A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

Sponsor
Hoffmann-La Roche
Study ID
NCT01010503
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, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

Key Dates

Start date
Jun 30, 2009
Status verified
Jul 2014
Primary completion
May 31, 2010
Completion
May 31, 2010

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm

Primary Outcome Measure

Percentage of Participants Adherent to Original Treatment [ Time Frame: Week 24 ]

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