Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis

NCT03531073 | Completed DMC

• 1 other identifier: 230600
• Study Type: observational
• Target: 446
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriatic Arthritis

Keywords

treat to target

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Psoriatic Arthritis Impact of Disease (PsAID)

  48 weeks

• Treatment satisfaction questionnaire for medications (TSQM)

  48 weeks

• Healthcare costs

  48 weeks

• Health related quality of life

  48 weeks

Study Arms (1)

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.

Drug: Methotrexate

Interventions

Methotrexate DRUG

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.

Standard care cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients diagnosed with psoriatic arthritis who have not previously had treatment with disease modifying therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7LD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33663566 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

An optional substudy will collect biological samples for research purposes

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: May 21, 2018
• Study Start: April 18, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)