Rheumatic DiseasesNCT07512401
Methotrexate Monitoring Target Trial Emulation
An observational study of Rheumatic Diseases, run by Mayo Clinic.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Standard methotrexate lab monitoring and Reduced methotrexate lab monitoring
- How many people
- 2,414 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Incident methotrexate users age ≥18 years in the REP between 1/1/2012-12/31/2022 (to allow at least three years follow-up through analysis date 12/31/2025) with ≥2 preceding codes for rheumatic disease
Who may be able to join
- Incident methotrexate users in rheumatology practice.
Who cannot join
- Hypersensitivity to methotrexate
- Persistent transaminitis 4 weeks prior to study initiation
- Preexisting severe cytopenias or laboratory evidence consistent with immunodeficiency syndromes
- Active malignancy
- Pregnancy
- Breastfeeding patients
About this study
Official title: Safety of Reduced Methotrexate Lab Monitoring: a Population-based, Target Trial Emulation Study
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
Read the detailed description
- Target trial emulation that will include Incident methotrexate users age ≥18 years in the REP between 1/1/2012-12/31/2022 (to allow at least three years follow-up through analysis date 12/31/2025) with ≥2 preceding codes for rheumatic disease
Treatment strategies:
- Guidelines group: monitor 3+ times in first 0-3 months, 3+ times in 3 to 12 months, and at least once every 4.5 months afterward.
- Reduced group: monitor 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).
- Assignment procedures: We will use clone-censor-weighting (CCW) methods to explore the effect of both treatments in each patient. A negative control outcome such as trauma outcomes to assess for uncontrolled confounding.
- Time zero: start date of incident methotrexate use
- Follow up: Ends at methotrexate discontinuation (defined as not taking methotrexate for ≥6 months), death, loss to follow-up, or three years after baseline, whichever occurs first.
Data: Laboratory and prescription data were electronically available since 1/1/2010 and fully viewable since 1/1/2012. Therefore, this study will include all adults aged ≥18 years with incident low-dose (≤25mg/week) methotrexate use from 1/1/2012 on. To ensure the population would fall under the purview of the ACR methotrexate monitoring guidelines, we also required ≥2 codes (30 days apart) for a rheumatic condition within two years prior to index date of first methotrexate prescription, which we ascertained by prescription data and confirmed by manual chart review. A rheumatologist previously manually abstracted all methotrexate monitoring-related data including frequency as described previously (Reed et al., unpublished).
Outcomes:
- Primary outcome is end-organ injury including cirrhosis, severe cytopenia defined by blood product transfusion (RBCs, Plts, G-CSF), or death, all within the follow-up period above. The outcome will be reported as absolute risk per 100 person-years.
- For cirrhosis we will initially use a published code set of ICD-9 and ICD-10 codes with PPV > 50% and then perform blinded, independent validation of outcome and date by chart review.
- Sample size/Power Calculation; A parallel, two-group design (where higher Poisson rates are considered worse) will be used to test whether the Group 2 (treatment) Poisson rate is non-inferior to the Group 1 (control) Poisson rate, with a non-inferiority ratio of 1.5 (H0: λ2 / λ1 ≥ 1.5 versus H1: λ2 / λ1 < 1.5). The comparison will be made using a one-sided, two-sample, Poisson regression term Z-test using the variance calculation method with assumed true rates, with a Type I error rate (α) of 0.025. The dispersion is assumed to be 1. To detect a ratio of Poisson event rates (λ2 / λ1) of 1.25 (λ2 = 0.00413, λ1 = 0.0033), with a sample size of 1500 subjects in Group 1 and 1100 subjects in Group 2, with average exposure time 4, the power is 0.08092. The power was computed using PASS 2025, version 25.0.2. Anticipating a 20% dropout rate, 1875 subjects should be enrolled in Group 1, and 1375 in Group 2, to obtain final group sample sizes of 1500 and 1100, respectively.
- Missing data: Multiple imputation with predictive mean matching will be implemented for baseline data that are assumed missing at random (allows for inclusion of key predictors of both missingness and outcomes).26 Median/modal values of the multiple imputed values will be used for single imputation purposes.
