Prediction of the therapeutic response and adverse events to methotrexate by monitoring methotrexate-polyglutamates (MTX-PGs) concentration in erythrocytes in Japanese patients with rheumatoid arthritis (RA).

Prediction of the therapeutic response and adverse events to methotrexate by monitoring methotrexate-polyglutamates (MTX-PGs) concentration in erythrocytes in Japanese patients with rheumatoid arthritis (RA). - Study in Japanese patients with RA for prediction of the therapeutic response and adverse events to methotrexate by monitoring MTX-PG concentrations in erythrocytes.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000020134

Enrollment

100

Registered

2015-12-09

Start date

2013-07-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who met the 2010 American College of Rheumatology (ACR) /European League Against Rheumatism (EULAR) criteria for RA. 2. MTX-naive patients who are going to start oral MTX treatment and patients who have already been treated with a stable dose of MTX.

Exclusion criteria

Exclusion criteria: 1. Patients who have already been treated with Leflunomide and biologics. 2. Patients who can not be treated with MTX. 3. Patients who are pregnant, breast-feed, and desire to be pregnant.

Design outcomes

Primary

Measure	Time frame
DAS28CRP improvement from baseline (delta DAS28CRP) > 1.2 at 24 weeks	—

Secondary

Measure	Time frame
1. MTX-PG levels at 12 and 24 weeks 2. DAS28CRP improvement from baseline (delta DAS28CRP) > 1.2 at 12 and 24 weeks 3. MTX-PG levels at 0, 1 and 6 hours 4. Radiological remission rate 5. Adverse event rate	—

Countries

Japan

Contacts

Public ContactKatsuya Nagatani

Jichi Medical University Division of Rheumatology and Clinical Immunology, Department of Medicine

knagatani@jichi.ac.jp0285-58-7358

Outcome results