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

Sponsor
Hoffmann-La Roche
Study ID
NCT01668966
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.

Study Details

This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.

Key Dates

Start date
Dec 9, 2013
Status verified
Feb 2019
Primary completion
May 11, 2016
Completion
May 11, 2016

Study Design

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

Arms

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

Primary Outcome Measure

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 104 weeks ]

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