5-ASA Withdrawal for Crohn's Disease Remission

(STATIC Trial)

Not currently recruiting at 52 trial locations

Overseen By Heather MacAulay

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Alimentiv Inc.

Must be taking: Aminosalicylates

Must not be taking: Systemic corticosteroids

Disqualifiers: Ulcerative colitis, Short-bowel syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether people with Crohn's disease can stop taking aminosalicylate, an anti-inflammatory medicine, without worsening their condition. Half of the participants will continue the medication, while the other half will stop, to observe any differences in their condition. Ideal candidates for this trial have had a Crohn's disease diagnosis for at least three months, are currently in remission (symptom-free), and have taken aminosalicylate as prescribed for at least six months. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients, offering valuable insights for those in remission.

Will I have to stop taking my current medications?

Yes, you will need to stop taking aminosalicylates (5-ASA) for the duration of the trial.

What is the safety track record for 5-ASA?

Research has shown that stopping 5-ASA (a type of medication) in people with Crohn’s disease doesn’t increase the risk of serious side effects. One study found that when people stopped 5-ASA while starting a new treatment, they didn’t experience more problems. However, if 5-ASA is the only treatment used, stopping it can lead to more frequent disease recurrence.

Another study found that when people with ulcerative colitis (another bowel disease) stopped taking 5-ASA due to forgetfulness or choice, some experienced a return of symptoms. Still, many did not face additional health issues from stopping the medication.

In summary, while stopping 5-ASA might lead to more disease relapses, it generally appears safe and doesn’t cause extra health problems for many people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores whether patients with Crohn's disease in remission can maintain their health without the continued use of 5-aminosalicylic acid (5-ASA) medications. Most treatments for Crohn's disease involve ongoing medication to manage symptoms and prevent flare-ups. This study investigates the possibility of safely discontinuing 5-ASA, potentially reducing long-term medication use, side effects, and healthcare costs for patients. By understanding the effects of withdrawing 5-ASA, researchers hope to tailor treatment plans more effectively and enhance quality of life for those with Crohn's disease.

What evidence suggests that this trial's treatments could be effective for Crohn's disease remission?

This trial will compare the effects of continuing versus withdrawing 5-ASA in patients with Crohn's disease. Research has shown that stopping 5-ASA, a medication for Crohn's disease, might not lead to more health issues. One study found that when patients stopped 5-ASA and started anti-TNF therapy, a medication that reduces inflammation, it did not increase the risk of health problems. Another analysis showed no extra risk of needing steroids, hospitalization, or surgery after stopping 5-ASA when using biologic treatments. A Cochrane review found that 5-ASA might not be effective in maintaining remission of Crohn's disease symptoms. These findings suggest that stopping 5-ASA might be safe for some people with Crohn's disease. ^{2 4 6 7 8}

Who Is on the Research Team?

Vipul Jairath

Principal Investigator

Western University; London Health Sciences Centre

Gordon Moran, MD

Principal Investigator

University of Nottingham

Are You a Good Fit for This Trial?

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

Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)

I was diagnosed with Crohn's disease over 3 months ago.

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

Exclusion Criteria

I have untreated bile salt issues that might affect the study's tests.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either continue or withdraw 5-ASA therapy to assess non-inferiority in maintaining CD remission

24 months

Follow-up

Participants are monitored for CD-related complications and changes in disease activity and quality of life

24 months

What Are the Treatments Tested in This Trial?

Interventions

• 5-ASA Withdrawal

Trial Overview 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.

How Is the Trial Designed?

Group I: 5-ASA Withdrawal Experimental Treatment 1 Intervention

Half of the subjects will discontinue their aminosalicylate therapy

Group II: 5-ASA Continuation Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Alimentiv Inc.

Lead Sponsor

Trials

15

Recruited

3,300+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials

17

Recruited

1,600+

Citations

1. wjgnet.com wjgnet.com/1007-9327/full/v31/i30/110112.htm

Outcomes of 5-aminosalicylates withdrawal due to non- ... A 10-year cohort study showed that 31% of UC patients who discontinued or did not adhere to 5-ASA therapy developed colorectal cancer, compared ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7015801/

Stopping 5-Aminosalicylate Therapy in Patients With Crohn's ... We found that stopping 5-ASA therapy for patients with CD who were starting anti-TNF therapy did not increase their risk of adverse clinical events.

3. journals.lww.com journals.lww.com/ajg/fulltext/2024/12001/s36_outcome_of_5_aminosalicylate__5_asa_.37.aspx

S36 Outcome of 5-Aminosalicylate (5-ASA) Continuation... The present analysis showed that discontinuing 5-ASA after starting biological therapy was not associated with an increased risk of adverse outcomes in patients ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/apt.15771

Review article: withdrawal of 5‐aminosalicylates in ... It is, however, clear that 5-ASA are ineffective in maintaining remission, with a Cochrane meta-analysis of 2014 patients from 11 studies ...

5. link.springer.com link.springer.com/article/10.1007/s10620-021-07304-8

5-ASAs in Crohn's Disease: Time to Stop the Salicylate? [4] showed that stopping 5-ASA in CD did not increase risk of adverse outcomes (steroid use, hospitalization, or surgery) both in a large US ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12404132/

Outcomes of 5-aminosalicylates withdrawal due to non ... We observed 5-ASA withdrawal due to patient non-adherence in 30 patients (3.4%) in remission out of 880 UC patients, with disease relapse in 12 of them (40.0%).

7. academic.oup.com academic.oup.com/crohnscolitis360/article/7/2/otaf020/8090468

Clinical Outcomes for Patients With Ulcerative Colitis in Cases ... This study investigated the clinical outcomes following JAKi discontinuation and retreatment effectiveness in patients with relapse.

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06878495/efficacy-and-safety-of-discontinuing-5-asa-in-patients-with-inflammatory-bowel-disease

Efficacy and Safety of Discontinuing 5-ASA in Patients With ... This study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator ...