postmarketing surveillance For Investigating success in achieving clinical and functional Remission and Sustaining efficacy with Tocilizumab in BIOlogics naive RA patients

postmarketing surveillance For Investigating success in achieving clinical and functional Remission and Sustaining efficacy with Tocilizumab in BIOlogics naive RA patients - FIRST-BIO study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006914

Enrollment

700

Registered

2011-12-22

Start date

2012-01-01

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

Patients with rheumatoid arthritis who have been diagnosed based on the 2010 ACR/EULAR new classification criteria for RA Patients who have no previous medical history of biological agents for RA Patients whose disease activity is DAS28&gt

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Rheumatoid arthritis diagnosed by ACR/EULAR new classification criteria for RA. Biological drug treatment naive. Moderate to high disease activity (DAS28>=3.2) at baseline.

Exclusion criteria

Exclusion criteria: No criteria

Design outcomes

Primary

Measure	Time frame
Percentage of patients achieving remission by the new ACR/EULAR Boolean based criteria at week 52. (Comparing the remission rate by disease duration)	—

Secondary

Measure	Time frame
Adverse reaction incidence	—

Countries

Japan

Contacts

Public ContactMakoto Nomura

Chugai Pharmaceutical Co. Ltd. Pharmacovigilance Dept.

nomuramkt@chugai-pharm.co.jp03-3273-0905

Outcome results