Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

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 MRA213JP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144534
• Other study ID #: MRA215JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: December 21, 2009
• Start date: June 2004
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• 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 MRA213JP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: June 2009
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion criteria

• Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.

• In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion criteria

• Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug

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

• Have not been registered by 3 months after the full code-breaking of the preceding study

• Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study

• Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

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	Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria		throughout study	No
Primary	Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions		throughout study	No
Primary	Pharmacokinetics of the serum MRA concentration		0W,4W,8W,12W,LOBS	No
Secondary	Efficacy: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