A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

Sponsor
Hoffmann-La Roche
Study ID
NCT00996203
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • tocilizumab [RoActemra/Actemra] — DRUG
    8 mg/kg iv every 4 weeks for 24 weeks
  • DMARDs (disease-modifying antirheumatic drugs) — DRUG
    stable doses at investigator's prescription

Study Details

This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

Key Dates

Start date
Oct 31, 2009
Status verified
Feb 2018
Primary completion
Feb 14, 2011
Completion
Feb 14, 2011

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Health Assessment Questionnaire (HAQ) Score [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit ]

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