Suspended

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

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What is being tested

5-ASA Withdrawal

Other
Who is being recruted

Crohn Disease+3

+ Digestive System Diseases

+ Gastroenteritis

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Phase 4
Interventional
Study Start: November 2017
See protocol details

Summary

Principal SponsorAlimentiv Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 20, 2017

Actual date on which the first participant was enrolled.

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.

Official TitleStopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial
NCT03261206
Principal SponsorAlimentiv Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

334 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

6 inclusion criteria required to participate
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
Show More Criteria
12 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Half of the subjects will discontinue their aminosalicylate therapy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 46 locations

Suspended

University of Calgary

Calgary, CanadaOpen University of Calgary in Google Maps
Suspended

University of Alberta

Edmonton, Canada
Suspended

Dr. Jesse Siffledeen Professional Medical Corporation

Edmonton, Canada
Suspended

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

Vancouver, Canada
Suspended46 Study Centers