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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144586
• Other study ID #: MRA222JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: August 6, 2013
• Start date: March 2005
• 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 III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.		throughout study	No
Secondary	Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.		Week 0, then every 4 Week	No