Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback (MIRA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Drug level blood tests
Telephone Interview
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Pennine MSK
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Outcome of blood test provided
Outcome of blood test not provided
Patients have a telephone interview
No telephone interview
Arm Description
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.
The blood results for these people are not fed back to the patient or the clinical site.
All patients are randomised for a second time; 20% (10) of them will have a semi-structured phone interview
All patients are randomised for a second time; 80% won't have a phone call and this will be as per standard care.
Outcomes
Primary Outcome Measures
Power for full randomized controlled trial
Change in proportion of people who adhere over 3 months
Patient opinion of HPLC-SRM-MS guided intervention using semi-structured interviewing
Patient opinion of process of research, including outcome measures using semi-structured patient interviewing
Number of patients correctly having intervention according to allocation
Recruitment time
Length of time study needs to run for to recruit all participants
Number of patients invited to take part in the study and number of patients recruited
Withdrawal rate
Trial cost
Secondary Outcome Measures
Biochemical adherence
MTX quantified with HPLC-SRM-MS from serum.
DAS-28 at baseline and 3 months
The disease activity score-28 (DAS-28), range 2-10, higher values represent worse disease activity.
Quantity of patient encounters
Number of patient encounters with healthcare professionals per patient.
Full Information
NCT ID
NCT03913728
First Posted
March 28, 2019
Last Updated
December 1, 2022
Sponsor
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT03913728
Brief Title
Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback
Acronym
MIRA
Official Title
Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback: A Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outcome of blood test provided
Arm Type
Experimental
Arm Description
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.
Arm Title
Outcome of blood test not provided
Arm Type
No Intervention
Arm Description
The blood results for these people are not fed back to the patient or the clinical site.
Arm Title
Patients have a telephone interview
Arm Type
Experimental
Arm Description
All patients are randomised for a second time; 20% (10) of them will have a semi-structured phone interview
Arm Title
No telephone interview
Arm Type
No Intervention
Arm Description
All patients are randomised for a second time; 80% won't have a phone call and this will be as per standard care.
Intervention Type
Other
Intervention Name(s)
Drug level blood tests
Intervention Description
All information included previously.
Intervention Type
Other
Intervention Name(s)
Telephone Interview
Intervention Description
All information included previously.
Primary Outcome Measure Information:
Title
Power for full randomized controlled trial
Description
Change in proportion of people who adhere over 3 months
Time Frame
3 months
Title
Patient opinion of HPLC-SRM-MS guided intervention using semi-structured interviewing
Time Frame
1 year
Title
Patient opinion of process of research, including outcome measures using semi-structured patient interviewing
Time Frame
1 year
Title
Number of patients correctly having intervention according to allocation
Time Frame
1 year
Title
Recruitment time
Description
Length of time study needs to run for to recruit all participants
Time Frame
1 year
Title
Number of patients invited to take part in the study and number of patients recruited
Time Frame
1 year
Title
Withdrawal rate
Time Frame
1 year
Title
Trial cost
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Biochemical adherence
Description
MTX quantified with HPLC-SRM-MS from serum.
Time Frame
1 year
Title
DAS-28 at baseline and 3 months
Description
The disease activity score-28 (DAS-28), range 2-10, higher values represent worse disease activity.
Time Frame
1 year
Title
Quantity of patient encounters
Description
Number of patient encounters with healthcare professionals per patient.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Bluett
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennine MSK
City
Oldham
State/Province
Lancashire
ZIP/Postal Code
OL1 1NL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No identifiable patient information will be shared with other researchers
Learn more about this trial
Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback
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