临床试验/NCT00417391

NCT00417391已完成2 期

Phase II Study of RR110 in Patients With Active Crohn's Disease

R&R Inc.0 个研究点目标入组 24 人开始时间: 2006年12月最近更新: 2008年5月29日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: R&R Inc.
入组人数: 24
主要终点: Change in Crohn's disease active index (CDAI) score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with CDAI score ranging from 220 to 450
•Patients with CRP > 1 mg/dL
•Patients who can be hospitalized at least 2 weeks after first administration

排除标准

•Patients who have previously used anti-TNF antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening
•Patients who have had surgical bowel resections within 4 weeks of screening
•Patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening

研究组 & 干预措施

1 mg RR110

Experimental

1 mg RR110

干预措施: RR110 (Tamibarotene) (Drug)

4 mg RR110

Experimental

4 mg RR110

干预措施: RR110 (Tamibarotene) (Drug)

结局指标

主要结局

Change in Crohn's disease active index (CDAI) score

时间窗: 8 weeks

次要结局

Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline(8 weeks)
Rate of clinical remission as defined by CDAI < 150(8 weeks)
Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores(10 weeks)
Safety parameters(10 weeks)

研究者

发起方

R&R Inc.

申办方类型

Industry

相似试验

已完成

2 期

Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia GravisGeneralized Myasthenia Gravis

NCT03315130Ra Pharmaceuticals45

已完成

2 期

CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal CancerFallopian Tube CancerPrimary Peritoneal CancerOvarian Cancer

NCT01652079Massachusetts General Hospital63

已完成

1 期

A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV MelanomaUnresectable Stage III or Stage IV Melanoma

NCT00412828CuraGen Corporation117

撤回

2 期

Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal CancerCCR5Microsatellite StableMetastaticColorectal Cancer

NCT05730673CytoDyn, Inc.

已完成

2 期

A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab in Patients With GlioblastomaGlioblastoma MultiformeGlioblastoma

NCT01564914Tracon Pharmaceuticals Inc.22