A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT00721123
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Tocilizumab (myeloma receptor antibody \[MRA\]) was supplied in sterile solution of 20 mg TCZ/mL for aseptic preparation of infusion bags for IV administration.

Study Details

This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.

Key Dates

Start date
Aug 31, 2005
Status verified
Nov 2013
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

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

Arms

  • Experimental: Tocilizumab 8 mg/kg
    All participants received tocilizumab 8 mg/kg to a maximum of 800 mg, administered by intravenous (IV) infusion over one hour, every 4 weeks. Concomitant therapies were limited to dosage and administration constraints detailed in the protocol.

Primary Outcome Measure

Adverse Event (AE) Summary Over Time [ Time Frame: through 264 Weeks ]

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