NCT03261206

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Alimentiv Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Crohn Disease
• Remission

Interventions

Type	Name	Description
OTHER	5-ASA Withdrawal	Withdrawal of 5-ASA therapy

Timeline

• Start date: 2017-11-20
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2017-08-24
• Last updated: 2025-05-20

Locations

46 sites across 4 countries: Canada, Italy, Ukraine, United Kingdom