An investigational study to assess the safety and effectiveness of continuing existing 5-ASA medication versus stopping it.

Phase 1

• Conditions: Inactive Crohn’s Disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-001382-17-GB
• Lead Sponsor: Alimentiv Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-24
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1580

Inclusion Criteria

1. Aged 18 years or older in primary or secondary care.
2. Documented diagnosis of CD previously confirmed by endoscopy and histology at least 3 months prior to enrollment.
3. Taking any brand or dosage of an oral aminosalicylate for at least 6 months prior to enrollment.
4. Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses).
5. CD currently in clinical remission, defined as:
a. An HBI score = 4 at enrollment visit AND
b. No escalation in medication for the treatment of a CD flare within 3 months prior to enrollment AND
c. No use of systemic corticosteroids for CD (2 continuous weeks or more) within the 3 months prior to enrollment AND
d. Clinician judgement of disease remission.
6. Able to participate fully in all aspects of the clinical trial.
7. Written informed consent obtained and documented.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis.
2. A diagnosis of short-bowel syndrome.
3. Active perianal disease (note: a history of perianal disease is permitted).
4. Active fistulizing disease (note: a history of fistulizing disease is permitted).
5. A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery.
6. Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment.
7. 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.
8. Unwillingness to stop taking aminosalicylates for the duration of the trial.
9. Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment.
10. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participants ability to participate fully in the study.
11. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified