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Completed
NCT03531073
Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis
Conditions: Psoriatic Arthritis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 446
Sponsor: University of Oxford
Location: Oxford University Hospitals NHS Trust Oxford Oxfordshire
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.
Eligibility Criteria
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female
* Aged 18 years or above.
* Clinical diagnosis of PsA based upon the Classification of PsA (CASPAR) criteria(23))
* Active PsA defined by ≥1 tender or ≥1 swollen joint or ≥1 enthesis (site of attachment of tendon to bone)
* Not previously received treatment with synthetic or biologic disease-modifying anti-rheumatic drugs (DMARDs) for their articular disease.
* In the Investigator's opinion, is able and willing to comply with all study requirements.
Exclusion Criteria:
* Current or previous treatment of arthritis with synthetic DMARDs (including methotrexate, leflunomide or sulfasalazine) or biologic DMARDs (including tumour necrosis factor (TNF), interleukin (IL)12/23 or IL17 inhibitor therapies) or targeted synthetic DMARDs (phosphodiesterase (PDE) 4 or Janus kinase (JAK) inhibitor therapies).
* Use of investigational therapies within 1 month or 5 biological half-lives of the baseline study visit(whichever is longer)
* Women who are pregnant, nursing or planning pregnancy during the following 12 months.
Source: ClinicalTrials.gov (NCT03531073). StuddyBuddy aggregates publicly available trial information.