N/A
N=2
Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
Pyoderma Gangrenosum · Crohn's Disease · Ulcerative Colitis · Inflammatory Bowel Disease
Bottom Line
View on ClinicalTrials.gov: NCT00791557 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Infliximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease |
1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00791557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.