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Completed

NCT Number: NCT00144651

Study of MRA in Patients With Rheumatoid Arthritis (RA)

This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.

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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 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
  • Patients confirmed to have shown the safety in the preceding study.

Exclusion criteria

  • Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
  • Patients who received any of the following treatments between the start of preceding study and the registration of this study.
  • Plasma exchange therapy
  • Surgical treatment (e.g., operation)

Treatment and study plan

MRA(Tocilizumab)

Drug

8mg/kg/4 weeks for 1 year

Primary outcomes

  1. ACR 20% responder rate compared to the pre-treatment in the preceding study

    Time frame: throughout study

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

    Time frame: week0,week4,week8,week12,and LOBS

Secondary outcomes

  1. Time course of DAS28,compared to the pre-treatment in the preceding study

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

  2. Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study

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

  3. ACR N AUC compared to the pre-treatment in the preceding study

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

  4. Time course of the ACR core set variables compared to the pre-treatment in the preceding study

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

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP

Important dates

Study start
2001
Primary completion
2009
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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