Stopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial - STATIC

Alimentiv Inc0 个研究点目标入组 1,580 人开始时间: 2019年6月24日最近更新: 2020年9月21日

适应症

试验速览

暂无简介。

•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

•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.

发起方