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Completed

NCT Number: NCT00661284

A Study of Duration of Maintained Efficacy in Rheumatoid Arthritis (RA) Patients Off Treatment With MRA(a Development Code of Tocilizumab, an Anti IL-6 Receptor Monoclonal Antibody.)

A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment

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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

Observational

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

  • Patients who achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies.

Exclusion criteria

  • Patients who receive DMARDs or immunosuppressants between the last observation in a previous studies and the first observation in this study

Treatment and study plan

Primary outcomes

  1. Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies.

    Time frame: every 4th week up to the 48th week

  2. Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy

    Time frame: throughout study

Secondary outcomes

  1. Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies.

    Time frame: throughout study

  2. Efficacy: Time course of DAS28 during the treatment-free period in the present study

    Time frame: throughout study

  3. Efficacy: Relationship between serum IL-6 concentration at the last observation of the previous studies and the time course of DAS28 during the treatment-free period in the present study.

    Time frame: throughout study

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

A Study to Investigate the Duration of Maintained Efficacy in Patients With Rheumatoid Arthritis Who Had Treated With MRA

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 18, 2008
Registry last updated
Aug 2, 2012

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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