CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,414 enrolled
Drug / intervention
Standard methotrexate lab monitoring +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07512401
NCT07512401N/ACompleted

Safety of Reduced Methotrexate Lab Monitoring: a Population-based, Target Trial Emulation Study

Mayo Clinic·observational·Posted Apr 6, 2026·Updated Apr 6, 2026

In Brief

An observational study evaluating Standard methotrexate lab monitoring and Reduced methotrexate lab monitoring for Rheumatic Diseases. Completed, enrolled 2,414 participants.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2026
Enrollment StartJan 1, 2012
Primary CompletionDec 31, 2025
TodayJul 2, 2026
Enrollment to primary: 14 yearsPosted 3 months ago

Interventions

Standard methotrexate lab monitoringother

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.

Reduced methotrexate lab monitoringother

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).