Analysis plan:
- Estimate per-protocol effect via comparison of outcome under each treatment strategy using CCW estimation approach, adjusting for baseline confounders alone. Under the CCW estimation approach, we will only be able to estimate the per-protocol effect of reduced monitoring.
- noninferiority margin: We will survey all co-authors and use their mean answer for tolerable increased absolute risk per 100 person-years of end-organ injury or death to justify the benefits of reduced monitoring (e.g., reduced methotrexate avoidance, cost, time, iatrogenic harm) as the noninferiority margin. We will use one-sided alpha of 0.025
- Normally distributed continuous variables will be compared using t-tests, non-normally distributed continuous variables using the Wilcoxon rank sum tests, and categorical variables using the chi-squared or Fisher's exact tests (for variables with low cell sizes), as appropriate.
- Sensitivity analyses will be conducted for negative control outcome, patients on methotrexate monotherapy, no preceding cirrhosis, an eGFR of < 45 mL/min, based on creatinine with CKD-EPI equation calculation, defining cytopenia using CIRT definition of Hgb <8, plt <50, or WBC <2.9, serum albumin of < 3.0 g/dL (30g/L)
- Conditions
- Rheumatic Diseases
- Being tested
- Standard methotrexate lab monitoring, Reduced methotrexate lab monitoring
- Keywords
- methotrexate, monitoring, target trial
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard methotrexate lab monitoringDiagnostic test
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 monitoringDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard (guidelines) monitoring | The group which has undergone a standard frequency of methotrexate lab monitoring Receives: Diagnostic Test: Standard methotrexate lab monitoring | |
| Reduced monitoring | The group which has undergone a reduced frequency of methotrexate lab monitoring compared to the standard group Receives: Diagnostic Test: Reduced methotrexate lab monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Primary outcome is end-organ injury including cirrhosis, severe cytopenia defined by blood product transfusion (RBCs, Plts, G-CSF), or death, all within the follow-up period above.
The outcome will be reported as absolute risk per 100 person-years
Measured: From baseline until methotrexate discontinuation, death or loss to follow-up, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Jan 2012
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Rochester Epidemiology Project, National Institute on Aging (NIA), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Cynthia Crowson, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512401
- Sponsor's protocol ID
- 20-008534
- Other IDs
- AG 058738, UL1TR002377
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual clinical trial participant-level data will not be shared
Publications
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
PubMed 25046131Biostatistics Group UURBRU. GUIDELINES FOR COMPLETING A RESEARCH PROTOCOL FOR OBSERVATIONAL STUDIES 2010
St Sauver JL, Grossardt BR, Yawn BP, Melton LJ 3rd, Rocca WA. Use of a medical records linkage system to enumerate a dynamic population over time: the Rochester epidemiology project. Am J Epidemiol. 2011 May 1;173(9):1059-68. doi: 10.1093/aje/kwq482. Epub 2011 Mar 23.
PubMed 21430193Hubbard RA, Gatsonis CA, Hogan JW, Hunter DJ, Normand ST, Troxel AB. "Target Trial Emulation" for Observational Studies - Potential and Pitfalls. N Engl J Med. 2024 Nov 28;391(21):1975-1977. doi: 10.1056/NEJMp2407586. Epub 2024 Nov 23. No abstract available.
PubMed 39588897Murray EJ, Hernan MA. Improved adherence adjustment in the Coronary Drug Project. Trials. 2018 Mar 5;19(1):158. doi: 10.1186/s13063-018-2519-5.
PubMed 29506561Heymans MW, Twisk JWR. Handling missing data in clinical research. J Clin Epidemiol. 2022 Nov;151:185-188. doi: 10.1016/j.jclinepi.2022.08.016. Epub 2022 Sep 21.
PubMed 36150546Kahan BC, Jairath V, Dore CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Trials. 2014 Apr 23;15:139. doi: 10.1186/1745-6215-15-139.
PubMed 24755011Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.
