An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT01951170
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    162 milligrams (mg) tocilizumab was administered subcutaneously once weekly for 24 weeks

Study Details

This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in patients with active moderate to severe rheumatoid arthritis. Participants will receive a subcutaneous dose of tocilizumab 162 mg once weekly. The anticipated time on study treatment is 24 weeks.

Key Dates

Start date
Nov 30, 2013
Status verified
Aug 2016
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

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

Arms

  • Experimental: Tocilizumab
    Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.

Primary Outcome Measure

Change From Baseline in Genant-modified Total Sharp Score (mTSS) [ Time Frame: From baseline to Week 24 ]

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