Psoriatic ArthritisMONITORNCT03531073
Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Methotrexate
- How many people
- 446 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Apr 2018to 31 Dec 2024
- Phase
- Observational
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: Adult patients diagnosed with psoriatic arthritis who have not previously had treatment with disease modifying therapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7LD
About this study
Official title: A Multicentre Observational Psoriatic Arthritis Cohort Study Addressing Real-life Outcomes of a Treat to Target Approach in Routine Clinical Practice.
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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Methotrexate
- Keywords
- treat to target
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriatic Arthritis Disease Activity Score (PASDAS)
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.
Measured: 48 weeks
Secondary outcomes (1)
Psoriatic Arthritis Impact of Disease (PsAID)
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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start18 Apr 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Prospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531073
- Sponsor's protocol ID
- 230600
- Acronym
- MONITOR
- Status last verified
- Dec 2024
- First submitted
- 8 Feb 2018
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rombach I, Tillett W, Jadon D, Tucker L, Watson M, Francis A, Sinomati Y, Eldridge L, Dritsaki M, Dutton SJ, Al-Mossawi H, Gullick N, Thompson B, Coates LC. Treating to target in psoriatic arthritis: assessing real-world outcomes and optimising therapeutic strategy for adults with psoriatic arthritis-study protocol for the MONITOR-PsA study, a trials within cohorts study design. Trials. 2021 Mar 4;22(1):185. doi: 10.1186/s13063-021-05142-7.
PubMed 33663566