Combined therapy of infliximab with surgery in maintenance of remission in Crohn's disease

Phase 4

• Conditions: Crohn' s disease

• Registration Number: JPRN-UMIN000002604
• Lead Sponsor: Clinical Research Group of inflammatory bowel disease in Japan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-01
• Study Completion: 2014-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria include 1) 3 or more surgeries in the past, 2) presence of the stoma, 3) multiple anastomosis, 4) 4 or more strictureplasties, or 5) other types of strictureplasty excepting Heineke-Mickulicz type. A patient is also excluded when doctors in charge of the patient consider that exclusion of the patient is preferable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presense or absense of endoscopic recurrence at the anastomotic site after 24 months.

Secondary Outcome Measures

Name	Time	Method
Endoscopic grade evaluated with Rutgeerts's grading scale after 24 months. Crohn's disease activity index point after 24 months.