Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis

Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis - Comparison of tocilizumab and high-dose methotrexate on rheumatoid arthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007380

Enrollment

Registered

2012-05-01

Start date

2012-04-01

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

rheumatoid arthritis

Interventions

tocilizumab + methotrexate (10mg/week) high-dose methotrexate (stepwisely increased to 16mg/week)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who fulfilled 1987 ACR and 2010 ACR/EULAR critereia of RA Patients not treated with Biologics Patients treated with MTX of 10 mg/week more than 4weeks Active RA patients of DAS28 >/= 3.2

Exclusion criteria

Exclusion criteria: TCZ intolerable patients Pregnant or possibly pregnant patients Serum ALT >/= 3x normal value

Design outcomes

Primary

Measure	Time frame
To determine which is acceptable; to increase the dose of MTX upto 16 mg/W or to add tocilizumab on 10 mg of MTX through assessment of the clinical outcome by DAS28 and frequency of adverse reaction in the clinical course.	—

Countries

Japan

Contacts

Public ContactYuji Nozaki

Kinki University Faclty of Medicine Division of Hematology and Rheumatology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026