A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926

Sponsor
Hoffmann-La Roche
Study ID
NCT01730456
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

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

Key Dates

Start date
Oct 31, 2012
Status verified
Nov 2016
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

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

Arms

  • Experimental: RoActemra/Actemra

Primary Outcome Measure

Long-term safety: Incidence of adverse events [ Time Frame: approximately 3 years ]

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