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Completed

NCT Number: NCT00144547

Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

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 MRA012JP.

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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 and older

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

  • Patients must suffer from RA, and must have participated in the preceding study.
  • Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.

Exclusion criteria

  • Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
  • Patients who have not been registered by 3 months after week 52 of the preceding study

Treatment and study plan

MRA(Tocilizumab)

Drug

8mg/kg(i.v.)/4weeks

Primary outcomes

  1. Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)

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

  2. Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria

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

Secondary outcomes

  1. 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

  2. Frequency, severity, and seriousness of adverse events and adverse drug reactions

    Time frame: Throughout study

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 MRA012JP

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Sep 5, 2005
Registry last updated
Aug 9, 2013

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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