CTRI/2011/06/001781已完成2 期
A Randomized, Double-blind, Controlled Study to Evaluate Pharmokinetic, Pharmacodynamic, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and One or Two Anti-TNF Therapies.
ovartis Healthcare Pvt Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Rheumatoid arthritis as defined by the 1987 ACR classification
- •2. Severe active seropositive disease
- •3. Inadequate response or intolerance to other DMARDs and anti-TNFs
- •4. Treatment with Methotrexate
排除标准
- •1.Patients with systemic manifestations of rheumatoid arthritis
- •2.Female patients nursing
- •3.Women of childbearing potential unless using birth control
- •4. Active infection
- •5. Known immunodeficiency syndrome
- •6.Positive Hepatitis B surface antigen or antibodies to Hepatitis C
- •7.History of cancer
- •8.Other protocol-defined inclusion/exclusion criteria may apply
研究者
相似试验
进行中(未招募)
不适用
A double-blind, placebo-controlled study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 with or without ribavirin in people with hepatitis C virus (HCV) that have not been treated before. Experimental means that they have not been approved by any regulatory agency for sale to the public.Chronic Hepatitis C InfectionMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-003687-52-PTAbbott GmbH & Co. KG400
进行中(未招募)
不适用
A double-blind, placebo-contolled study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 with or without a drug called ribavirin in people with hepatitis C virus (HCV) that have not been treated before. Experimental means that they have not been approved by any regulatory agency for sale to the public.Chronic Hepatitis C InfectionMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-005522-29-GBAbbVie Deutschland GmbH & Co. KG314
进行中(未招募)
不适用
A double-blind, placebo-controlled study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 with or without ribavirin in people with hepatitis C virus (HCV) that have not been treated before. Experimental means that they have not been approved by any regulatory agency for sale to the public.Chronic Hepatitis C InfectionMedDRA version: 15.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-003687-52-ESAbbott GmbH & Co. KG400
进行中(未招募)
不适用
A double-blind, placebo-controlled study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 with or without ribavirin in people with hepatitis C virus (HCV) that have not been treated before. Experimental means that they have not been approved by any regulatory agency for sale to the public.Chronic Hepatitis C InfectionMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-003687-52-HUAbbott GmbH & Co. KG400
进行中(未招募)
不适用
A double-blind, placebo-controlled study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 with or without ribavirin in people with hepatitis C virus (HCV) that have not been treated before. ''Experimental'' means that they have not been approved by any regulatory agency for sale to the public.Chronic Hepatitis C Infection.MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-003687-52-ITABBOTT GMBH & Co. KG400
