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Completed

NCT Number: NCT03913728

Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennine MSK

Oldham, Lancashire, OL1 1NL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prescribed oral MTX for ≥ two years
  • Clinical diagnosis of RA
  • Have a telephone
  • Male or female aged 18 years or above

Exclusion criteria

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

Treatment and study plan

Drug level blood tests

Other

All information included previously.

telephone interview

Other

All information included previously.

Primary outcomes

  1. Power for full randomized controlled trial

    Time frame: 3 months

    Change in proportion of people who adhere 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback: A Feasibility Trial

Acronym: MIRA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2019
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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