Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

Conditions

• Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex

ALL

Age

20 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab + methotrexate(MTX) — DRUG
  Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week
• Tocilizumab placebo + methotrexate(MTX) — DRUG
  Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week

Study Details

This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.

Key Dates

Start date

Dec 31, 2010

Status verified

Dec 2012

Primary completion

Oct 31, 2012

Completion

Oct 31, 2012

Study Design

Enrollment

86 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
• Placebo Comparator: 2

Primary Outcome Measure

Proportion of patients with an American College of Rheumatology 20(ACR20) response [ Time Frame: at baseline and week 24 ]

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