2024-514964-24-00招募中3 期
FirST lines of biologics in pAtients with ulceRaTivE colitis: a Randomised controlled trial
University Hospital Of Clermont-Ferrand34 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 34
- 主要终点
- Remission (composite criteria) = no rectal bleeding, normalization of bowel habits (Mayo sub-score of stool frequency = 0) AND faecal calprotectin < 150 µg/g AND no steroids. Remission will be assessed as a binary criterion (yes/no) each month (i.e. 4 weeks-period) between week 4 and week 52, the month being considered as the statistical unit and not the patient.
研究概览
简要总结
To compare strategies starting with the use of anti-integrins (vedolizumab), JAK inhibitors (filgotinib), anti-IL12/23 (ustekinumab) or anti-TNF agents (infliximab) as first line of advanced therapy to maintain remission in patients with ulcerative colitis.
研究设计
- 分配方式
- Randomized
- 主要目的
- FirST lines of biologics in pAtients with ulceRaTivE colitis: a Randomised controlled trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female patients (using effective contraception and a negative pregnancy test for women of childbearing age) diagnosed with UC for at least 3 months
- •Age ≥ 18 years and ≤ 65 years
- •Moderate to severe UC according to modified Mayo score (from 5 to 9)
- •With endoscopic Mayo score ≥ 2
- •With an inadequate response, failure, loss of response, or intolerance to 5-ASA, steroids, or immunosuppressants.
- •Patient capable of giving consent
- •Patient covered by the French healthcare system
排除标准
- •Usual contra-indication to infliximab, filgotinib, vedolizumab or ustekinumab
- •Prior exposure to other biologics or experimental drug
- •No health insurance
- •Pregnant or lactating women : a pregnancy test will be performed for women of childbearing age
- •Patients already included in biomedical research other than an observational study (e.g: registry, cohort)
- •Concomitant Clostridioides difficile infection
- •HIV infection
- •Patient who does not master the French language
- •Patient under guardianship, curatorship or safeguard of justice
- •Steroids > 20 mg/day within two weeks before inclusion
- •Low proctitis (disease limited to the rectum with an extent < 5 cm)
- •Prior history of thromboembolism events
- •Prior history of major cardiovascular problems (such as heart attack or stroke)
- •Long-standing smokers (> 40 pack years)
- •Crohn's disease
- •Stoma or colectomy
- •Prior exposure to anti-TNF agents, anti-integrins, anti-interleukines 12 and 23 or JAK inhibitor
研究组 & 干预措施
Remsima 100 mg powder for concentrate for solution for infusion
Test
干预措施: Remsima 100 mg powder for concentrate for solution for infusion (Drug)
Entyvio 300 mg powder for concentrate for solution for infusion
Test
干预措施: Entyvio 300 mg powder for concentrate for solution for infusion (Drug)
STEQEYMA 130 mg concentrate for solution for infusion
Test
干预措施: STEQEYMA 130 mg concentrate for solution for infusion (Drug)
Jyseleca 200 mg film-coated tablets
Test
干预措施: Jyseleca 200 mg film-coated tablets (Drug)
结局指标
主要结局
Remission (composite criteria) = no rectal bleeding, normalization of bowel habits (Mayo sub-score of stool frequency = 0) AND faecal calprotectin < 150 µg/g AND no steroids. Remission will be assessed as a binary criterion (yes/no) each month (i.e. 4 weeks-period) between week 4 and week 52, the month being considered as the statistical unit and not the patient.
Remission (composite criteria) = no rectal bleeding, normalization of bowel habits (Mayo sub-score of stool frequency = 0) AND faecal calprotectin < 150 µg/g AND no steroids. Remission will be assessed as a binary criterion (yes/no) each month (i.e. 4 weeks-period) between week 4 and week 52, the month being considered as the statistical unit and not the patient.
次要结局
- 22) Disappearance of rectal bleeding, faecal urgency and normalization of bowel habits at W8, W16, W24, W32, W42, W52, W76 and W104.
- 1) Remission within the first 24 months
- 2) Absence of symptoms within the first 12 or within the first 24 months (= no rectal bleeding, normalization of bowel habits (Mayo sub-score of stool frequency = 0) and no steroids.
- 3) Biological remission (defined using levels of faecal calprotectin < 50 μg/g, < 150 μg/g, < 250 μg/g)
- 4) Endoscopic improvement (mayo endoscopic score (MES) ≤ 1) at W16, W52 and W104
- 5) Endoscopic remission (MES = 0) at W16, W52 and W104
- 6) Histological healing (Nancy index ≤ 1) at W16, W52 and W104
- 7) Clinical remission (total Mayo score ≤ 2 without any subscore >1) at W16, W52 and W104
- 8) Clinical remission (per Modified Mayo Score) is defined as stool frequency subscore (SFS) ≤1, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1at W16, W52 and W104
- 9) Histo-endoscopical mucosal improvement (HEMI) (endoscopic improvement and histologic remission) at W16, W52 and W104
- 10) Histo-endoscopical mucosal healing (HEMH) (endoscopic and histologic remission) at W16, W52 and W104
- 11) Symptomatic remission (no rectal bleeding and normalization of bowel habits (SF Mayo sub-score ≤ 1) at each visit
- 12) Level of faecal calprotectin at each visit
- 13) Rate and number of days spent in clinical remission
- 14) Acceptability of drug regimen (numerical scale from 0 to 10) at W8, W16, W24, W32, W42, W52, W76 and W104
- 15) Time to drug failure
- 16) Time to clinical response including each individual symptoms (rectal bleeding, bowel habits and urgency)
- 17) Partial Mayo score and simple clinical colitis activity index (SCCAI) at W8, W16, W24, W32, W42, W52, W76 and W104
- 18) Rate and type of adverse events at W8, W16, W24, W32, W42, W52, W76 and W104
- 19) Colectomy rate at W8, W16, W24, W32, W42, W52, W76 and W104
- 20) Quality of life assessed by the IBD questionnaire at W8, W16, W24, W32, W42, W52, W76 and W104
- 21) Disability assessed by IBD disability index at W8, W16, W24, W32, W42, W52, W76 and W104
研究者
Lise Laclautre
Scientific
University Hospital Of Clermont-Ferrand
研究点 (34)
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