A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT00951275
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key Dates

First listed
Aug 4, 2009
Start date
Oct 31, 2009
Status verified
Jun 2017
Primary completion
Jul 22, 2011
Completion
Jul 22, 2011

Study Design

Enrollment
105 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin [ Time Frame: Week 4 ]

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