A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT01665430
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Tocilizumab will be administered at 8 mg/kg intravenous infusion every 4 weeks, up to 104 weeks.

Study Details

This multicenter, open-label, single arm long-term extension of study WA19926 will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with early, moderate to severe rheumatoid arthritis who have completed the WA19926 core study. Eligible participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

Key Dates

Start date
Jul 31, 2012
Status verified
Feb 2018
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

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

Arms

  • Experimental: Tocilizumab
    Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion every 4 weeks up to 104 weeks.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs), AEs of Special Interest and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 112 weeks ]

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