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

Phase 4
Waitlist Available
Led By Vipul Jairath, MD
Research Sponsored by Alimentiv Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Taking any brand or dosage of an oral aminosalicylate for at least 6 months
CD currently in clinical remission
Must not have
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
A diagnosis of short-bowel syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months prior to enrollment and 24 months after enrollment
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare continuing 5-ASA therapy versus stopping it in Crohn's disease patients who are in remission to see if there is a difference in disease flareups.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated here, potential side effects may include symptoms related to Crohn's Disease flare-ups due to withdrawal of treatment such as abdominal pain, diarrhea, and possibly worsening inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been taking an oral aminosalicylate medication for at least 6 months.
Select...
My Crohn's disease is currently not showing symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had major bowel surgery for Crohn's disease in the last 6 months.
Select...
I have been diagnosed with short-bowel syndrome.
Select...
I have used corticosteroids for over 2 weeks in the last 3 months.
Select...
I am not willing to stop taking aminosalicylates during the trial.
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My Crohn's disease worsened recently, needing more treatment or surgery.
Select...
I have been diagnosed with a form of colitis or diverticular disease.
Select...
I have active issues around my anus.
Select...
I have an active fistula.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months prior to enrollment and 24 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months prior to enrollment and 24 months after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CD-related complications at 2 years
Secondary study objectives
CD-related complications at 1 year
Change in CD-related and total healthcare costs at 2 years
Change in CD-related drug treatment costs at 2 years
+9 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Find a Location

Who is running the clinical trial?

Alimentiv Inc.Lead Sponsor
14 Previous Clinical Trials
2,920 Total Patients Enrolled
Academic Medical Organization of Southwestern OntarioOTHER
15 Previous Clinical Trials
1,099 Total Patients Enrolled
Vipul Jairath, MDPrincipal InvestigatorWestern University; London Health Sciences Centre
2 Previous Clinical Trials
976 Total Patients Enrolled
Gordon Moran, MDPrincipal InvestigatorUniversity of Nottingham

Media Library

5-ASA Withdrawal Clinical Trial Eligibility Overview. Trial Name: NCT03261206 — Phase 4
Crohn's Disease Research Study Groups: 5-ASA Continuation, 5-ASA Withdrawal
Crohn's Disease Clinical Trial 2023: 5-ASA Withdrawal Highlights & Side Effects. Trial Name: NCT03261206 — Phase 4
5-ASA Withdrawal 2023 Treatment Timeline for Medical Study. Trial Name: NCT03261206 — Phase 4
~56 spots leftby Jun 2026
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