A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Methotrexate — DRUG
  7.5-20mg po weekly
• tocilizumab [RoActemra/Actemra] — DRUG
  8mg/kg iv every 4 weeks

Study Details

This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Key Dates

Start date

Jul 31, 2005

Status verified

Nov 2016

Primary completion

Dec 31, 2007

Completion

Dec 31, 2007

Study Design

Enrollment

673 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
• Active Comparator: 2

Primary Outcome Measure

Percentage of patients with ACR 20 response [ Time Frame: Week 24 ]

Locations (70)

Find similar trials in Montgomery, AL

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