Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

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 MRA012JP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144547
• Other study ID #: MRA214JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: August 6, 2013
• Start date: April 2004
• 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 MRA012JP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: June 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion criteria

• Patients must suffer from RA, and must have participated in the preceding study.

• Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.

Exclusion criteria

• Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug

• Patients who have not been registered by 3 months after week 52 of the preceding 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(i.v.)/4weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)		0W,4W,8W,12W,LOBS	No
Primary	Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria		0W,4W,8W,12W,LOBS	No
Secondary	Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set		0W,4W,8W,12W,LOBS	No
Secondary	Frequency, severity, and seriousness of adverse events and adverse drug reactions		Throughout study	Yes