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Stopping Aminosalicylate Therapy in Inactive Crohn's Disease | Clinical Trials | Clareo Health

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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

NCT03261206•Alimentiv Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented diagnosis of CD at least 3 months prior to enrollment
•Taking any brand or dosage of an oral aminosalicylate for at least 6 months
•Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)
•CD currently in clinical remission
•Able to participate fully in all aspects of the clinical trial
•Written informed consent obtained and documented

Exclusion Criteria

•A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
•A diagnosis of short-bowel syndrome
•Active perianal disease
•Active fistulizing disease
•A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery
•Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment
•Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment
•Unwillingness to stop taking aminosalicylates for the duration of the trial
•Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment
•Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
+2 more criteria

Locations (46)

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Dr. Jesse Siffledeen Professional Medical Corporation

Edmonton, Alberta, Canada

(G.I.R.I.) GI Research Institute

Vancouver, British Columbia, Canada

Discovery Clinical Services Ltd.

Victoria, British Columbia, Canada

University of Manitoba - Health Sciences Centre

Winnipeg, Manitoba, Canada

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Scott Shulman Medical Professional Corporation

North Bay, Ontario, Canada

Taunton Surgical Center

Oshawa, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

November 20, 2017

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

May 20, 2025

Enrollment

334

ACTUAL participants

Conditions

Crohn DiseaseRemission

Interventions

5-ASA Withdrawal

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

Inclusion Criteria

Exclusion Criteria

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