The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab

Not Applicable

• Conditions: ulcerative colitis

• Registration Number: JPRN-UMIN000007341
• Lead Sponsor: Tohoku University Graduate School of Medicine (Tohoku University Hospital)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-21
• Study Completion: 2015-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Infliximab contraindication 1) Patients with severe infection (Sepsis, etc) 2) Patients with active tuberculosis 3) Patients with history of hypersensitivity to the ingredient of infliximab, or the protein of mouse origin 4) Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5) Patients with congestive heart failure (2) Pregnant or likely to be pregnant women (3) Pregnant or lactating women (4) Patients < 20 years of age (5) Patients not approving the study consent (6) Patients who have ever received anti-TNF antibodies before (7) Patients who have severe obstructive strictures or abdominal abscess assessed by X-ray, abdominal computed tomography, or endoscopy (8) Patients with active hepatitis B or C (9) Patients with human immunodeficiency virus (10) Patients with malignancy (11) Patients in 6 months after surgery (12) Patients judged as inadequate at the discretion of physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission rate at week 54

Secondary Outcome Measures

Name	Time	Method
1) The rate of remission (Mayo score of 0-2, with each individual subscore of 0-1) at week 8 and 30 2) The rate of clinical response (a decrease in the total Mayo score of at least 3 points and at least 30%, with a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1) at week 8, 30 and 54 3) The rate of mucosal healing at week 8, 30 and 54 4) Safety assessment etc.