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Completed

NCT Number: NCT00109408

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients at least 18 years of age with active RA for at least 3 months;
  • patients of reproductive potential must be using reliable methods of contraception.

Exclusion criteria

  • major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
  • treatment with methotrexate (MTX) within 6 months of entering study;
  • patients who have stopped previous MTX treatment due to toxicity or lack of response;
  • women who are pregnant or breast-feeding.

Treatment and study plan

methotrexate

Drug

7.5-20mg po weekly

tocilizumab [RoActemra/Actemra]

Drug

8mg/kg iv every 4 weeks

Primary outcomes

  1. Percentage of patients with ACR 20 response

    Time frame: Week 24

Secondary outcomes

  1. Percentage of patients with ACR 20 response

    Time frame: Week 8

  2. Percentage of patients with ACR 50 and ACR 70 responses

    Time frame: Week 24

  3. Mean change in parameters of ACR core set

    Time frame: Week 24

  4. AEs, laboratory parameters, vital signs.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 28, 2005
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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