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New treatment option for Rheumatoid Arthritis (RA)
Official title Changes in MTX-PG Concentrations During Subcutaneous MTX Therapy in Patients With Rheumatoid Arthritis(COSMOS Study)
ClinicalTrials.gov ID: NCT06913907
What this study is testing
What is Methotrexate (MTX)?
Methotrexate (MTX) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1) Patients who were previously untreated with MTX, regardless of route of administration 2) Patients aged \>=18 years at the time of informed...
You likely can't join if
- 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...
- 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...
- Patients with acute or chronic active viral hepatitis B or C
- Patients diagnosed with cirrhosis
See the full eligibility 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shinjuku-ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shinjuku-ku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.