EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment (EUS)

This study has been terminated.
(Not enough subjects to reach accrual goals.)
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Joseph Sellin, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01582568
First received: April 19, 2012
Last updated: February 17, 2016
Last verified: February 2016
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment

Resource links provided by NLM:


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.


Enrollment: 1
Study Start Date: June 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Name: Cimzia

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582568

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
UCB Pharma
Investigators
Principal Investigator: Bincy P. Abraham, MD, MS Baylor College of Medicine
  More Information

Responsible Party: Joseph Sellin, 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: February 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 25, 2016