Phase 4 Rheumatoid Arthritis Trial, Recruiting NCT06913907 Sponsor: Keio University Condition: Rheumatoid Arthritis
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Phase 4 Rheumatoid Arthritis Trial, Recruiting

NCT06913907
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have never previously been treated with methotrexate (MTX), by any method of taking it
  • People who are 18 years of age or older at the time of signing the consent form
  • People who have been diagnosed with rheumatoid arthritis according to the 2010 EULAR/ACR classification criteria
  • People whose rheumatoid arthritis is measured as moderately to highly active (an SDAI score above 11) at the screening stage
  • People who have never been treated with JAK inhibitors or biological disease-modifying drugs (bDMARDs) (confirm with trial site if unsure which medications these include)
  • Women of childbearing potential who are able to use appropriate contraception during the study and for at least one menstrual period after finishing MTX treatment
  • Women who have been through menopause for at least one year before signing the consent form, or who are unable to have children due to sterilisation
  • Men who are able to father children and who can use appropriate contraception during the study and for at least three months after finishing MTX treatment
  • People who are able to understand the study procedures and are willing to provide written consent to participate

Who may not be able to join:

  • Women who are pregnant or who may be pregnant
  • People who have had an allergic reaction to any ingredient in the study drug
  • People with a history of certain serious blood or lymphatic conditions, such as myelodysplastic syndrome, aplastic anaemia, or erythroblastoma
  • People who have been diagnosed with or treated for a lymphoproliferative (lymph system) disease within the past five years
  • People with significantly low white blood cell counts or platelet counts, as measured by specific blood test thresholds
  • People with serious liver problems, including active hepatitis B or C, cirrhosis, or significantly elevated liver enzyme levels (AST or ALT above 150 U/L)
  • People with severe kidney problems, including those on dialysis or with a kidney filtration rate (GFR) below 30 mL/min/1.73m²
  • People who have fluid build-up around the lungs (pleural effusion) or in the abdomen (ascites)
  • People with active tuberculosis
  • People whom the principal investigator considers medically unsuitable to participate for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: +81-3-5363-3786

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Keio University
Registry
ClinicalTrials.gov
Start date
10 April 2025
Est. completion
31 December 2027

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Change in MTX-PG concentrations in erythrocytes from baseline

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov