関節リウマチ患者における皮下MTX療法中のMTX-PG濃度の変化（COSMOS研究）

基本情報

NCT ID

NCT06913907

ステータス

募集中

試験のフェーズ

第4相

試験タイプ

介入

目標被験者数

100

治験依頼者名

Keio University

概要

Methotrexate is known to exist intracellularly as methotrexate polyglutamate, which is formed by the addition of glutamic acid after absorption into the body. The objective of this study is to measure the concentration of methotrexate polyglutamate in red blood cells and peripheral blood mononuclear cells after initiating methotrexate treatment in patients with rheumatoid arthritis who have no prior history of using methotrexate (either subcutaneous or oral formulations). Additionally, we aim to examine changes in methotrexate polyglutamate concentrations when switching from oral methotrexate to subcutaneous Metoject, as well as to investigate the relationship between methotrexate polyglutamate concentration and the efficacy and safety of the treatment. Another objective of this study is to evaluate whether switching to subcutaneous Metoject allows for an increased maximum tolerable dosage while maintaining safety.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)