EUCTR2014-003509-13-IT进行中（未招募）1 期
An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects WithModerately to Severely Active Crohn's Disease Treated With VedolizumabIV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 101
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
- •- The subject has a diagnosis of moderately to severely active CD at least 3 months prior to enrollment, with a CDAI score of 220-450 during the
- •Screening Period, a SES-CD score of =7 and presence of at least one mucosal ulceration documented by recorded ileocolonoscopy at Screening assessed by the central reader.
- •- The subject has CD with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
- •- The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
- •¿ Immunomodulators:
- •i. The subject has signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (=
- •1.5 mg/kg) or 6-mercaptopurine (=0.75 mg/kg), OR
- •ii. The subject has a history of intolerance (including but not limited to nausea/ vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine S-methyltransferase non wild
- •type [where wild type is defined as TPMT*1/*1], infection) to at least 1 immunomodulator.
- •¿ TNF-¿ antagonists:
- •i. The subject has signs and symptoms of persistently active disease despite a history of at least 1 induction with:
- •a) Infliximab: 4-week regimen of 5 mg/kg, 2 doses at 2 weeks apart, OR
- •b) Adalimumab: 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15, OR
- •c) Certolizumab: 4-week regimen of 400 mg initially at Weeks 0, 2, 4 OR
- •ii. The subject has recurrence of symptoms during maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not
- •qualify), OR
- •iii. The subject has a history of intolerance of infliximab, adalimumab, or certolizumab, including but not limited to, infusion-related reaction, demyelination, congestive heart failure, or infection.
- •¿ Corticosteroids
- •i. Signs and symptoms of persistently active disease despite a history of at least one
- •4-week induction regimen that included a dose equivalent to prednisone 30 mg
- •daily orally for 2 weeks or IV for 1 week, OR
- •ii. Signs and symptoms of persistently active disease despite treatment with budesonide 9 mg daily or 6 mg daily for maintenance, OR
- •iii. At least one failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally, OR
- •iv. History of intolerance to corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- The subject has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
- •a) History of TB.
- •b) A diagnostic TB test performed during screening that is positive, as defined by:
- •i. A positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests OR
- •ii. A tuberculin skin test reaction =10 mm (=5 mm in patients receiving the equivalent of >15 mg/day prednisone)
- •- The subject has chronic hepatitis B (HBV) or hepatitis C (HCV) infection.
- •- The subject has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- •- The subject has evidence of active C. difficile infection or is having treatment for C. difficile infection or other intestinal pathogens during
- •- The subject has evidence of an active infection during Screening.
- •- The subject has received any investigational compound within 60 days of enrollment.
- •- The subject has received any biologics within 60 days of enrollment.
- •- The subject has received any live vaccinations within 30 days prior to enrollment.
- •- The subject has a positive PML subjective symptom checklist during screening and prior to the administration of study drug on Day 1.
研究者
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