Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback

NCT03913728 | Completed DMC

• 1 other identifier: NHS001485
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (8)

• Power for full randomized controlled trial

  Change in proportion of people who adhere over 3 months

  3 months

• Patient opinion of HPLC-SRM-MS guided intervention using semi-structured interviewing

  1 year

• Patient opinion of process of research, including outcome measures using semi-structured patient interviewing

  1 year

• Number of patients correctly having intervention according to allocation

  1 year

• Recruitment time

  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

  1 year

• Withdrawal rate

  1 year

• Trial cost

  1 year

Secondary Outcomes (3)

• Biochemical adherence

  1 year

• DAS-28 at baseline and 3 months

  1 year

• Quantity of patient encounters

  1 year

Study Arms (4)

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.

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

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.

Interventions

Drug level blood tests OTHER

All information included previously.

Outcome of blood test provided

Telephone Interview OTHER

All information included previously.

Patients have a telephone interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prescribed oral MTX for ≥ two years
• Clinical diagnosis of RA
• Have a telephone
• Male or female aged 18 years or above

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Pennine MSK

Oldham, Lancashire, OL1 1NL, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• James Bluett

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Senior Lecturer

Model Details: Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 12, 2019
• Study Start: May 24, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)