To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa (HIDRI2007)

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier:
NCT00827996
First received: January 21, 2009
Last updated: January 22, 2009
Last verified: January 2009

January 21, 2009
January 22, 2009
February 2007
November 2007   (final data collection date for primary outcome measure)
To assess the efficacy and safety of adalimumab in subjects with moderate to severe hidradenitis suppurativa. Efficacy will be evaluated using the included Hidradenitis Suppurativa Severity Index (HSSI). [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00827996 on ClinicalTrials.gov Archive Site
  • To evaluate the role of TNF alpha in the pathogenesis of hidradenitis suppurativa. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the ability of adalimumab to maintain suppression of the disease. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
To Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
Open Label,Phase Two Study to Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa

The trial is a 12-week phase 2 study. Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12 in subjects with moderate to severe hidradenitis suppurativa.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hidradenitis Suppurativa
Drug: adalimumab
Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
August 2008
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following:

  1. HS >1 year duration with multiple ER or doctors visits related to HS
  2. Intralesional kenalog injection >5/year, however none within 2 weeks of entry
  3. Failed systemic retinoids, but not within 3 months of entry
  4. Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment)
  5. History of surgery (reconstructive), but not within 3 months of entry

Exclusion Criteria:

  1. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection).
  2. Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent).
  3. If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection.
  4. Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
  5. Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
  6. Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
  7. Have a concomitant diagnosis or history of congestive heart failure.
  8. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00827996
HIDRI2007
Yes
Francisco A Kerdel,M.D, Florida Academic Dermatology Centers
Florida Academic Dermatology Centers
Abbott
Principal Investigator: Francisco A Kerdel, M.D Florida Academic Dermatology Centers
Florida Academic Dermatology Centers
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP