A Study to Evaluate the Pharmacokinetics of Adalimumab in Combination With Methotrexate for the Treatment of Patients With Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 主要终点
- Change in the Modified Baron Score From Baseline to the Final Visit (Week 18) Between the Treatment Groups
研究概览
简要总结
Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active ulcerative colitis.
详细描述
Assess the Pharmacokinetic dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active UC.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
- •Diagnosis of UC confirmed by established criteria, regardless of disease duration.
- •Moderate to severely active UC, defined by a modified Mayo Score ≥6, with confirmed endoscopic activity by central reader (Mayo endoscopic subscore ≥2).
- •Require initiation with adalimumab for induction of remission.
- •Ability of subject to swallow study drug capsules.
- •Ability of subject to participate fully in all aspects of this clinical trial.
- •Written informed consent must be obtained and documented.
排除标准
- •Prior treatment with a TNF antagonist or biological therapy.
- •Prior treatment with MTX.
- •Disease limited to the rectum (proctitis).
- •Documented presence of antibodies against adalimumab.
- •Contraindication for anti-TNF or MTX therapy.
- •Contraindication for endoscopy.
- •Planned surgery.
研究组 & 干预措施
MTX 12.5
Receive once weekly oral dosing with MTX 12.5 mg (n=40) two weeks prior to the initiation of adalimumab 18 weekly doses of MTX and/or placebo in addition to doses of adalimumab
干预措施: MTX 12.5 (Drug)
MTX 12.5
Receive once weekly oral dosing with MTX 12.5 mg (n=40) two weeks prior to the initiation of adalimumab 18 weekly doses of MTX and/or placebo in addition to doses of adalimumab
干预措施: Adalimumab (Drug)
MTX 25 mg
Once weekly oral dosing with MTX 25 mg (n=40) two weeks prior to the initiation of adalimumab 18 weekly doses of MTX in addition to doses of adalimumab
干预措施: MTX 25 (Drug)
MTX 25 mg
Once weekly oral dosing with MTX 25 mg (n=40) two weeks prior to the initiation of adalimumab 18 weekly doses of MTX in addition to doses of adalimumab
干预措施: Adalimumab (Drug)
Placebo
Once weekly oral dosing with placebo (n=20) two weeks prior to the initiation of adalimumab. Subjects will receive 18 weekly doses of placebo in addition to doses of adalimumab
干预措施: Adalimumab (Drug)
结局指标
主要结局
Change in the Modified Baron Score From Baseline to the Final Visit (Week 18) Between the Treatment Groups
时间窗: Baseline up to Week 18
The modified Baron score is scored on a 0-4 scale that evaluates friability, vascular pattern, bleeding and ulceration on a 5-point grading scale with a higher score indicating more severe disease activity. The mean change and 95% CI are based on least square means from the analysis of covariance
次要结局
- Change in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Score From Baseline to the Final Visit (Week 18) Between the Treatment Groups.(Baseline up to Week 18)