A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 592
- 主要终点
- Mayo Score: Change From Baseline Over Time
研究概览
简要总结
To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subject must have successfully enrolled and completed either study M06-826 (NCT00385736) or study M06-827 (NCT00408629)
- •Subject is judged to be in generally good health as determined by the principal investigator
排除标准
- •Subject has not responded to weekly adalimumab therapy in M06-826 (NCT00385736) or M06-827 (NCT00408629)
- •Subject considered by the investigator, for any reason, to be an unsuitable candidate
- •Female subject who is pregnant or breast-feeding or considering becoming pregnant
研究组 & 干预措施
Adalimumab 40 mg EOW/EW
Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
干预措施: adalimumab (Biological)
结局指标
主要结局
Mayo Score: Change From Baseline Over Time
时间窗: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Partial Mayo Score: Change From Baseline Over Time
时间窗: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.
次要结局
- WPAI:GH Overall Work Impairment: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- Hematology: Mean Change From Baseline to Final Values in Hematocrit(Baseline (Week 0), final value (up to 5 years))
- Percentage of Participants With Remission Per Partial Mayo Score Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- WPAI:GH Activity Impairment: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- Colectomy Rate(5 years)
- Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid(Baseline (Week 0), final value (up to 5 years))
- Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein(Baseline (Week 0), final value (up to 5 years))
- Mayo Endoscopy Subscore: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- Mayo Stool Frequency Subscore: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations(5 years)
- Hematology: Mean Change From Baseline to Final Values in Hemoglobin(Baseline (Week 0), final value (up to 5 years))
- Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase(Baseline (Week 0), final value (up to 5 years))
- Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides(Baseline (Week 0), final value (up to 5 years))
- Mayo Rectal Bleeding Subscore: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils(Baseline (Week 0), final value (up to 5 years))
- Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein(Baseline (Week 0), final value (up to 5 years))
- WPAI:GH Impairment While Working: Change From Baseline Over Time(Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388)
- Number of Participants With Adverse Events(From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks))