A Study of Duration of Maintained Efficacy in Rheumatoid Arthritis (RA) Patients Off Treatment With MRA(a Development Code of Tocilizumab, an Anti IL-6 Receptor Monoclonal Antibody.)

Rheumatoid Arthritis Clinical Trial

Official title:

A Study to Investigate the Duration of Maintained Efficacy in Patients With Rheumatoid Arthritis Who Had Treated With MRA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661284
• Other study ID #: MRA226JP
• Status: Completed
• Phase: N/A
• First received: April 15, 2008
• Last updated: July 31, 2012
• Start date: April 2008
• Est. completion date: May 2010

Study information

• Verified date: July 2012
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: May 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies.

Exclusion Criteria:

• Patients who receive DMARDs or immunosuppressants between the last observation in a previous studies and the first observation in this study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Japan	Chugoku region	Chugoku
Japan	Kanto region	Kanto
Japan	Kyushu region	Kyushu
Japan	Sikoku region	Sikoku
Japan	Tohoku region	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies.		every 4th week up to the 48th week	No
Primary	Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy		throughout study	No
Secondary	Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies.		throughout study	No
Secondary	Efficacy: Time course of DAS28 during the treatment-free period in the present study		throughout study	No
Secondary	Efficacy: Relationship between serum IL-6 concentration at the last observation of the previous studies and the time course of DAS28 during the treatment-free period in the present study.		throughout study	No