5-ASA Withdrawal for Crohn's Disease Remission (STATIC Trial)

Palo Alto (17 mi)

Overseen byGordon Moran, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Alimentiv Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Crohn's Disease who are currently in remission. Participants must have been taking an oral aminosalicylate (5-ASA) for at least 6 months, be compliant with their medication, and able to fully engage in the study. People with active fistulizing disease, recent flares or surgeries, other interventional trials within 3 months, or substance abuse issues cannot join.

Inclusion Criteria

I have been taking an oral aminosalicylate medication for at least 6 months.

My Crohn's disease is currently not showing symptoms.

Exclusion Criteria

I have not had major bowel surgery for Crohn's disease in the last 6 months.

I have been diagnosed with short-bowel syndrome.

I have used corticosteroids for over 2 weeks in the last 3 months.

I am not willing to stop taking aminosalicylates during the trial.

My Crohn's disease worsened recently, needing more treatment or surgery.

I have been diagnosed with a form of colitis or diverticular disease.

I have active issues around my anus.

I have an active fistula.

Treatment Details

The study aims to determine if stopping aminosalicylate therapy (5-ASA withdrawal) is just as effective as continuing it for those in remission from Crohn's Disease. It compares two groups: one stops taking the drug while the other continues its use.

2Treatment groups

Experimental Treatment

Active Control

Group I: 5-ASA WithdrawalExperimental Treatment1 Intervention

Half of the subjects will discontinue their aminosalicylate therapy

Group II: 5-ASA ContinuationActive Control1 Intervention

Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study