Pilot Study to Assess De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Loss of clinical remission
研究概览
简要总结
The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST).
The main question it aims to answer is:
Can we de-escalate UST subcutaneous dose either from every 4 weeks (Q4) to every 8 weeks (Q8) or every 8 weeks (Q8) to every 12 weeks (Q12) in CD or UC patients in deep remission without loosing their response? Researchers will follow UST blood levels, inflammation markers and intestinal mucosa integrity and to see if UST dose can be reduced while maintaining clinical remission.
Participants will:
Change UST dosing from Q4 to Q8 or from Q8 to Q12. Visit the clinic once every 12 weeks for checkups and tests.
详细描述
Participation in this research study will last 12 months and will include 4-6 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical remission
- •Biochemical remission
- •Endoscopy remission
- •Not on corticosteroid
- •A woman must be ;
- •not of childbearing potential
- •of childbearing potential and practicing a medically accepted method of contraception.
- •Able t provide informed consent
排除标准
- •On more than one biologics drug
- •Use of oral or topical steroids within 6months of study entry
- •pregnancy
- •Any issue that could lead to non-compliance, as alcohol, drug use
- •Unable to provide consent or t comply with follw-up visit
研究组 & 干预措施
Ustekinumab Q4w
干预措施: Ustekinumab 90 mg SC q8w (Biological)
Ustekinumab Q8w
干预措施: Ustekinumab 90 mg SC q12w (Biological)
结局指标
主要结局
Loss of clinical remission
时间窗: From treatment switch to end of participation (12 months)
Proportion of patients experiencing loss of remission
次要结局
- Time-to-loss of Remission(From treatment switch to end of participation (12 months))
- Change from Baseline in the C-reactive protein (CRP) level at loss of remission.(12 months)
- Change from Baseline in the calprotectin level at loss of remission.(12 months)
- Disease duration before loss of remission.(Up to 50 years.)
- Change in drug concentration before loss of remission.(12 months)
研究者
waqqas.afif
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre