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OpenTrials
Completed

NCT Number: NCT00380601

PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA

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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

Primary location

Chugoku region, Chugoku, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987
  • Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
  • Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study

Exclusion criteria

  • Shown to have class-Ⅳ Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug
  • Treated with Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug
  • Subjected to any of the following within 4 weeks before administration of the study drug:
  • Surgical treatment (operations,etc.).
  • Plasma exchange method

Treatment and study plan

MRA(Tocilizumab)

Drug

8mg/kg/4 weeks

Primary outcomes

  1. Frequency of ACR 20％ improvement at the final visit

    Time frame: throughout study

Secondary outcomes

  1. Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set.

    Time frame: throughout study

  2. Time course of DAS28 to the final visit.

    Time frame: throughout study

  3. Time course of steroid sparing effect from first visit to final visit.

    Time frame: throughout study

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Sep 26, 2006
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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