Study of MRA in Patients With Rheumatoid Arthritis (RA)

Chugai Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: MRA(Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144651

MRA010JP

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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135 participants in 1 patient group

1

Experimental group

Treatment:

Drug: MRA(Tocilizumab)