Trial record 3 of 3 for:    cimzia and fistula

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
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
  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:


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
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

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 July 26, 2014