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

Sponsor
Florida Academic Dermatology Centers
Study ID
NCT00827996
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • adalimumab — DRUG
    Subjects will be given subcutaneous injections at weeks 0 (160mg), 2 (80mg), and then every other week (40mg) until week 12

Study Details

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.

Key Dates

Start date
Feb 28, 2007
Status verified
Jan 2009
Primary completion
Nov 30, 2007
Completion
Aug 31, 2008

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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 ]

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