PubMed 23268518Lapointe-Shaw L, Georgie F, Carlone D, Cerocchi O, Chung H, Dewit Y, Feld JJ, Holder L, Kwong JC, Sander B, Flemming JA. Identifying cirrhosis, decompensated cirrhosis and hepatocellular carcinoma in health administrative data: A validation study. PLoS One. 2018 Aug 22;13(8):e0201120. doi: 10.1371/journal.pone.0201120. eCollection 2018.
PubMed 30133446Guo J, Wang T, Liu Z, Zeng W, Shen P, Sun Y, Zhan S, Xu Y. Estimating cardiovascular effects of influenza vaccination in older adults: a target trial emulation using proximal causal inference. EClinicalMedicine. 2025 Aug 21;87:103449. doi: 10.1016/j.eclinm.2025.103449. eCollection 2025 Sep.
PubMed 40896461Zhao SS, Lyu H, Solomon DH, Yoshida K. Improving rheumatoid arthritis comparative effectiveness research through causal inference principles: systematic review using a target trial emulation framework. Ann Rheum Dis. 2020 Jul;79(7):883-890. doi: 10.1136/annrheumdis-2020-217200. Epub 2020 May 7.
PubMed 32381560Cashin AG, Hansford HJ, Hernan MA, Swanson SA, Lee H, Jones MD, Dahabreh IJ, Dickerman BA, Egger M, Garcia-Albeniz X, Golub RM, Islam N, Lodi S, Moreno-Betancur M, Pearson SA, Schneeweiss S, Sharp MK, Sterne JAC, Stuart EA, McAuley JH. Transparent Reporting of Observational Studies Emulating a Target Trial-The TARGET Statement. JAMA. 2025 Sep 23;334(12):1084-1093. doi: 10.1001/jama.2025.13350.
PubMed 40899949Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.
PubMed 40294953St Sauver JL, Grossardt BR, Yawn BP, Melton LJ 3rd, Pankratz JJ, Brue SM, Rocca WA. Data resource profile: the Rochester Epidemiology Project (REP) medical records-linkage system. Int J Epidemiol. 2012 Dec;41(6):1614-24. doi: 10.1093/ije/dys195. Epub 2012 Nov 18.
PubMed 23159830Hernan MA. Methods of Public Health Research - Strengthening Causal Inference from Observational Data. N Engl J Med. 2021 Oct 7;385(15):1345-1348. doi: 10.1056/NEJMp2113319. Epub 2021 Oct 2. No abstract available.
PubMed 34596980
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Reduced Methotrexate Lab Monitoring: a Population-based, Target Trial Emulation Study
- ClinicalTrials.gov ID
- NCT07512401
- Acronym / sponsor ID
- 20-008534
- Conditions
- Rheumatic Diseases
- Keywords
- methotrexate, monitoring, target trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,414 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Rochester Epidemiology Project, National Institute on Aging (NIA), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- Target trial emulation that will include Incident methotrexate users age ≥18 years in the REP between 1/1/2012-12/31/2022 (to allow at least three years follow-up through analysis date 12/31/2025) with ≥2 preceding codes for rheumatic disease
Treatment strategies:
- Guidelines group: monitor 3+ times in first 0-3 months, 3+ times in 3 to 12 months, and at least once every 4.5 months afterward.
- Reduced group: monitor 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).
- Assignment procedures: We will use clone-censor-weighting (CCW) methods to explore the effect of both treatments in each patient. A negative control outcome such as trauma outcomes to assess for uncontrolled confounding.
- Time zero: start date of incident methotrexate use
- Follow up: Ends at methotrexate discontinuation (defined as not taking methotrexate for ≥6 months), death, loss to follow-up, or three years after baseline, whichever occurs first.
Data: Laboratory and prescription data were electronically available since 1/1/2010 and fully viewable since 1/1/2012. Therefore, this study will include all adults aged ≥18 years with incident low-dose (≤25mg/week) methotrexate use from 1/1/2012 on. To ensure the population would fall under the purview of the ACR methotrexate monitoring guidelines, we also required ≥2 codes (30 days apart) for a rheumatic condition within two years prior to index date of first methotrexate prescription, which we ascertained by prescription data and confirmed by manual chart review. A rheumatologist previously manually abstracted all methotrexate monitoring-related data including frequency as described previously (Reed et al., unpublished).
