5-ASA Withdrawal for Crohn's Disease Remission

(STATIC Trial)

Recruiting at 47 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

334 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug 5-ASA Withdrawal for Crohn's Disease Remission?

Research indicates that 5-aminosalicylic acid (5-ASA) can be effective in preventing relapses of Crohn's disease, especially in patients with a short duration of remission. However, the effectiveness of 5-ASA in maintaining long-term remission is still debated, with some studies showing mixed results. ^{1 2 3 4 5}

Is 5-ASA withdrawal safe for humans?

In a study, one patient stopped taking 5-ASA due to uterine bleeding, but no other significant safety issues were reported. This suggests that 5-ASA is generally safe, though individual reactions can vary. ^{2 3 5 6 7}

How does 5-ASA withdrawal differ from other Crohn's disease treatments?

5-ASA (5-aminosalicylic acid) is often used to maintain remission in Crohn's disease, but its effectiveness is uncertain, especially compared to other treatments like azathioprine. The trial explores the impact of stopping 5-ASA in patients who are in remission, which is unique because it focuses on the potential to discontinue a commonly used drug rather than continuing or starting a new treatment. ^{1 3 5 8 9}

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.

Research Team

Vipul Jairath

Principal Investigator

Western University; London Health Sciences Centre

Gordon Moran, MD

Principal Investigator

University of Nottingham

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Azathioprine withdrawal in patients with Crohn's disease maintained on prolonged remission: a high risk of relapse. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Controlled trial of oral 5-aminosalicylic acid for the prevention of early relapse in Crohn's disease. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Placebo-controlled trial of oral 5-ASA in relapse prevention of Crohn's disease. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Long-term therapy with 5-aminosalicylic acid in Crohn's disease: is it useful? Our four years experience. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

5-aminosalicylates prevent relapse of Crohn's disease after surgically induced remission: systematic review and meta-analysis. [2018]

6. England pubmed.ncbi.nlm.nih.gov

5-Aminosalicylic acid (mesalazine) use in Crohn's disease: a survey of the opinions and practice of Australian gastroenterologists. [2022]

7. England pubmed.ncbi.nlm.nih.gov

5-aminosalicylate maintenance is not superior to no maintenance in patients with newly diagnosed Crohn's disease-A nationwide cohort study. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

Aminosalicylates, thiopurines and methotrexate in inflammatory bowel disease: Is it possible to discontinue the treatment? [2020]

9. England pubmed.ncbi.nlm.nih.gov

The gap between scientific evidence and clinical practice: 5-aminosalicylates are frequently used for the treatment of Crohn's disease. [2018]