NL-OMON47815已完成4 期
A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST) - Vedolizumab IV in the treatment of chronic pouchitis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male or female subjects 18 to 80 years, inclusive.
- •- History of IPAA for UC completed at least 1 year prior to the Day 1
- •(Randomization) Visit.
- •Pouchitis that is chronic or recurrent, defined by an mPDAI score >=5 assessed
- •as the average from 3 days immediately prior to the Baseline endoscopy and a
- •minimum endoscopic subscore of 2 (outside the staple or suture line) with
- •either (a) >=3 recurrent episodes within 1 year prior to the Screening Period
- •treated with >=2 weeks of antibiotic or other prescription therapy, or (b)
- •requiring maintenance antibiotic therapy taken continuously for >=4 weeks
- •immediately prior to the Baseline Endoscopy Visit.
排除标准
- •- Crohn*s disease (CD), CD of the pouch, irritable pouch syndrome (IPS),
- •isolated or predominant cuffitis, diverting stoma, or mechanical complications
- •of the pouch.
- •- Previous treatment with vedolizumab, natalizumab, efalizumab, rituximab,
- •etrolizumab, or anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1)
- •- Any investigational or approved biologic or biosimilar agent within 60 days
- •of randomization.
- •- Nonbiologic investigational therapy within 30 days prior to randomization.
- •- Active or latent tuberculosis.
- •- Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)
- •infection or a known history of human immunodeficiency virus (HIV) infection
- •(or is found to be seropositive at Screening) or subject is immunodeficient.
- •- Active, severe infection.
- •- Positive progressive multifocal leukoencephalopathy (PML) subjective symptom
- •checklist at Screening.
研究者
相似试验
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome. - NDEUCTR2005-005372-32-ITGLAXO SMITHKLINE400
进行中（未招募）
1 期
A randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of two doses of ketoprofen (as lysinate) lozenges (6.25mg and 12.5mg ) in patients with sore throat” - KRYSTAupper respiratory illness : sore throatMedDRA version: 9.1Level: LLTClassification code 10041367Term: Sore throatEUCTR2008-008265-36-FRSANOFI-AVENTIS GROUPE835
进行中（未招募）
1 期
The effect of Tiotropium+olodaterol fixed dose combination on exercise endurance time during constant work load cycle test in patients with COPDChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-004253-11-GBBoehringer Ingelheim Limited544
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of two doses of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) in patients with sore throat” - KRYSTAEUCTR2008-008265-36-FISANOFI-AVENTIS GROUPE835
进行中（未招募）
不适用
Efficacy and safety of 2 doses of Tiotropium Respimat compared to placebo in adolescents with severe persistent asthmapatients of either sex, 12 to 17 years old, with a diagnosis of severe persistent asthmaMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-021778-13-DEBoehringer Ingelheim Pharma GmbH & Co. KG375