Elucidation of the pharmacokinetics of methotrexate and establishment of the optimum medication method in Japanese rheumatoid arthritis patients.

Elucidation of the pharmacokinetics of methotrexate and establishment of the optimum medication method in Japanese rheumatoid arthritis patients. - Methotrexate as an anchor drug in Japanese rheumatoid arthritis monitored by erythrocyte polyglutamate concentration in Keio Rheumatology Expert Meeting.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000008514

Enrollment

100

Registered

2012-07-24

Start date

2012-07-30

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with rheumatoid arthritis diagnosed with ACR/EULAR classification criteria 2)Patients without use of previous MTX or biologic agents 3)Patients who will receive MTX treatment 4)Patients who can be treated with biologic agent treatment if efficacy of MTX is insufficient

Exclusion criteria

Exclusion criteria: 1)Patients who cannot be treated with MTX 2)Patients who cannot be treated with biologic agents 3)Patients who are pregnant, who are nursing or who hope to be pregnant

Design outcomes

Primary

Measure	Time frame
Low disease activity(SDAI<11 ) rate at week 12	—

Secondary

Measure	Time frame
1. Concentration of MTX-PG at week 4, 8, 12, 24 and 36 2. Remission rate (SDAI<3.3) at week 12,24 and 36 3. Radiological remission rate 4. Adverse effect rate	—

Countries

Japan

Contacts

Public ContactChihiro Takahashi

Department of Internal Medicine, Keio University School of Medicine Division of Rheumatology, Department of Internal Medicine

chihiro.takahashi@z6.keio.jp

Outcome results