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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Phase II

Further Study Details: 

Primary Outcomes: Efficacy:; ACR 20% responder rate compared to the pre-treatment in the preceding study; Safety:; Frequency and severity of adverse events and adverse drug reactions at 0W,4W,8W,12W,LOBS
Secondary Outcomes: Efficacy:; Time course of DAS28, Time course of the ACR 20%, 50%, and 70% responder rates and time course of the ACR core set variables, ACR N AUC compared to the pre-treatment in the preceding study at 0W,4W,8W,12W,LOBS
Expected Total Enrollment:  135

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

Criteria

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)

Study chairs or principal investigators

Takahiro Kakehi,  Study Director,  Chugai Pharmaceutical Co., Ltd.   

Study ID Numbers:  MRA010JP
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144651
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13