Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC)

Alimentiv

Status and phase

Active, not recruiting

Phase 4

Conditions

Remission

Crohn Disease

Treatments

Other: 5-ASA Withdrawal

Study type

Interventional

Funder types

Other

Identifiers

NCT03261206

RP1610

Details and patient eligibility

About

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.

Full 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.

Enrollment

334 patients

Sex

All

Ages

18+ years old

Volunteers

No 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
History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures
Currently participating in another interventional trial, or previous participation within the last 3 months