A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  iv every 4 weeks
• tocilizumab [RoActemra/Actemra] — DRUG
  8mg/kg iv every 4 weeks

Study Details

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Key Dates

Start date

Apr 30, 2005

Status verified

Nov 2016

Primary completion

Dec 31, 2007

Completion

Dec 31, 2007

Study Design

Enrollment

1,220 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
• Placebo Comparator: 2

Primary Outcome Measure

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

Locations (76)

Find similar trials in Mesa, AZ

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