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5-ASA Withdrawal for Crohn's Disease Remission (STATIC Trial)
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months prior to enrollment and 24 months after enrollment
Awards & highlights
STATIC 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.Check my eligibility
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.See study design
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.
STATIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been taking an oral aminosalicylate medication for at least 6 months.
Select...
My Crohn's disease is currently not showing symptoms.
STATIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months prior to enrollment and 24 months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months prior to enrollment and 24 months after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CD-related complications at 2 years
Secondary outcome measures
CD-related complications at 1 year
CD-related or CD-treatment related hospitalizations at 1 year
CD-related or CD-treatment related hospitalizations at 2 years
+20 moreSTATIC 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
12 Previous Clinical Trials
2,917 Total Patients Enrolled
Academic Medical Organization of Southwestern OntarioOTHER
13 Previous Clinical Trials
969 Total Patients Enrolled
Vipul Jairath, MDPrincipal InvestigatorWestern University; London Health Sciences Centre
2 Previous Clinical Trials
964 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have untreated bile salt issues that might affect the study's tests.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.I was diagnosed with Crohn's disease over 3 months ago.I have been taking an oral aminosalicylate medication for at least 6 months.My Crohn's disease is currently not showing symptoms.My Crohn's disease worsened recently, needing more treatment or surgery.I can fully participate in all parts of the clinical trial.I have been diagnosed with a form of colitis or diverticular disease.I have active issues around my anus.I have an active fistula.
Research Study Groups:
This trial has the following groups:- Group 1: 5-ASA Continuation
- Group 2: 5-ASA Withdrawal
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many sites have been selected to oversee this research endeavor?
"This research project is currently enrolling individuals at London Health Sciences Centre - University Hospital in London, Ontario, Taunton Surgical Center in Oshawa, Alberta, and Dr. Jesse Siffledeen Professional Medical Corporation in Edmonton, British Columbia as well as 8 further locations."
Answered by AI
Are there any associated risks with ceasing 5-ASA use?
"The data available indicates that 5-ASA Withdrawal has a score of 3 on the safety scale, as it is currently in Phase 4 and thus approved for clinical use."
Answered by AI
Is this experiment presently enrolling participants?
"Clinicaltrials.gov indicates that this research is actively recruiting participants, which was first published on November 20th 2017 and most recently updated on April 1st 2021."
Answered by AI
What is the upper limit of participants enrolled in this clinical trial?
"Affirmative. The information on clinicaltrials.gov states that the trial is currently recruiting participants, beginning with the first post made on November 20th 2017 and recently edited April 1st 2021. This study seeks to enroll 1580 people from 8 different sites."
Answered by AI
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