Measuring Methotrexate Levels in Rheumatoid Arthritis Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to measure the concentration of methotrexate polyglutamate in red blood cells and peripheral blood mononuclear cells in patients with rheumatoid arthritis who have not previously used methotrexate. It will also evaluate changes in these concentrations when switching from oral methotrexate to subcutaneous Metoject. Additionally, the study will investigate the relationship between methotrexate polyglutamate levels and the efficacy and safety of the treatment, as well as the potential for increased maximum tolerable dosages with subcutaneous administration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\) 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

Exclusion Criteria:

* 1\) 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

Where it's running

• Keio University Hospital
  Shinjuku-ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Kaneko Yuko
• Email: ykaneko.z6@keio.jp
• Phone: +81-3-5363-3786

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Subcutaneous methotrexate for Chinese adults with rheumatoid arthritis

  This project will test how well and how safely subcutaneous methotrexate works for Chinese adults with rheumatoid arthritis, including people with lung or coronary comorbidities.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07463937

• Evaluating the effects of oral AP1189 in early rheumatoid arthritis patients

  This study is testing if a new oral medication called AP1189 can help people with early rheumatoid arthritis feel better when taken with methotrexate.

  Recruiting at 11 sites Phase 2 SynAct Pharma Aps · Cutler Bay, Florida and 10 other locations · NCT06671054

• Heart Rate Variability and Rheumatoid Arthritis: What HRV Looks Like with RA

  This study checks whether continuous HRV data from an Oura ring can reflect RA disease activity in adults with RA.

  Recruiting University of Central Florida · Orlando, Florida · NCT07878975

• Discontinuing MTX or LEF in RA Patients on TNF Inhibitors

  This trial tests whether stopping methotrexate or leflunomide while continuing a TNF inhibitor is not worse for disease control in adults with rheumatoid arthritis.

  Recruiting Phase 4 Sint Maartenskliniek · Nijmegen, Gelderland and 3 other locations · NCT07802678

• FT839 therapy for autoimmune diseases

  This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.

  Recruiting Phase 1/2 Fate Therapeutics · Fullerton, California · NCT07800871

• 24-Hour Movement and Atherosclerotic Risk in adults with rheumatoid arthritis

  This study tests how daily activity, sitting, and sleep relate to heart-related risk in adults with RA, using wearables and follow-up after a year.

  Recruiting São Paulo State University · Presidente Prudente, São Paulo · NCT07774507

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.