- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03913728
Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback (MIRA)
Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback: A Feasibility Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lancashire
-
Oldham, Lancashire, United Kingdom, OL1 1NL
- Pennine MSK
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Power for full randomized controlled trial
Time Frame: 3 months
|
Change in proportion of people who adhere over 3 months
|
3 months
|
Patient opinion of HPLC-SRM-MS guided intervention using semi-structured interviewing
Time Frame: 1 year
|
1 year
|
|
Patient opinion of process of research, including outcome measures using semi-structured patient interviewing
Time Frame: 1 year
|
1 year
|
|
Number of patients correctly having intervention according to allocation
Time Frame: 1 year
|
1 year
|
|
Recruitment time
Time Frame: 1 year
|
Length of time study needs to run for to recruit all participants
|
1 year
|
Number of patients invited to take part in the study and number of patients recruited
Time Frame: 1 year
|
1 year
|
|
Withdrawal rate
Time Frame: 1 year
|
1 year
|
|
Trial cost
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical adherence
Time Frame: 1 year
|
MTX quantified with HPLC-SRM-MS from serum.
|
1 year
|
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.
|
1 year
|
Quantity of patient encounters
Time Frame: 1 year
|
Number of patient encounters with healthcare professionals per patient.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Bluett, University of Manchester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHS001485
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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