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| Sponsor: | University Hospital Case Medical Center |
|---|---|
| Collaborator: |
Centocor, Inc. |
| Information provided by: | University Hospital Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT00791557 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pyoderma Gangrenosum Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease |
Drug: Infliximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Active Control, Single Group Assignment |
| Official Title: | An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum |
| Estimated Enrollment: | 8 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Single arm open label
|
Drug: Infliximab
IV drug given at weeks 1,2,14,22
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kelly Jeffords, CCRC | 216-983-0861 | kelly.jeffords@uhhospitals.org |
| United States, Ohio | |
| University Hospitals Case Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Kelly Jeffords, CCRC 216-983-0861 kell.jeffords@uhhospitals.org | |
| Principal Investigator: Neil J Korman, MD, PhD | |
| Sub-Investigator: Jennifer D Bahner, MD | |
| Principal Investigator: | Neil J Korman, MD.PhD | University Hospitals Case Medical Center |
More Information
| Responsible Party: | University Hospitals Case Medical Center ( Neil Korman, M.D. ) |
| Study ID Numbers: | 06-07-14 |
| Study First Received: | November 13, 2008 |
| Last Updated: | March 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00791557 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Inflammatory Agents Skin Diseases, Vascular Skin Diseases Infliximab Gastrointestinal Diseases Pyoderma Gangrenosum Colonic Diseases Gastrointestinal Agents Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases |
Pharmacologic Actions Digestive System Diseases Therapeutic Uses Crohn Disease Pyoderma Antirheumatic Agents Skin Ulcer Gastroenteritis Dermatologic Agents Colitis |