Rheumatoid ArthritisMIRANCT03913728
Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback
A study testing Drug level blood tests and Telephone Interview in people with Rheumatoid Arthritis, run by University of Manchester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Drug level blood tests and Telephone Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribed oral MTX for ≥ two years
- Clinical diagnosis of RA
- Have a telephone
- Male or female aged 18 years or above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Drug level blood tests, Telephone Interview
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug level blood testsOther
All information included previously.
Telephone InterviewOther
All information included previously.
| Study group | Role | What they receive |
|---|---|---|
| Outcome of blood test provided | Experimental | 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. Receives: Other: Drug level blood tests |
| Outcome of blood test not provided | No intervention | The blood results for these people are not fed back to the patient or the clinical site. |
| Patients have a telephone interview | Experimental | All patients are randomised for a second time; 20% (10) of them will have a semi-structured phone interview Receives: Other: Telephone Interview |
| No telephone interview | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Power for full randomized controlled trial
Change in proportion of people who adhere over 3 months
Measured: 3 months
Patient opinion of HPLC-SRM-MS guided intervention using semi-structured interviewing
Measured: 1 year
Patient opinion of process of research, including outcome measures using semi-structured patient interviewing
Measured: 1 year
Number of patients correctly having intervention according to allocation
Measured: 1 year
Recruitment time
Length of time study needs to run for to recruit all participants
Measured: 1 year
Number of patients invited to take part in the study and number of patients recruited
Measured: 1 year
Withdrawal rate
Measured: 1 year
Trial cost
Measured: 1 year
Secondary outcomes (3)
Biochemical adherence
MTX quantified with HPLC-SRM-MS from serum.
Measured: 1 year
DAS-28 at baseline and 3 months
The disease activity score-28 (DAS-28), range 2-10, higher values represent worse disease activity.
Measured: 1 year
Quantity of patient encounters
Number of patient encounters with healthcare professionals per patient.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start24 May 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. James Bluett, University of Manchester
- Investigators
- James Bluett, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913728
- Sponsor's protocol ID
- NHS001485
- Acronym
- MIRA
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2019
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable patient information will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03913728
- Acronym / sponsor ID
- MIRA / NHS001485
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
| Arm | Type | Receives |
|---|---|---|
| Outcome of blood test provided | Experimental | Other: Drug level blood testsThese 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. |
| Outcome of blood test not provided | No intervention | –The blood results for these people are not fed back to the patient or the clinical site. |
| Patients have a telephone interview | Experimental | Other: Telephone InterviewAll patients are randomised for a second time; 20% (10) of them will have a semi-structured phone interview |
| No telephone interview | No intervention | –All patients are randomised for a second time; 80% won't have a phone call and this will be as per standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prescribed oral MTX for ≥ two years
- Clinical diagnosis of RA
- Have a telephone
- Male or female aged 18 years or above
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug level blood testsAll information included previously. | Other | Outcome of blood test provided |
| Telephone InterviewAll information included previously. | Other | Patients have a telephone interview |
Primary outcome
Power for full randomized controlled trial
Time frame: 3 months
Change in proportion of people who adhere over 3 months
Patient opinion of HPLC-SRM-MS guided intervention using semi-structured interviewing
Time frame: 1 year
Patient opinion of process of research, including outcome measures using semi-structured patient interviewing
Time frame: 1 year
Number of patients correctly having intervention according to allocation
Time frame: 1 year
Recruitment time
Time frame: 1 year
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
Time frame: 1 year
Withdrawal rate
Time frame: 1 year
Trial cost
Time frame: 1 year
3 secondary outcomes
Biochemical adherence
Time frame: 1 year
DAS-28 at baseline and 3 months
Time frame: 1 year
Quantity of patient encounters
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No. No identifiable patient information will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Bluett principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug level blood tests and Telephone Interview in people with Rheumatoid Arthritis, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power for full randomized controlled trial (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.