WHO ICTRP trial

A Clinical Trial to study the Safety, Tolerability and Effect of Tocilizumab in…

CTRI/2009/091/000402 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2009/091/000402
Public title A Clinical Trial to study the Safety, Tolerability and Effect of Tocilizumab in Patients with Active Rheumatoid Arthritis taking Background Non-biologic DMARDs and having an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy
Scientific title Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACTSURE
Primary sponsor Roche Products India Pvt Ltd
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 3
Countries Belgium;Denmark;Germany;Ireland;Luxembourg;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;Sweden;Switzerland;Turkey;United Kingdom
Conditions Health Condition 1: null- Active Rheumatoid Arthritis
Interventions Intervention1: Tocilizumab: 8 mg/kg of body weight every 4 weeks for a total of 6 infusions Control Intervention1: NIL: NIL
Registration date Jul 1, 2011
Target size 1500
Secondary IDs MA21573 version 3.0 dated 04 Nov 2008;NCT00750880
Registry page ctri.nic.in

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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