Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— MONITOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03531073
• Other study ID #: 230600
• Status: Recruiting
• Start date: April 18, 2018
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: University of Oxford
• Contact: Laura C Coates, MBChB, PhD
• Phone: +447870257823
• Email: laura.coates[@]ndorms.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Methotrexate
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.

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Trust	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 weeks
Secondary	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.	48 weeks
Secondary	Treatment satisfaction questionnaire for medications (TSQM)	A questionnaire assessing benefit and tolerability of the treatment given. There are 4 subscales measuring effectiveness (questions 1-3), side effects (questions 4-8), convenience (questions 9-11), and global satisfaction (questions 12-14). Each is scored 0-100 where 100 is good and 0 is bad. The subscales are not combined to one final score.	48 weeks
Secondary	Healthcare costs	Healthcare costs of treatment given will be calculated for the patients within the cohort will be collected at 24 weeks and 48 weeks using self-reported questionnaires. The data collected will record indirect costs as well as direct non-medical costs. This is one measure that will report the healthcare costs for the patients in the cohort. This could be split into subscales of drug costs, healthcare provision costs and costs of investigations.; Unit cost data will be obtained from national databases such as the British National Formulary (BNF) and Personal Social Services Research Unit (PSSRU) Costs of Health and Social Care.	48 weeks
Secondary	Health related quality of life	HRQoL will be calculated using the EuroQol 5 dimension 5 level (EQ-5D-5L) questionnaire which is a generic measure of health related quality of life. This will be collected at baseline, 6 and 12 months and responses to the EQ-5D will be converted into multi-attribute utility scores using an established algorithm. Possible values range from -0.224 to 1 with 0 representing death, 1 representing full health and negative values representing states worse than death. Thus a higher score represents better quality of life.	48 weeks