To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Sponsor
JW Pharmaceutical
Study ID
NCT01256736
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
    DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Study Details

The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.

Key Dates

Start date
Mar 31, 2010
Status verified
Nov 2013
Primary completion
Dec 31, 2011
Completion
Nov 30, 2013

Study Design

Enrollment
89 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab 8mg/kg + DMARDs

Primary Outcome Measure

Safety results [ Time Frame: 48weeks ]

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