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| Sponsors and Collaborators: |
Katholieke Universiteit Leuven Foundation for Scientific Research Flanders |
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| Information provided by: | Katholieke Universiteit Leuven |
| ClinicalTrials.gov Identifier: | NCT00639821 |
Purpose
The aim of this study is to identify mucosal gene signatures predictive of response to infliximab in patients with inflammatory bowel disease using high-density oligonucleotide arrays.
| Condition |
|---|
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Prediction of Response |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Mucosal Gene Signatures to Predict Response to Infliximab in Patients With Inflammatory Bowel Disease. |
Colonic mucosal biopsies from patiens with inflammatory bowel disease refractory to corticosteroids and/or immunosuppression
| Enrollment: | 43 |
| Study Start Date: | July 2004 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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IBD
Patients with refractory inflammatory bowel disease (ulcerative colitis and Crohn's disease) before and after treatment with infliximab.
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Infliximab (IFX) is an effective treatment for Crohn's disease and ulcerative colitis (UC) patients not responding to standard therapy. 30-40% of patients do not improve and response is often incomplete. The aim of this study is to identify mucosal gene signatures predictive of response to IFX using high-density oligonucleotide arrays. Forty-three patients with inflammatory bowel disease, 19 with Crohn's colitis and 24 with UC, undergo a colonoscopy with biopsies before and 4 to 6 weeks after the first IFX treatment. Response to IFX is defined as endoscopic and histologic healing. Total RNA was isolated from pre-IFX biopsies, labelled and hybridized to Affymetrix HGU133plus2.0 Array. Microarray data were analyzed using Bioconductor software. Quantitative real time RT-PCR and immunohistochemistry were used to confirm microarray data.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Colonic mucosal biopsies from patients with refractory inflammatory bowel disease who had never been treated with biological therapy.
Inclusion Criteria:
Exclusion Criteria:
-
Contacts and Locations| Belgium | |
| Department of Gastroenterology | |
| Leuven, Belgium, 3000 | |
| Study Director: | Paul Rutgeerts, MD, PhD | University of Leuven |
More Information
| Responsible Party: | University of Leuven ( Paul Rutgeerts, MD, PhD ) |
| Study ID Numbers: | Array study IBD 1 |
| Study First Received: | March 14, 2008 |
| Last Updated: | March 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00639821 History of Changes |
| Health Authority: | European Union: European Medicines Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
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Microarray Inflammatory bowel disease Infliximab |
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Anti-Inflammatory Agents Digestive System Diseases Infliximab Gastrointestinal Diseases |
Inflammatory Bowel Diseases Antirheumatic Agents Gastroenteritis Intestinal Diseases |
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Anti-Inflammatory Agents Digestive System Diseases Infliximab Gastrointestinal Diseases Therapeutic Uses Gastrointestinal Agents |
Inflammatory Bowel Diseases Antirheumatic Agents Gastroenteritis Intestinal Diseases Dermatologic Agents Pharmacologic Actions |
