CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 446 enrolled / 446 target
Drug / intervention
Methotrexatedrug
Likely dose
15mgfrom 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/NCT03531073
NCT03531073N/ACompletedHigh Momentum (4.5/mo)Completion was 18mo ago

A Multicentre Observational Psoriatic Arthritis Cohort Study Addressing Real-life Outcomes of a Treat to Target Approach in Routine Clinical Practice.

University of Oxford·observational·Posted May 21, 2018·Updated Jun 22, 2026

In Brief

An observational study evaluating Methotrexate for Psoriatic Arthritis. Completed, enrolled 446 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

MONITOR is a cohort study recruiting patients with a new diagnosis of psoriatic arthritis (PsA) which will establish outcomes using a pragmatic feasible 'treat to target' approach in a real-life clinic population. It is the central cohort for a planned Trials Within Cohorts (TWiCs) design which will test alternative therapies and interventions in embedded clinical trials comparing outcomes to those receiving "standard care" in the cohort.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 21, 2018
Enrollment StartApr 18, 2018
Primary CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 8.1 years ago

Arms & Interventions

Standard care cohortother

This study is observational. Patients will receive standard treatment as given in usual clinical practice with no intervention as part of the study. As per current clinical practice guidelines and UK reimbursement rules for biologics in PsA, patients will receive a pragmatic treat to target approach using step up standard therapies. Patients will usually receive methotrexate first line, initially 15mg ow increasing to 25mg ow as tolerated. In case of non-response, an additional DMARD will be used (sulfasalazine up to 3g daily or leflunomide 20mg od). If two DMARDs are failed and patients are eligible for biologic therapy under UK National Institute of Health and Clinical Excellence (NICE) guidance, then biologics will be used.

Drug: Methotrexate

Interventions

Methotrexatedrug

This study is observational and patients will receive treatment for their psoriatic arthritis as clinically indicated. As per standard practice in this observational cohort, patients are most likely to be treated with methotrexate as the most common first line therapy in PsA. This cohort is the basis of a TWiCs (Trials Within Cohorts) study design and interventional studies will be nested within this in future. Whilst the cohort will receive treatment for their PsA as part of their routine clinical care, this treatment will be decided according to routine care and not protocolised.