2024-514326-23-00招募中4 期
An Open-Label Extension and long-term efficacy and safety monitoring study of patients with Crohn's disease previously included in the loss of RESponse to Ustekinumab treated by dose Escalation study (REScUE-OLE)
Belgian IBD Research and Development, Belgian IBD Research and Development15 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 15
- 主要终点
- Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at both week 56 and week 112 of the study (sustained steroid-free clinical remission).
研究概览
简要总结
To assess the long-term clinical efficacy of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Previous inclusion in the REScUE study and having reached the end of this study at week
- •Adequate contraception in females of reproductive age (oral, transdermal, injectable contraception, intra-uterine device, sterilisation or barrier method). Adequate contraception in males (sterilization or barrier method) if his female partner is of reproductive age.
- •Have the capacity to understand and sign an informed consent form.
- •Be able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Patients previously enrolled to the ustekinumab 90 mg SC Q4w-arm during REScUE who were on concomitant steroid use >20 mg prednisone equivalents (budesonide >6 mg; beclomethasone dipropionaat >5 mg) at any time point in the last 28 days before the end of REScUE at week
- •Patients previously enrolled to the ustekinumab 90 mg SC Q4w-arm during REScUE that did not reach the following criteria at the end of REScUE at week 48: Clinical remission (defined as average AP≤1 and average SF≤3) OR clinical response (defined as a drop of at least 50% in average AP and/or a drop of at least 50% in average SF as compared to REScUE baseline, and both average AP and SF no worse than REScUE baseline) AND Endoscopic remission (defined as a total SES-CD <5 or for isolated ileitis SES-CD <4) OR endoscopic response (defined as a drop of at least 50% in total SES-CD score as compared to REScUE baseline)
- •Patients who developed an anaphylactic or severe allergic reaction to study medication during REScUE.
- •Patients with any of the following laboratory tests at W0 of REScUE-OLE : Hemoglobin level <8.5 g/dL, Platelets level <100.000 /mm3, Serum creatinine level ≥1.7 mg/dL, AST and ALT level >3 times the upper limit of normal range, Direct (conjugated) bilirubin level ≥3.0 mg/dL
- •Patients with an ongoing treatment with another concomitant biological (vedolizumab, anti-TNF), a JAK-inhibitor or any investigational product for the treatment of CD at the end of REScUE at week
- •Patients who experience or have an ongoing infection event confirmed by positive stool or blood testing (including gastrointestinal pathogens, tuberculosis, HIV, hepatitis B, hepatitis C) should not initiate REScUE-OLE until (i) this event has completely resolved as shown by the termination of treatment with anti-infective medication, or (ii) this event is considered to be in stable remission under anti-infective medication in case of HIV, hepatitis B and hepatitis C.
- •Patients with an impassable stenosis even after attempt of endoscopic balloon dilatation.
- •Patients with an intra-abdominal abscess, or patients with an intra-anal abscess without adequate drainage by e.g. a seton placement.
结局指标
主要结局
Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at both week 56 and week 112 of the study (sustained steroid-free clinical remission).
Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at both week 56 and week 112 of the study (sustained steroid-free clinical remission).
次要结局
- Incidence and severity of adverse events in both treatment arms.
- Time to CD worsening (as defined in section 3.2.1 of the protocol) in both treatment arms.
- Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at week 56 of the study.
- Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤week 100), and that reached steroid-free clinical remission (PRO-2 remission: average AP≤1 and average SF≤3 without any steroid use in the previous 28 days) at week 112.
- Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP≤1 and average SF≤3) at both week 56 and week 112 of the study (sustained clinical remission).
- Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP≤1 and average SF≤3) at week 56 of the study.
- Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP≤1 and average SF≤3) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤week 100), and that reached clinical remission (PRO-2 remission: average AP≤1 and average SF≤3) at week 112.
- Proportion of patients in both treatment arms with biomarker remission (CRP <5 mg/L and FC≤250 µg/g) at week 56 of the study.
- Proportion of patients in both treatment arms with biomarker remission (CRP <5 mg/L and FC≤250 µg/g) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤week 100), and that reached biomarker remission (CRP<5 mg/L and FC≤250 µg/g) at week 112.
- Proportion of patients in both treatment arms in endoscopic remission (total SES-CD <5 or for isolated ileitis <4) at week 56 of the study.
- Proportion of patients in both treatment arms in endoscopic remission (total SES-CD <5 or for isolated ileitis <4) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤ week 100), and that reached endoscopic remission (total SES-CD <5 or for isolated ileitis <4) at week 112.
- Proportion of patients in both treatment arms in complete endoscopic remission (total SES-CD <3) at week 56 of the study.
- Proportion of patients in both treatment arms in complete endoscopic remission (total SES-CD <3) at week 112 of the study.
- Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (≤ week 100), and that reached complete endoscopic remission (total SES-CD<3) at week 112.
研究者
Lieven Pouillon
Scientific
Belgian IBD Research and Development
研究点 (15)
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