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5-ASA Withdrawal for Crohn's Disease

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, United KingdomCrohn's Disease+1 More5-ASA Withdrawal - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Crohn's Disease
  • Remission

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

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Study Objectives

1 Primary · 23 Secondary · Reporting Duration: 12 months prior to enrollment and 24 months after enrollment

12 months
CD-related complications at 1 year
CD-related or CD-treatment related hospitalizations at 1 year
CD-related or CD-treatment related surgeries at 1 year
Change in disease activity at 12 months
Other CD-related or CD-treatment related complications at 1 year
Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year
Month 24
Change in CD-related and total healthcare costs at 2 years
Change in CD-related drug treatment costs at 2 years
24 months
CD-related complications at 2 years
CD-related or CD-treatment related hospitalizations at 2 years
CD-related or CD-treatment related surgeries at 2 years
Disease
Other CD-related or CD-treatment related complications at 2 years
Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years
6 months
Change in disease activity at 6 months
Month 12
Change in C-reactive protein concentration at 1 year
Change in fecal calprotectin concentration at 1 year
Change in self-assessed quality of life at 1 year
Month 24
Body Weight Changes
Change in fecal calprotectin concentration at 2 years
Change in self-assessed quality of life at 2 years
Month 6
Body Weight Changes
Change in self-assessed quality of life at 6 months
up to 24 months
Time to first CD-related complication

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
15ml of ExoFlo at Day 0, 2, 4 Week 2, 6, and every 8 weeks after that to week 46
1
15ml of ExoFlo at Day 0, 2, 4, Week 2, Week 6, and every 8 weeks after that to week 46
1
Remestemcel-L

Trial Design

2 Treatment Groups

5-ASA Continuation
1 of 2
5-ASA Withdrawal
1 of 2

Active Control

Experimental Treatment

1580 Total Participants · 2 Treatment Groups

Primary Treatment: 5-ASA Withdrawal · No Placebo Group · Phase 4

5-ASA Withdrawal
Other
Experimental Group · 1 Intervention: 5-ASA Withdrawal · Intervention Types: Other
5-ASA ContinuationNoIntervention Group · 1 Intervention: 5-ASA Continuation · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months prior to enrollment and 24 months after enrollment

Who is running the clinical trial?

Alimentiv Inc.Lead Sponsor
8 Previous Clinical Trials
1,968 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
1 Previous Clinical Trials
660 Total Patients Enrolled
Gordon Moran, MDPrincipal InvestigatorUniversity of Nottingham

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been taking a type of medication called oral aminosalicylate for at least 6 months.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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