Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP

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 MRA220JP or MRA221JP.

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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

RA patients who participated in the previous studies
Patients who completed the last observation in the previous studies
Patients who were confirmed to have no problems with safety in the previous studies.

Exclusion criteria

Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product
Patients who were not enrolled by 3 months after the last observation day of the previous study

Treatment and study plan

MRA(Tocilizumab)

Drug

8mg/kg/4 weeks

Primary outcomes

20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.

Time frame: throughout study

Secondary outcomes

Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.

Time frame: Week 0, then every 4 Week

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 MRA220JP or MRA221JP

Important dates

Study start: 2005
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.

Published trials that share one or more normalized conditions with this study.

Completed