The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 15
- 主要终点
- Clinical and endoscopic remission
研究概览
简要总结
Purpose:
To demonstrate that personalised therapy can be delivered to patients with IBD, by treating patients with an increased risk of poor disease course, defined by a serum protein signature at diagnosis, with a top-down treatment, and that this treatment strategy improves clinical outcomes.
Objectives:
Primary objective: To assess if a top-down treatment can improve treatment outcomes in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis.
Secondary objective: To assess if a top-down treatment can improve quality of life and health resource allocation in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis.
Study design:
A multi-centre, biomarker-stratified open-label controlled trial, where newly diagnosed IBD patients are randomised (1:1) to a group with access to the protein signature or a group without access to the protein signature. Study subjects within the protein signature arm who display a high-risk protein profile, will be treated according to a top-down treatment algorithm (anti-TNF agent with/without an immunomodulatory) and subjects without access to the protein signature will be treated according to current clinical practice.
Study population:
Newly diagnosed IBD patients.
Number of subjects: 300
Primary variables:
Composite of both corticosteroid-free clinical remission and endoscopic remission at Week 52, defined as below. Surgery because of IBD during follow-up will be defined as treatment failure.
Ulcerative colitis;
- Clinical remission per patient reported Mayo: A stool frequency subscore (SFS) ≤ 1, and not greater than baseline, and a rectal bleeding subscore (RBS) of 0.
- Endoscopic remission: An endoscopic Mayo subscore of 0 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g
Crohn's disease;
- Clinical remission: An average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
- Endoscopic remission: SES-CD≤2 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 or hypersensitivity. Hypersenstitivity to a thiopurine agent should alert the prescriber to probable hypersensitivity to other thiopurines.
- •History of malignancy
- •Pregnancy at baseline
- •Other serious medical or psychiatric illness
研究组 & 干预措施
Access to protein profile
干预措施: Top down treatment if patient at high risk (Drug)
结局指标
主要结局
Clinical and endoscopic remission
时间窗: Week 52
Composite of proportion of subjects with both corticosteroid-free clinical remission and endoscopic remission at Week 52. Surgery because of IBD during follow-up will be defined as treatment failure.
次要结局
- Clinical/Endoscopy remission and response(Week 52)