Changes in MTX-PG Concentrations During Subcutaneous MTX Therapy in Patients With Rheumatoid Arthritis(COSMOS Study)

NCT06913907 | Recruiting Phase 4

• 1 other identifier: N20240003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• Change in MTX-PG concentrations in erythrocytes from baseline

  From enrollment to the end of treatment at 24 weeks

Study Arms (1)

MTX group

OTHER

Drug: Methotrexate (MTX)

Interventions

Methotrexate (MTX) DRUG

Single arm study

MTX group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients who were previously untreated with MTX, regardless of route of administration 2) Patients aged \>=18 years at the time of informed consent 3) Patients who meet 2010 EULAR/ACR criteria 4) Patients who have disease activity of SDAI \>11 at screening 5) Patients who were previously untreated with JAK inhibitor or bDMARDs 6) Female of child-bearing potential who can use appropriate contraceptive during the study and for at least one menstrual period after completion of MTX administration, female in whom time from menopause to informed consent is \>=1 year, or female of no child-bearing potential through sterilization 7) Virile male who can use appropriate contraceptive during the study and for at least three months after completion of MTX administration 8) Patients who can adequately understand this study procedures, and voluntarily consent in writing to take part in this study

You may not qualify if:

• \) Pregnant women or women who may be pregnant 2) Patients with a history of hypersensitivity to any ingredient of the study drug 3) Patients with serious hematologic and lymphatic disorders
• Patients with a history of myelodysplastic syndrome, aplastic anemia, or erythroblastoma
• Patients with a diagnosis or treatment of lymphoproliferative disease within the past 5 years
• Patients with significant leukopenia (white blood cell count \<3000/mm3) or thrombocytopenia (platelet count \<50000/mm3millimeter) 4) Patients with significant hepatic impairment
• Patients with acute or chronic active viral hepatitis B or C
• Patients diagnosed with cirrhosis
• Patients with other significant hepatic impairment (AST \>150 U/L or ALT \>150 U/L) 5) Patients with severe renal impairment The following criteria should be used as a reference.
• Dialysis patients or renal dysfunction correspon ding to renal glomerular filtration rate (GFR) \<30 mL/min/1.73 m2 6) Patients who have pleural effusion or ascites 7) Patients who have active tuberculosis 8) Patients otherwise whom principal investigator/sub- investigator considered medically ineligible to participate in the study

Sponsors & Collaborators

• Keio University: lead
• Eisai Co., Ltd.: collaborator
• Mebix Inc: collaborator

Study Sites (1)

Keio University Hospital

Shinjuku-ku, Tokyo, 35 Shinanomachi, Japan

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Kaneko Yuko

CONTACT

+81-3-5363-3786; ykaneko.z6@keio.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)