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Completed

NCT Number: NCT00144534

Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.

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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

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
  • In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion criteria

  • Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
  • Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
  • Have not been registered by 3 months after the full code-breaking of the preceding study
  • Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
  • Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Treatment and study plan

MRA (Tocilizumab)

Drug

8mg/kg/4 weeks

Primary outcomes

  1. Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria

    Time frame: throughout study

  2. Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions

    Time frame: throughout study

  3. Pharmacokinetics of the serum MRA concentration

    Time frame: 0W,4W,8W,12W,LOBS

Secondary outcomes

  1. Efficacy:time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set

    Time frame: 0W,4W,8W,12W,LOBS

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP

Important dates

Study start
2004
Primary completion
2005
Study completion
2009
First posted
Sep 5, 2005
Registry last updated
Dec 23, 2009

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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