verified: 2008-11

Locations

US (1)