An interventional study of Infliximab in Pyoderma Gangrenosum, Crohn's Disease and Ulcerative Colitis, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
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.
36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.
This study's enrollment of 2 is below the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.
Browse Pyoderma Gangrenosum studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
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Exclusion Criteria:
Single arm open label IV Infliximab given at weeks 1,2,14,22
Drug: Infliximab
IV drug given at weeks 1,2,14,22
Also known as: Remicade
The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease
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.
Time frame: Week 26
| Milestone | Infliximab |
|---|---|
| Started | 2 |
| Completed | 1 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
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.
| participants | Infliximab |
|---|---|
| The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease | 1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infliximab | — | 0/2 (0%) | 1/2 (50%) |
| Event | Infliximab |
|---|---|
| Infusion reactionBlood and lymphatic system disorders | 1/2 |
| Bone marrow suppressionBlood and lymphatic system disorders | 1/2 |
| InfectionInfections and infestations | 1/2 |
| Age, Customized(participants) | Infliximab |
|---|---|
| <=18 years | 0 |
| Between 18 and 75 years | 2 |
| >=75 years | 0 |
| Sex: Female, Male(Participants) | Infliximab |
|---|---|
| Female | 0 |
| Male | 2 |
The record gives a start of Oct 2008, a primary completion of Dec 2009 and a completion of Feb 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2013, 3 years 11 months after primary completion.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Infliximab
University Hospitals Cleveland Medical Center →