Study on Treatment of ulcerative colitis with infliximab originator and bio- Similar Targeting remissio

Not Applicable

Recruiting

• Conditions: ulcerative colitis

• Registration Number: JPRN-UMIN000043098
• Lead Sponsor: Sapporo Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-22
• Last Update Posted: 17 October 2023
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients for whom a definitive diagnosis of ulcerative colitis has not been obtained 2. Proctitis type patients 3. Patients who have been administered either IFX / BS1 / BS2 in the past (However, cases in which treatment was discontinued after achieving remission by IFX / BS1 / BS2 treatment are excluded only when the same preparation is restarted due to relapse) 4. Patients who have been treated with adalimumab or golimumab in the past and have been primarily ineffective 5. Patients with a history of colectomy 6. Patients with or have a history of malignant disease 7. Patients with serious infectious diseases 8. Others who are judged by the principal investigator to be inappropriate as research subjects

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission rate 30 weeks after the start of administration in the IFX / BS1 / BS2 groups

Secondary Outcome Measures

Name	Time	Method
1) Remission rate, treatment continuation rate, surgery rate after 2 weeks, 6 weeks, 14 weeks, 22 weeks and 30 weeks 2) Cumulative remission maintenance rate, treatment continuation rate, surgery rate (Kaplanmeier method) 3) Calculation of cross-reactivity of anti-drug antibody against IFX / BS1 / BS2 to other preparations 4) Incidence of adverse events and their contents, presence or absence of abnormal laboratory test values, etc.