A Prospective Randomized Open Trial to Assess the Efficiency of Infliximab for Crohn's Patients after Intestinal Resectio

Phase 2

• Conditions: Crohn' s disease

• Registration Number: JPRN-UMIN000004427
• Lead Sponsor: ower GI disease, Hyogo College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-01
• Study Completion: 2012-05-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1.A patient who has had hypersensitivity to infliximab. 2.A patient who has had a surgery for anal lesion (without intestinal resection) as a reason to be involved for this trial. 3.A patient who has abscess lesion(s). 4.A patient who has past and/or present episode of tuberoses infection. 5.A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission rate at 12 months after the start of protocol treatment (Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.)

Secondary Outcome Measures

Name	Time	Method
Evaluation of efficiency: Remission ratios at 24 months (and 60 months, maximum) after start of protocol treatment, Ratio of the protocol continuation, Clinical activity in both the CDAI and IOIBD, IBDQ score, CRP value, etc. Evaluation of safety: Adverse event, Abnormal values in blood test, etc.