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Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback (MIRA)

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ClinicalTrials.gov Identifier: NCT03913728
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. James Bluett, University of Manchester

Brief Summary:

The study is a prospective single-centre randomised controlled trial to examine the feasibility of a fully powered randomised controlled trial to examine if HPLC-SRM-MS guided intervention is superior to standard clinical care in improving clinical, behavioural and health-economy outcomes in RA patients prescribed MTX.

The trial will consist of 4 stages:

  • Screening (~-2 weeks)
  • Recruitment, consent, randomisation, data collection, examination and blood sampling - baseline visit 1 (time point 0)
  • Intervention - telephone appointment (visit 2, intervention arm)
  • Outcome - visit 3
  • Process evaluation - visit 4

Prior to any trial specific procedures, the participant must have signed the informed consent form (ICF).

The trial will offer a small financial compensation for successfully recruited patients toward the costs of parking/refreshments/travel costs/inconvenience related to attending visits


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Drug level blood tests Other: Telephone Interview Not Applicable

Detailed Description:

Rheumatoid arthritis (RA) affects up to 1% of the adult population. It is a condition that is treatable by medications. Methotrexate (MTX) is the first-line therapy for RA however, up to 60% of patients prescribed MTX still have active RA. This puts these patients at higher risk of joint damage compared to those whose RA is under control.

One important explanation for the poor control in those who receive treatment is that some patients, for many reasons, do not take their medications as recommended (non-adherence). Non-adherence is associated with increased costs to the NHS and reduced response to MTX.

The study will assess whether it is achievable to conduct a much larger study to explore whether a review of how well patients are coping with MTX can improve RA control. Understanding the reasons for poor RA control has the potential to improve the health and well-being of individual patients, avoid unnecessary tests and hospital appointments and save money in healthcare.

The trial will recruit 50 patients with RA who have been prescribed MTX for more than 2 years. 25 patients will be asked to donate blood samples and complete questionnaires, but their treatment will continue as standard. The blood tests will include patients MTX levels. The results of the test provide a direct measure of medication adherence. For the other 25 patients, the results of the blood tests will be fed back to them with tailored targeting of the main reason(s) for the deviation from the prescribed MTX. At the end of the study, the investigators will assess the feasibility of a randomised controlled trial of a biochemical screening of adherence guided intervention in patients with RA treated with MTX.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback: A Feasibility Trial
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Outcome of blood test provided
These patients are given the results of their drug level blood tests and treatment can be altered/ further advice can be provided as a result of this.
Other: Drug level blood tests
All information included previously.

No Intervention: Outcome of blood test not provided
The blood results for these people are not fed back to the patient or the clinical site.
Experimental: Patients have a telephone interview
All patients are randomised for a second time; 20% (10) of them will have a semi-structured phone interview
Other: Telephone Interview
All information included previously.

No Intervention: No telephone interview
All patients are randomised for a second time; 80% won't have a phone call and this will be as per standard care.



Primary Outcome Measures :
  1. Power for full randomized controlled trial [ Time Frame: 3 months ]
    Change in proportion of adherers over 3 months

  2. Patient opinion of HPLC-SRM-MS guided intervention using semi-structured interviewing [ Time Frame: 1 year ]
  3. Patient opinion of process of research, including outcome measures using semi-structured patient interviewing [ Time Frame: 1 year ]
  4. Number of patients correctly having intervention according to allocation [ Time Frame: 1 year ]
  5. Recruitment time [ Time Frame: 1 year ]
    Length of time study needs to run for to recruit all participants

  6. Number of patients invited to take part in the study and number of patients recruited [ Time Frame: 1 year ]
  7. Withdrawal rate [ Time Frame: 1 year ]
  8. Trial cost [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Biochemical adherence [ Time Frame: 1 year ]
    MTX quantified with HPLC-SRM-MS from serum.

  2. DAS-28 at baseline and 3 months [ Time Frame: 1 year ]
    The disease activity score-28 (DAS-28), range 2-10, higher values represent worse disease activity.

  3. Quantity of patient encounters [ Time Frame: 1 year ]
    Number of patient encounters with healthcare professionals per patient.



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
Criteria

Inclusion Criteria:

  1. Prescribed oral MTX for ≥ two years
  2. Clinical diagnosis of RA
  3. Have a telephone
  4. Male or female aged 18 years or above

Exclusion Criteria:

  1. Patients with significant psychiatric illness as determined by the clinician
  2. Patients unable to attend second appointment
  3. Patients unable to provide informed consent
  4. Patients with recent changes in the prescribed anti-rheumatic medications within 2 weeks of visit 1
  5. Unable to speak English and complete questionnaires

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): NCT03913728


Contacts
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Contact: James Bluett 0161 275 1614 james.bluett@manchester.ac.uk
Contact: Sarah Ashton 0161 306 0539 sarah.ashton-2@manchester.ac.uk

Locations
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United Kingdom
Pennine MSK Recruiting
Oldham, Lancashire, United Kingdom, OL1 1NL
Contact: James Bluett    0161 621 3838    james.bluett@manchester.ac.uk   
Sponsors and Collaborators
University of Manchester
Investigators
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Principal Investigator: James Bluett University of Manchester

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Responsible Party: Dr. James Bluett, Clinical Senior Lecturer, University of Manchester
ClinicalTrials.gov Identifier: NCT03913728     History of Changes
Other Study ID Numbers: NHS001485
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No identifiable patient information will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System 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