An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 463
- 主要终点
- Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs
研究概览
简要总结
This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in participants with ulcerative colitis (UC).
详细描述
This was a single arm, open-label, multicenter study. The primary objectives were to study the effect of adalimumab on QOL (as measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)), the utilization of health care resources, and the costs of care for subjects with UC who were treated with adalimumab in the usual clinical practice setting. The secondary objectives were to further assess the effect of adalimumab on disease activity and to collect additional safety data in subjects with UC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants had to be a male or female between the ages of 18 and 75 years old at the time of the Screening Visit.
- •Participants who had a diagnosis of ulcerative colitis (UC) greater than 90 days prior to baseline (week 0) and failed conventional treatment.
- •Participants diagnosis of active UC was confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy.
- •Participants who had active UC with a Physicians Global Assessment (PGA) score of 2 or 3 and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ≤ 45 at baseline (week 0).
- •Concurrent therapy was required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine (AZA) or 6-mercaptopurine (6-MP)) and, in the judgment of the investigator, had failed to respond to or could not tolerate their treatment. Participants had to be on a concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below):
- •Stable oral corticosteroid dose (prednisone ≥ 20 mg/day or equivalent) for at least 14 days prior to baseline, or
- •Stable oral corticosteroid dose (prednisone < 20 mg/day) for at least 21 days prior to baseline, and/or
- •At least a consecutive 12 weeks (84 days) course of AZA or 6-MP prior to baseline.
排除标准
- •Participants who had a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
- •Participants received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
- •Participants who had previously used infliximab or any anti- tumor necrosis factor (TNF) agent within 56 days of baseline (week 0).
- •Participants who had previously used infliximab or any anti-TNF agent and had not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
- •Participants who had received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of baseline (week 0).
- •Participants who had received intravenous (IV) corticosteroids within 14 days of Screening or during the screening period.
- •Participants who had a current diagnosis of fulminant colitis and/or toxic megacolon.
研究组 & 干预措施
Participants Receiving Adalimumab
Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
干预措施: Adalimumab (Biological)
结局指标
主要结局
Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs
时间窗: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score
时间窗: Week 0 (baseline) and Week 26
The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).
次要结局
- Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)(Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)
- Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)(Week 0 (baseline) and Week 26)
- Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs)(6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months))
- Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures(6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months))
- Percentage of Participants With Absence of Blood in Stool(Week 26)
- Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score(Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)
- Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs(6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months))
- Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization(6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months))
- Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time(Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)
- Mean Change From Baseline in Physician's Global Assessment (PGA)(Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)
- Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment(Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)
- Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed(Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)
- Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage(Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)
- Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working(Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)