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Methotrexate Monitoring Target Trial Emulation

NCT07512401 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2414

Last updated 2026-04-06

No results posted yet for this study

Summary

The goal of this retrospective, observational study is to learn more about the risks and benefits of methotrexate lab monitoring. The main question it aims to answer is:

\- Is reduced methotrexate lab monitoring non-inferiorly safe when compared to standard lab monitoring?

Differences in end-organ damage and/or death will be compared between participants who have previously been treated with methotrexate for various rheumatic diseases and have undergone varying intervals of methotrexate lab monitoring

Conditions

  • Rheumatic Diseases

Interventions

DIAGNOSTIC_TEST

Standard methotrexate lab monitoring

This group will undergo standard or guidelines based frequency of methotrexate lab monitoring, defined as lab monitoring 3+ times in first 0-3 months, 3+ times in 3 to 12 months, and at least once every 4.5 months afterward.

DIAGNOSTIC_TEST

Reduced methotrexate lab monitoring

This group will undergo reduced frequency of methotrexate lab monitoring, defined as lab monitoring 1-2 times in first 0-3 months, 1-2 times in 3 to 12 months, and at least once per year afterward (but not more than once every 4.5 months).

Sponsors & Collaborators

  • Rochester Epidemiology Project

    collaborator UNKNOWN

  • National Institute on Aging (NIA)

    collaborator NIH

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512401 on ClinicalTrials.gov