Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis (MONITOR)
A Multicentre Observational Psoriatic Arthritis Cohort Study Addressing Real-life Outcomes of a Treat to Target Approach in Routine Clinical Practice.
Study Overview
Detailed Description
Psoriatic Arthritis (PsA) is an inflammatory arthritis estimated to occur in 15% of people with psoriasis, affecting around 150,000 people in the United Kingdom (UK). The 2015 European League Against Rheumatism (EULAR) Treatment recommendations for PsA incorporating as its first recommendation that "treatment should be aimed at reaching the target of remission or, alternatively, minimal/low disease activity, by regular monitoring and appropriate adjustment of therapy". Despite the evidence and the EULAR recommendations supporting 'treat to target' in PsA, it has not been widely implemented due to concerns about feasibility and cost-effectiveness. This cohort will establish a pragmatic feasible 'treat to target' approach in a real-life clinic population which we believe can provide similar clinical and health-related quality of life outcomes.
The primary outcome will be the proportion of patients achieving a good response measured by the PsA Disease Activity Score (PASDAS) at 48 weeks. Additional domains including participation, fatigue and emotional wellbeing will be assessed for the first time. Finally the costs of this pragmatic intervention will be established using health economic analysis.All patients will receive treatment as usual following the current British Society of Rheumatology (BSR) and EULAR guidance as standard of care.
As a cohort for a "Trials within Cohorts" or TWiCs design, the patients consenting to participate will also be asked if they consent to be approached for future interventional trials linked to the cohort and whether they consent for their data to be used as a comparator in these future interventional studies.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 7LD
- Oxford University Hospitals NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Standard care cohort
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psoriatic Arthritis Disease Activity Score (PASDAS)
Time Frame: 48 weeks
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A composite measure of PsA disease activity.
This score is a composite measure of disease activity in PsA.
There is only one total score which ranges from 0-10 with higher numbers indicating more active disease.
Low disease activity is defined as <3.2.
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48 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psoriatic Arthritis Impact of Disease (PsAID)
Time Frame: 48 weeks
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A questionnaire assessing the overall impact of disease on a patient.
This is a scale of 12 questions (scored 0-10) which are combined with published weighting scales to one final 0-10 score where 0 is "no impact" and 10 is "maximal impact".
There are no subscales.
Patient acceptable symptom state is <=4.
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48 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Spinal Diseases
- Spondylarthropathies
- Skin Diseases, Papulosquamous
- Skin Diseases
- Spondylarthritis
- Spondylitis
- Psoriasis
- Skin and Connective Tissue Diseases
- Arthritis, Psoriatic
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Pterins
- Pteridines
- Aminopterin
- Methotrexate
Other Study ID Numbers
- 230600
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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