A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT01649804
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.

Key Dates

Start date
Jul 31, 2012
Status verified
Sep 2016
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: RoActemra/Actemra single arm

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) [ Time Frame: End of Study (Week 104 or early withdrawal) ]

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