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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Methotrexate — DRUG
  10-25mg weekly
• Placebo — DRUG
  iv every 4 weeks
• tocilizumab [RoActemra/Actemra] — DRUG
  8mg/kg iv every 4 weeks
• tocilizumab [RoActemra/Actemra] — DRUG
  4mg/kg iv every 4 weeks

Study Details

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Key Dates

Start date

May 31, 2005

Status verified

Nov 2016

Primary completion

Nov 30, 2007

Completion

Nov 30, 2007

Study Design

Enrollment

499 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
• Experimental: 2
• Placebo Comparator: 3

Primary Outcome Measure

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

Locations (97)

Find similar trials in Birmingham, AL

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