Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
Not Applicable
Completed
- Conditions
- Inflammatory Bowel DiseasePyoderma GangrenosumCrohn's DiseaseUlcerative Colitis
- Interventions
- Registration Number
- NCT00791557
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- Brief Summary
Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum.
This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
Inclusion Criteria
- Must Be ages 18-75
- Must have both inflammatory bowel disease and moderate to severe pyoderma gangrenosum
- Must never have received Infliximab for the treatment of pyoderma gangrenosum
Exclusion Criteria
- Have had any previous treatment with monoclonal antibodies other than infliximab used to treat IBD or antibody fragments.
- Have a history of serious infections
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Infliximab Infliximab Single arm open label IV Infliximab given at weeks 1,2,14,22
- Primary Outcome Measures
Name Time Method The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease Week 26 Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States