The efficacy and safety of tocilizumab (trade name: Actemra) in RA patients.

The efficacy and safety of tocilizumab (trade name: Actemra) in RA patients. - The efficacy and safety of tocilizumab (trade name: Actemra) in RA patients.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000002843

Enrollment

Registered

2010-01-01

Start date

2009-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhumatoid arthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients at least 20 years old at enrolment 2) Patients diagnosed with RA based on the 1987 classification criteria of the American College of Rheumatology (ACR) 3) Patients who have had an inadequate response to at least one DMARD (including MTX) 4) Patients who have expressed their informed consent in writing

Exclusion criteria

Exclusion criteria: 1) Patients with a history of sensitivity to any of the ingredients of Actemra 2) Patients with a serious concomitant infection 3) Patients with active tuberculosis 4) Patients with a lymphocyte count less than 500/ mcL 5) Patients with HCV, HBV or HIV infections 6) Other patients whom the investigator considers to be unsuitable for the study

Design outcomes

Primary

Measure	Time frame
An appropriate IL-6 cut-off value will be determined by comparing the difference of serum IL-6 concentrations between patients that developed infection and patients that did not develop infection.	—

Countries

Japan

Outcome results