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Methotrexate Use Improvement in Rheumatoid Arthritis Using Biomarker Feedback

NCT03913728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-10-30

No results posted yet for this study

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

Interventions

OTHER

Drug level blood tests

All information included previously.

OTHER

Telephone Interview

All information included previously.

Sponsors & Collaborators

  • University of Manchester

    lead OTHER

Principal Investigators

  • James Bluett · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-24
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03913728 on ClinicalTrials.gov