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Sponsors and Collaborators: |
Florida Academic Dermatology Centers Abbott |
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Information provided by: | Florida Academic Dermatology Centers |
ClinicalTrials.gov Identifier: | NCT00827996 |
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.
Condition | Intervention | Phase |
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Hidradenitis Suppurativa |
Drug: adalimumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Label,Phase Two Study to Assess the Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa |
Enrollment: | 10 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | August 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following:
Exclusion Criteria:
Responsible Party: | Florida Academic Dermatology Centers ( Francisco A Kerdel,M.D ) |
Study ID Numbers: | HIDRI2007 |
Study First Received: | January 21, 2009 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00827996 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Apocrine glands abcesses |
Anti-Inflammatory Agents Bacterial Infections Skin Diseases, Infectious Skin Diseases Skin Diseases, Bacterial Abscess |
Suppuration Hidradenitis Antirheumatic Agents Adalimumab Hidradenitis Suppurativa |
Anti-Inflammatory Agents Bacterial Infections Skin Diseases Hidradenitis Infection Adalimumab Hidradenitis Suppurativa |
Pharmacologic Actions Skin Diseases, Infectious Skin Diseases, Bacterial Therapeutic Uses Suppuration Sweat Gland Diseases Antirheumatic Agents |