跳至主要内容
临床试验/CTRI/2011/06/001781
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

发起方
ovartis Healthcare Pvt Ltd

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 infestations
EUCTR2012-003687-52-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 infestations
EUCTR2012-005522-29-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 infestations
EUCTR2012-003687-52-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 infestations
EUCTR2012-003687-52-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 infestations
EUCTR2012-003687-52-ITABBOTT GMBH & Co. KG400