Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Proportion of subjects who achieved remission
研究概览
简要总结
To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.
详细描述
This is an investigator initiated randomized open label study. This study is designed to compare whether increasing the dose of adalimumab based on the level the drug in the blood to a target level early in the treatment course would lead to better outcomes for patients as compared to the standard doses.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Some of the participants, care providers and investigators will eventually, in the course of the study, have knowledge of the arm they were assigned.
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
- •Age 18 or older.
- •Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation).
- •Active disease based on Harvey Bradshaw Index (HBI >5) and elevated C-reactive protein (CRP) (>normal reference range for local laboratory) OR fecal calprotectin (FCP) (>250 µg/g)
- •Due to commence treatment with ADAL.
排除标准
- •Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease.
- •History of active HIV, hepatitis B or C infection,
- •Patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease.
- •Pregnancy
- •Prior exposure to ADAL
研究组 & 干预措施
Standard clinical care
Adalimumab induction as per standard clinical care:
- Week 0: 160 mg SC
- Week 2: 80 mg SC
- Followed by 40 mg SC every 2 weeks' maintenance therapy
干预措施: Adalimumab (Biological)
Active optimization
Same as Standard clinical care Arm, except:
- If ADAL trough ≤15 μg/ml, dose escalation with 80 mg SC at week 6 followed by 40 mg SC every week
- If ADAL trough >15 μg/ml, no dose escalation and continued standard of care dosing
干预措施: Adalimumab (Biological)
结局指标
主要结局
Proportion of subjects who achieved remission
时间窗: Week 12
Clinical remission will be scored by a Harvey-Bradshaw Index \< 5 AND Biochemical remission will be scored by C-reactive protein \< 5 mg/l OR Fecal calprotectin \<250 μg/g (combination endpoint)
次要结局
- Proportion of steroid free subjects(At Week 12)
- Rates of complications(12 weeks)
- Proportion of subjects who achieved clinical response(From Week 0 to Week 12)
- Subjects well-being(From Week 0 to Week 12)
- Therapeutic drug monitoring(At Week 8, 12)
研究者
waqqas.afif
Dr. Waqqas Afif MD, FRCPC
McGill University Health Centre/Research Institute of the McGill University Health Centre