Clinical trial NCT03913728: Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback
Official title: Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Power for full randomized controlled trial
timeFrame: 3 months
measure: Patient opinion of HPLC-SRM-MS guided intervention using semi-structured interviewing
timeFrame: 1 year
measure: Patient opinion of process of research, including outcome measures using semi-structured patient interviewing
timeFrame: 1 year
measure: Number of patients correctly having intervention according to allocation
timeFrame: 1 year
measure: Recruitment time
timeFrame: 1 year
measure: Number of patients invited to take part in the study and number of patients recruited
timeFrame: 1 year
measure: Withdrawal rate
timeFrame: 1 year
measure: Trial cost
timeFrame: 1 year
Secondary outcomes:
measure: Biochemical adherence
timeFrame: 1 year
measure: DAS-28 at baseline and 3 months
timeFrame: 1 year
measure: Quantity of patient encounters
timeFrame: 1 year
Other outcomes:
Locations:
city: Oldham
country: United Kingdom
facility: Pennine MSK
state: Lancashire
Study officials:
affiliation: University of Manchester
name: James Bluett
role: PRINCIPAL_INVESTIGATOR
References: