Status:
COMPLETED
Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Lead Sponsor:
Abbott
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.
Detailed Description
This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0 through the end of Wee...
Eligibility Criteria
Inclusion
- Adults with stable, moderate to severe hidradenitis suppurativa
- Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy.
- Ability to administer subcutaneous injections
- General good health otherwise
Exclusion
- Prior anti-TNF therapy
- Unstable antibiotic therapy for HS
- Required medication washouts for other HS treatments
- Prior exposure to Tysabri® (natalizumab);
- Recent infection requiring treatment
- Significant medical events or conditions that may put patients at risk for participation
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
- History of cancer, except successfully treated skin cancer
- Recent history of drug or alcohol abuse
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00918255
Start Date
April 1 2009
End Date
November 1 2010
Last Update
May 9 2011
Active Locations (26)
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1
Site Ref # / Investigator 19062
Birmingham, Alabama, United States, 35205
2
Site Ref # / Investigator 18201
Bakerfield, California, United States, 93309
3
Site Ref # / Investigator 18467
Los Angeles, California, United States, 90045
4
Site Ref # / Investigator 18207
San Diego, California, United States, 92103