A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.
This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab) on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients with active rheumatoid arthritis who have an inadequate response to current biologic or non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or in combination with their current non-biologic DMARD. Anticipated time on study treatment is 52 weeks.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 52 Week, Single Center, Open-label Study to Evaluate Neutrophil Function and Survival Effects of Tocilizumab (TCZ) in Patients With Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy|
- Effects on neutrophil function and survival: Neutrophil morphology by light microscopy, function by ex vivo surface molecule expression using flow cytometry, survival by ex vivo evaluation of apoptosis utilizing a combination of techniques [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Safety and benefit-risk assessments, according to Summary of Product Characteristics (SPC) and improvements in disease activity score (DAS28) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: Single Arm||
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 52 weeks