Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

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 MRA012JP

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144547

Enrollment

241

Registered

2005-09-05

Start date

2004-04-30

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 MRA012JP.

Interventions

DRUGMRA(Tocilizumab)

8mg/kg(i.v.)/4weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients must suffer from RA, and must have participated in the preceding study. * Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.

Exclusion criteria

* Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug * Patients who have not been registered by 3 months after week 52 of the preceding study

Design outcomes

Primary

Measure	Time frame
Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)	0W,4W,8W,12W,LOBS
Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria	0W,4W,8W,12W,LOBS

Secondary

Measure	Time frame
Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set	0W,4W,8W,12W,LOBS
Frequency, severity, and seriousness of adverse events and adverse drug reactions	Throughout study

Outcome results

None listed

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