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Trial record 17 of 17 for:    "Bone Disease" | "Sulfasalazine"

Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis (MONITOR)

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ClinicalTrials.gov Identifier: NCT03531073
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment
Psoriatic Arthritis Drug: Methotrexate

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre Observational Psoriatic Arthritis Cohort Study Addressing Real-life Outcomes of a Treat to Target Approach in Routine Clinical Practice.
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Psoriatic arthritis disease activity score (PASDAS) [ Time Frame: 48 weeks ]
    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.


Secondary Outcome Measures :
  1. Psoriatic Arthritis Impact of Disease (PsAID) [ Time Frame: 48 weeks ]
    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.

  2. Treatment satisfaction questionnaire for medications (TSQM) [ Time Frame: 48 weeks ]
    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.

  3. Healthcare costs [ Time Frame: 48 weeks ]

    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.


  4. Health related quality of life [ Time Frame: 48 weeks ]
    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.


Biospecimen Retention:   Samples With DNA
An optional substudy will collect biological samples for research purposes


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients diagnosed with psoriatic arthritis who have not previously had treatment with disease modifying therapy.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531073


Contacts
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Contact: Laura C Coates, MBChB, PhD +447870257823 laura.coates@ndorms.ox.ac.uk
Contact: Marion E Watson +441865737905 marion.watson@ndorms.ox.ac.uk

Locations
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United Kingdom
Oxford University Hospitals NHS Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LD
Contact: Laura C Coates, MBChB    01865737838    laura.coates@ndorms.ox.ac.uk   
Contact: Marion Watson    01865737905    marion.watson@ndorms.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
National Institute for Health Research, United Kingdom

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03531073     History of Changes
Other Study ID Numbers: 230600
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Oxford:
treat to target
Additional relevant MeSH terms:
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Bone Diseases
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors