Study of MRA in Patients With Rheumatoid Arthritis (RA)

An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144651

Enrollment

135

Registered

2005-09-05

Start date

2001-08-31

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 II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.

Interventions

DRUGMRA(Tocilizumab)

8mg/kg/4 weeks for 1 year

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 administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety. * Patients confirmed to have shown the safety in the preceding study.

Exclusion criteria

* Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug * Patients who received any of the following treatments between the start of preceding study and the registration of this study. 1. Plasma exchange therapy 2. Surgical treatment (e.g., operation)

Design outcomes

Primary

Measure	Time frame
ACR 20% responder rate compared to the pre-treatment in the preceding study	throughout study
Frequency and severity of adverse events and adverse drug reactions	week0,week4,week8,week12,and LOBS

Secondary

Measure	Time frame
Time course of DAS28,compared to the pre-treatment in the preceding study	week 0,week 4,week 8,week 12, LOBS
Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study	week 0,week 4,week 8,week 12, LOBS
ACR N AUC compared to the pre-treatment in the preceding study	week 0,week 4,week 8,week 12, LOBS
Time course of the ACR core set variables compared to the pre-treatment in the preceding study	week 0,week 4,week 8,week 12, LOBS

Outcome results

None listed

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