A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab — DRUG
  Tocilizumab was supplied in vials.
• Placebo to tocilizumab — DRUG
  Placebo to tocilizumab was supplied in vials.
• Methotrexate — DRUG
  Initially, patients received methotrexate 7.5 mg (3, 2.5 mg tablets) orally once a week. If a patient had swollen or tender joints, the dose was increased to 15 mg and 20 mg weekly, at the Week 4 and Week 8 visits, respectively.
• Placebo to methotrexate — DRUG
  Patients received placebo to methotrexate orally once a week.

Study Details

This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

Key Dates

Start date

Oct 31, 2009

Status verified

Jun 2017

Primary completion

May 31, 2012

Completion

Jan 28, 2014

Study Design

Enrollment

1,162 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: (A) Tocilizumab 8 mg/kg + placebo to methotrexate
  Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
• Experimental: (B) Tocilizumab 8 mg/kg + methotrexate
  Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
• Experimental: (C) Tocilizumab 4 mg/kg + methotrexate
  Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
• Active Comparator: (D) Placebo to tocilizumab + methotrexate
  Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.

Primary Outcome Measure

Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24 [ Time Frame: Week 24 ]

Locations (61)

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