A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT01089023
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab \[RoActemra/Actemra\] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

Key Dates

First listed
Mar 18, 2010
Start date
Jan 31, 2010
Status verified
Jun 2014
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24 ]

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