A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis.

Sponsor
Hoffmann-La Roche
Study ID
NCT01988012
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • tocilizumab — BIOLOGICAL
    162 milligram (mg) administered subcutaneously once weekly for 24 weeks

Study Details

A multi-center, open-label single-arm study to evaluate the efficacy and safety of tocilizumab administered as a single, weekly injection in adults with rheumatoid arthritis. Combination therapy with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) was permitted.

Key Dates

Start date
Jan 31, 2014
Status verified
Jan 2017
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: Tocilizumab
    Adults with rheumatoid arthritis will be treated with tocilizumab for 24 weeks followed by an 8 week follow-up period without treatment.

Primary Outcome Measure

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission and CDAI Low Disease Activity [ Time Frame: Week 24 ]

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