Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback

Rheumatoid Arthritis Clinical Trial

— MIRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913728
• Other study ID #: NHS001485
• Status: Completed
• Phase: N/A
• Start date: May 24, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Drug level blood tests
All information included previously.
• Telephone Interview
All information included previously.

Locations

Country	Name	City	State
United Kingdom	Pennine MSK	Oldham	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Power for full randomized controlled trial	Change in proportion of people who adhere over 3 months	3 months
Primary	Patient opinion of HPLC-SRM-MS guided intervention using semi-structured interviewing		1 year
Primary	Patient opinion of process of research, including outcome measures using semi-structured patient interviewing		1 year
Primary	Number of patients correctly having intervention according to allocation		1 year
Primary	Recruitment time	Length of time study needs to run for to recruit all participants	1 year
Primary	Number of patients invited to take part in the study and number of patients recruited		1 year
Primary	Withdrawal rate		1 year
Primary	Trial cost		1 year
Secondary	Biochemical adherence	MTX quantified with HPLC-SRM-MS from serum.	1 year
Secondary	DAS-28 at baseline and 3 months	The disease activity score-28 (DAS-28), range 2-10, higher values represent worse disease activity.	1 year
Secondary	Quantity of patient encounters	Number of patient encounters with healthcare professionals per patient.	1 year