Outcomes:
- Primary outcome is end-organ injury including cirrhosis, severe cytopenia defined by blood product transfusion (RBCs, Plts, G-CSF), or death, all within the follow-up period above. The outcome will be reported as absolute risk per 100 person-years.
- For cirrhosis we will initially use a published code set of ICD-9 and ICD-10 codes with PPV > 50% and then perform blinded, independent validation of outcome and date by chart review.
- Sample size/Power Calculation; A parallel, two-group design (where higher Poisson rates are considered worse) will be used to test whether the Group 2 (treatment) Poisson rate is non-inferior to the Group 1 (control) Poisson rate, with a non-inferiority ratio of 1.5 (H0: λ2 / λ1 ≥ 1.5 versus H1: λ2 / λ1 < 1.5). The comparison will be made using a one-sided, two-sample, Poisson regression term Z-test using the variance calculation method with assumed true rates, with a Type I error rate (α) of 0.025. The dispersion is assumed to be 1. To detect a ratio of Poisson event rates (λ2 / λ1) of 1.25 (λ2 = 0.00413, λ1 = 0.0033), with a sample size of 1500 subjects in Group 1 and 1100 subjects in Group 2, with average exposure time 4, the power is 0.08092. The power was computed using PASS 2025, version 25.0.2. Anticipating a 20% dropout rate, 1875 subjects should be enrolled in Group 1, and 1375 in Group 2, to obtain final group sample sizes of 1500 and 1100, respectively.
- Missing data: Multiple imputation with predictive mean matching will be implemented for baseline data that are assumed missing at random (allows for inclusion of key predictors of both missingness and outcomes).26 Median/modal values of the multiple imputed values will be used for single imputation purposes.
Analysis plan:
- Estimate per-protocol effect via comparison of outcome under each treatment strategy using CCW estimation approach, adjusting for baseline confounders alone. Under the CCW estimation approach, we will only be able to estimate the per-protocol effect of reduced monitoring.
- noninferiority margin: We will survey all co-authors and use their mean answer for tolerable increased absolute risk per 100 person-years of end-organ injury or death to justify the benefits of reduced monitoring (e.g., reduced methotrexate avoidance, cost, time, iatrogenic harm) as the noninferiority margin. We will use one-sided alpha of 0.025
- Normally distributed continuous variables will be compared using t-tests, non-normally distributed continuous variables using the Wilcoxon rank sum tests, and categorical variables using the chi-squared or Fisher's exact tests (for variables with low cell sizes), as appropriate.
- Sensitivity analyses will be conducted for negative control outcome, patients on methotrexate monotherapy, no preceding cirrhosis, an eGFR of < 45 mL/min, based on creatinine with CKD-EPI equation calculation, defining cytopenia using CIRT definition of Hgb <8, plt <50, or WBC <2.9, serum albumin of < 3.0 g/dL (30g/L)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard (guidelines) monitoring | – | Diagnostic Test: Standard methotrexate lab monitoringThe group which has undergone a standard frequency of methotrexate lab monitoring |
| Reduced monitoring | – | Diagnostic Test: Reduced methotrexate lab monitoringThe group which has undergone a reduced frequency of methotrexate lab monitoring compared to the standard group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incident methotrexate users age ≥18 years in the REP between 1/1/2012-12/31/2022 (to allow at least three years follow-up through analysis date 12/31/2025) with ≥2 preceding codes for rheumatic disease
Key inclusion criteria (1 listed)
- Incident methotrexate users in rheumatology practice.
Key exclusion criteria (6 listed)
- Hypersensitivity to methotrexate
- Persistent transaminitis 4 weeks prior to study initiation
- Preexisting severe cytopenias or laboratory evidence consistent with immunodeficiency syndromes
- Active malignancy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard methotrexate lab monitoringThis 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 | Standard (guidelines) monitoring |
| Reduced methotrexate lab monitoringThis 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). | Diagnostic test | Reduced monitoring |
Primary outcome
Primary Outcome
Time frame: From baseline until methotrexate discontinuation, death or loss to follow-up, assessed up to 3 years.
