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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144586

Enrollment

Registered

2005-09-05

Start date

2005-03-31

Completion date

2009-06-30

Last updated

2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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.

Interventions

DRUGMRA(Tocilizumab)

8mg/kg/4 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.	Week 0, then every 4 Week

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026