Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

Sponsor
JW Pharmaceutical
Study ID
NCT01211834
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • tocilizumab — DRUG
    intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
  • DMARDs — DRUG
    Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
  • Placebo — DRUG
    intravenously over 1 hour infusion every 4weeks
  • DMARDs — DRUG
    Methotrexate(MTX) and/or 1 DMARDs

Study Details

The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment

Key Dates

Start date
Oct 31, 2009
Status verified
Nov 2010
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab 8mg/kg+DMARDs
  • Placebo Comparator: Placebo+DMARDs

Primary Outcome Measure

Proportion of patients with ACR20 responses [ Time Frame: 24weeks ]

Related Studies