efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease

Not Applicable

• Conditions: Cron' s disease

• Registration Number: JPRN-UMIN000032485
• Lead Sponsor: Sakura medical center, Toho university

Brief Summary

At 78 weeks, endoscopic remission was confirmed in 5/16 patients in the AZA group (31.2%) and 7/12 patients in the ADA group (58.3%) (p=0.24) in the intention-to-treat population. In the per-protocol population (19 patients with evaluable images), remission was recorded in 3/9 (33.3%) patients in the AZA and 7/10 (70.0%) in the ADA group.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-08
• Study Completion: 2018-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

stoma without intestinal resection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
endoscopic remission rate of 18 months after surgery

Secondary Outcome Measures

Name	Time	Method
clinical remission rate, negative CRP, trough level of anti-TNF agents, maintenance rate of the therapy, re-surgery rate of 18 months after surgery