EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment
This study is currently recruiting participants.
Verified April 2012 by Baylor College of Medicine
Sponsor:
Baylor College of Medicine
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Bincy P. Abraham, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01582568
First received: April 19, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
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Purpose
The primary objective of this study is to assess perianal and perirectal fistula healing (complete closure) based on endoscopic ultrasound (EUS) evaluation at 3 months and by PDAI (Pouchitis Disease Activity Index) and Fistula Drainage assessment by 6 months, showing no fistula (new or recurrence) in treatment of Crohn's' disease patient with Certolizumab (Cimzia).
| Condition | Intervention | Phase |
|---|---|---|
|
Crohns Disease |
Drug: Certolizumab |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
Drug Information available for:
Certolizumab pegol
U.S. FDA Resources
Further study details as provided by Baylor College of Medicine:
Primary Outcome Measures:
- The response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]The primary objective of this study is to assess perianal and perirectal fistula healing (complete closure) based on endoscopic ultrasound (EUS) evaluation at 3 months and by PDAI (Pouchitis Disease Activity Index) and Fistula Drainage assessment by 6 months, showing no fistula (new or recurrence) on treatment of Certolizumab (Cimzia) in Crohn's's disease patient s.
Secondary Outcome Measures:
- Fistula healing based on EUS [ Time Frame: 6 months ] [ Designated as safety issue: No ]The secondary objectives: 1. To define an Endoscopic Ultrasound (EUS)-based classification system which will compare and analyze perianal and perirectal fistulizing (abnormal opening between two hollow organs) in Crohn's disease. 2. To compare the EUS classification to PDAI and Fistula Drainage Assessment scores. 3. To determine EUS-based early predictors which can be summarized by the findings/results of the EUS procedure of fistula healing with Certolizumab (Cimzia) treatment.
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Certolizumab
Subjects will take the study drug certolizumab for 8 weeks. They will undergo a endoscopy before study drug and then again after study is complete. The study doctor will be looking for complete closure of the peri-anal fistula identified at visit 1 after the use of certolizumab based on and endoscopic ultrasound (EUS).
|
Drug: Certolizumab
Certolizumab 200mg-400mg subcutaneous every 2 weeks for 8 weeks.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Conventional therapy here indicates non-biologic therapy. Study subjects would have failed conventional and standard regimens of treatment such as immunomodulators (azathioprine, 6-mercaptopurine, methotrexate) or mesalamines or corticosteroids. Certolizumab is actually an approved regimen of treatment for Crohn's disease as patients with perianal fistulas fall under those with moderately to severely active disease. It is not an off-label indication, therefore would not require an IND. The study goal is to look at EUS as a tool to determine how fistula healing occurs with the use of certolizumab which is one of the biologic therapies used to treat fistulizing Crohn's disease. Crohn's disease patients with peri-anal or peri-rectal fistulizing disease. Moderate to severe Crohn's disease patients between the ages of 18 and 70 years with active peri-anal or peri-rectal fistula.
Exclusion Criteria:
- Pre-existing fistula improving on current medical therapy. Contraindication to certolizumab use. Prior use of anti-TNF-alpha.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582568
Contacts
| Contact: Bincy P. Abraham, MD, MS | 713-798-0950 | bincya@bcm.edu |
| Contact: Nichelle P. Nixon | 713-798-7616 | npnixon@bcm.edu |
Locations
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Nichelle P Nixon 713-798-7616 npnixon@bcm.edu | |
| Principal Investigator: Bincy P. Abraham, MD, MS | |
Sponsors and Collaborators
Baylor College of Medicine
UCB, Inc.
Investigators
| Principal Investigator: | Bincy P. Abraham, MD, MS | Baylor College of Medicine |
More Information
No publications provided
| Responsible Party: | Bincy P. Abraham, Principal Investigator, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT01582568 History of Changes |
| Other Study ID Numbers: | H-26958 |
| Study First Received: | April 19, 2012 |
| Last Updated: | April 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Immunoglobulin Fab Fragments Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013