Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

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 MRA213JP

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144534

Enrollment

115

Registered

2005-09-05

Start date

2004-06-30

Completion date

2009-06-30

Last updated

2009-12-23

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 MRA213JP.

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

* Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety. * In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion criteria

* Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug * Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug * Have not been registered by 3 months after the full code-breaking of the preceding study * Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study * Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Design outcomes

Primary

Measure	Time frame
Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria	throughout study
Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions	throughout study
Pharmacokinetics of the serum MRA concentration	0W,4W,8W,12W,LOBS

Secondary

Measure	Time frame
Efficacy: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

Outcome results

None listed

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