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Completed

NCT Number: NCT00795574

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

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florida Academic Dermatology Center

Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Sponsors and collaborators

Lead sponsor

Florida Academic Dermatology Centers

Other

Registry information

Official study title

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

Acronym: HS2006

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 21, 2008
Registry last updated
Nov 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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