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Stopping Aminosalicylate Therapy in Inactive Crohn's Disease — STATIC  

Crohn Disease Clinical Trial

Official title:
Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial

Clinical Trial Summary

The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.

Clinical Trial Description

Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding their effectiveness for CD. In this open-label, randomized study, participants with CD in remission will be allocated to either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in maintaining CD remission over a 24 month period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03261206
Study type Interventional
Source Alimentiv Inc.
Contact
Status Active, not recruiting
Phase Phase 4
Start date November 20, 2017
Completion date June 2026
View Details
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