ORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile

Region Örebro län0 个研究点目标入组 250 人开始时间: 2024年5月31日最近更新: 2024年6月3日

试验速览

暂无简介。

•To be included in the study, the study subject must meet the following criteria:
•UC or CD diagnosed within < 4 weeks using standard endoscopic, histologic or radiological criteria (ECCO Criteria) Histology report may not be available at baseline.
•Naïve to immunomodulators, biologics and small molecules, i.e. JAK-inhibitors
•Aged 18-70 years old.
•Is considered eligible according to tuberculosis (TB) screening criteria.
•Written informed consent to participate in the study
•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 220
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Study subjects may not be included in the study if any of the following criteria are met:
•A previous known diagnosis of Crohn’s disease, ulcerative colitis or IBD-U, since >6 weeks before baseline
•Unable to provide informed consent
•Unable to comply with protocol requirements (e.g. for reasons including alcohol and/or recreational drug abuse)
•Ongoing sepsis
•Acute obstructive symptoms AND evidence of a fixed stricture on radiology or colonoscopy, which suggest that the patient is in need of surgery over the following year. N.B. patients with modest degrees of stricturing on imaging but no obstructive symptoms may be included according to clinician judgement
•Contra-indications to trial medications including a history of hepatitis B or C, tuberculosis, Cardiac failure, NYHA III-IV
•History of malignancy
•Other serious medical or psychiatric illness
•Previous exposure to a biologic agent

发起方