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

Chugai Pharmaceutical42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

MRA(Tocilizumab)DRUG

8mg/kg/4 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

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

Data from ClinicalTrials.gov

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