A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.
研究概览
简要总结
To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed changes in Patient Reported Outcome Measures from baseline.
详细描述
This was a Phase 3, multicenter, open-label, Early Access Study with an induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4 in subjects with moderately to severely active Crohn's Disease (CD) who were eligible to receive biologic therapy or who had failed to respond to, lost response to, or were intolerant to infliximab. Failure of prior therapy was determined by the Investigator. Subjects were to have an 8-week wash-out period prior to Baseline from the last dose of infliximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Males or females 18 years of age and older
- •Females: Not of childbearing potential OR Practicing approved birth control throughout the study and for 150 days after study completion
- •Diagnosis of moderate to severe CD for greater than 16 weeks prior to screening; Crohn's Disease Activity Index score > 220 OR Harvey Bradshaw Index equal to or higher than 7, and who are refractory to optimal conventional therapies such as, 5-aminosalicylic acid (5-ASA), glucocorticoids, and immunosuppressive therapies (azathioprine, 6-MP and MTX)
- •Subjects who failed prior infliximab therapy (as determined by the primary investigator), including those who never clinically responded ("primary non-responders")
排除标准
- •History of cancer other than some skin and cervical cancers
- •History of opportunistic infections, central nervous system (CNS) demyelinating disease, chronic viral hepatitis, or untreated tuberculosis
- •Subjects with other, poorly controlled medical conditions
- •Subjects with any prior exposure to Tysabri® (natalizumab)
- •Subjects who have received any investigational agent in the past 30 days or 5 half-lives prior to screening (whichever is longer)
- •Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
结局指标
主要结局
Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.
时间窗: Up to 24 weeks
Treatment compliance (%) = 100 \* (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).
Mean Extent of Exposure - Duration in Days
时间窗: Up to 24 weeks
Extent of exposure for all adalimumab treated subjects
Total Number of Injections of Adalimumab
时间窗: Up to 24 weeks
Extent of exposure for all adalimumab treated subjects
次要结局
- Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).(Week 12, Week 24, and Last Assessment Value (last nonmissing value))
- 50% Improvement in Draining Fistula Count and Fistula Healing(Week 12, Week 24, Last Assessment Value (last nonmissing value))
- Employment Status: Number of Subjects Employed(Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value))
- Work Productivity and Activity Impairment - Change From Baseline in Absenteeism(Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value))
- Overall Health Care Resource Utilization(Up to 24 weeks)
- Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment(Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value))
- Hematology - Change From Baseline to Final Visit(Up to 24 weeks)
- Clinical Chemistry - Change From Baseline to Final Visit(Up to 24 weeks)
- Urinalysis - Change From Baseline to Final Visit(Up to 24 weeks)
- Work Productivity and Activity Impairment - Change From Baseline in Presenteeism(Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value))
- Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment(Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value))