Primary outcome is end-organ injury including cirrhosis, severe cytopenia defined by blood product transfusion (RBCs, Plts, G-CSF), or death, all within the follow-up period above. The outcome will be reported as absolute risk per 100 person-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 25046131von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
- BackgroundBiostatistics Group UURBRU. GUIDELINES FOR COMPLETING A RESEARCH PROTOCOL FOR OBSERVATIONAL STUDIES 2010
- Background: PubMed 21430193St Sauver JL, Grossardt BR, Yawn BP, Melton LJ 3rd, Rocca WA. Use of a medical records linkage system to enumerate a dynamic population over time: the Rochester epidemiology project. Am J Epidemiol. 2011 May 1;173(9):1059-68. doi: 10.1093/aje/kwq482. Epub 2011 Mar 23.
- Background: PubMed 39588897Hubbard RA, Gatsonis CA, Hogan JW, Hunter DJ, Normand ST, Troxel AB. "Target Trial Emulation" for Observational Studies - Potential and Pitfalls. N Engl J Med. 2024 Nov 28;391(21):1975-1977. doi: 10.1056/NEJMp2407586. Epub 2024 Nov 23. No abstract available.
- Background: PubMed 29506561Murray EJ, Hernan MA. Improved adherence adjustment in the Coronary Drug Project. Trials. 2018 Mar 5;19(1):158. doi: 10.1186/s13063-018-2519-5.
- Background: PubMed 36150546Heymans MW, Twisk JWR. Handling missing data in clinical research. J Clin Epidemiol. 2022 Nov;151:185-188. doi: 10.1016/j.jclinepi.2022.08.016. Epub 2022 Sep 21.
- Background: PubMed 24755011Kahan BC, Jairath V, Dore CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Trials. 2014 Apr 23;15:139. doi: 10.1186/1745-6215-15-139.
- Background: PubMed 23268518Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.
- Background: PubMed 30133446Lapointe-Shaw L, Georgie F, Carlone D, Cerocchi O, Chung H, Dewit Y, Feld JJ, Holder L, Kwong JC, Sander B, Flemming JA. Identifying cirrhosis, decompensated cirrhosis and hepatocellular carcinoma in health administrative data: A validation study. PLoS One. 2018 Aug 22;13(8):e0201120. doi: 10.1371/journal.pone.0201120. eCollection 2018.
- Background: PubMed 40896461Guo J, Wang T, Liu Z, Zeng W, Shen P, Sun Y, Zhan S, Xu Y. Estimating cardiovascular effects of influenza vaccination in older adults: a target trial emulation using proximal causal inference. EClinicalMedicine. 2025 Aug 21;87:103449. doi: 10.1016/j.eclinm.2025.103449. eCollection 2025 Sep.
- Background: PubMed 32381560Zhao SS, Lyu H, Solomon DH, Yoshida K. Improving rheumatoid arthritis comparative effectiveness research through causal inference principles: systematic review using a target trial emulation framework. Ann Rheum Dis. 2020 Jul;79(7):883-890. doi: 10.1136/annrheumdis-2020-217200. Epub 2020 May 7.
- Background: PubMed 40899949Cashin AG, Hansford HJ, Hernan MA, Swanson SA, Lee H, Jones MD, Dahabreh IJ, Dickerman BA, Egger M, Garcia-Albeniz X, Golub RM, Islam N, Lodi S, Moreno-Betancur M, Pearson SA, Schneeweiss S, Sharp MK, Sterne JAC, Stuart EA, McAuley JH. Transparent Reporting of Observational Studies Emulating a Target Trial-The TARGET Statement. JAMA. 2025 Sep 23;334(12):1084-1093. doi: 10.1001/jama.2025.13350.
- Individual participant dataSharing planned: No. individual clinical trial participant-level data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: From baseline until methotrexate discontinuation, death or loss to follow-up, assessed up to 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07512401, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.