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

NCT01582568 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2016-02-19

No results posted yet for this study

Summary

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).

Conditions

  • Crohns Disease

Interventions

DRUG

Certolizumab

Certolizumab 200mg-400mg subcutaneous every 2 weeks for 8 weeks.

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY
  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Bincy P. Abraham, MD, MS · Baylor College of Medicine

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582568 on ClinicalTrials.gov