Study of MRA in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144651
• Other study ID #: MRA010JP
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: August 6, 2013
• Start date: August 2001
• Est. completion date: June 2009

Study information

• Verified date: August 2013
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• MRA(Tocilizumab)
8mg/kg/4 weeks for 1 year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR 20% responder rate compared to the pre-treatment in the preceding study		throughout study	No
Primary	Frequency and severity of adverse events and adverse drug reactions		week0,week4,week8,week12,and LOBS	Yes
Secondary	Time course of DAS28,compared to the pre-treatment in the preceding study		week 0,week 4,week 8,week 12, LOBS	No
Secondary	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	No
Secondary	ACR N AUC compared to the pre-treatment in the preceding study		week 0,week 4,week 8,week 12, LOBS	No
Secondary	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	No