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.)

Chugai Pharmaceutical189 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

189

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (5)

Chugoku region

Chugoku, Japan

Kanto region

Kanto, Japan

Kyushu region

Kyushu, Japan

Sikoku region

Sikoku, Japan

Tohoku region

Tōhoku, Japan

Outcomes

Primary Outcomes

Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies.

Time frame: every 4th week up to the 48th week

Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy

Time frame: throughout study

Secondary Outcomes

Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies.

Time frame: throughout study

Efficacy: Time course of DAS28 during the treatment-free period in the present study

Time frame: throughout study

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.

Time frame: throughout study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.