EUCTR2013-004435-72-DE进行中（未招募）1 期
AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Part 1 (Open-label Extension)
- •- Patients previously enrolled in Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol
- •Part 2 (Safety Monitoring)
- •- Patients who participated in one of the etrolizumab Phase II OLE study or Phase III studies and are not eligible or chose not to enter Part 1 (OLE)
- •- Patients who transfer from Part 1 (OLE)
- •- Completion of the 12-week safety follow-up prior to entering.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1907
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 193
排除标准
- •Part 1 (Open-label Extension)
- •- Any new, significant, uncontrolled condition
- •- Receipt of the following since commencement of the Phase II OLE or
- •Phase III controlled studies: Use of anti-adhesion molecules
- •Part 2 (Safety Monitoring)
- •- No exclusion criteria
研究者
相似试验
进行中（未招募）
1 期
An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studieslcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2013-004435-72-BGF. Hoffmann-La Roche Ltd2,100
进行中（未招募）
1 期
An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studieslcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2013-004435-72-PTF. Hoffmann-La Roche Ltd2,100
进行中（未招募）
1 期
An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studieslcerative colitisMedDRA version: 17.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2013-004435-72-GRF. Hoffmann-La Roche Ltd2,568
进行中（未招募）
1 期
An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase III studiesEUCTR2013-004435-72-FRF. Hoffmann-La Roche Ltd2,568
招募中
3 期
AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIESinflammatory bowel disease10017969Ulcerative colitisNL-OMON53027Hoffmann-La Roche33