NCT05697159 7 Tesla MRI Brain Imaging to Decipher Filgotinib's Mode of Analgesic Action in Rheumatoid Arthritis
| NCT ID | NCT05697159 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NHS Greater Glasgow and Clyde |
| Condition | Rheumatoid Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-08-22 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2023-08-22 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an experimental medicine, single-centre, observational test-retest study to evaluate Filgotinib's mechanism of analgesic action in RA patients. The investigators hypothesize that Filgotinib's mechanism of analgesic action is determined by at least two factors. The first is related to those CNS sensitization pathways seen in fibromyalgia, specifically DMN-insula brain functional connectivity and insular glutamate. The second is related to peripheral inflammation, specifically joint synovitis, blood cytokines/chemokines and DAN-LIPL functional brain connectivity. The CNS sensitization pain pathways related to fibromyalgia are more quickly modified compared to those related to peripheral inflammation and help explain Filgotinib's rapid onset of effect.
Eligibility Criteria
Inclusion Criteria: Patients with moderate to severe active RA who have been prescribed filgotinib in line with the Summary of Product Characterisation and are: * Adults ≥18 years \< 75 years. * Right-handed (to reduce neuroimaging heterogeneity). Exclusion Criteria: * Inability to provide written informed consent. * Severe physical impairment (e.g. blindness, deafness, paraplegia). * Pregnant or breast feeding. * Severe claustrophobia precluding MRI. * Contraindications to MRI. * Major confounding neurological disease including MS, Stroke, Traumatic Brain Injury. * Previous targeted synthetic (e.g. baricitinib, tofacitinib) DMARD exposure for RA.
Contact & Investigator
Neil Basu, MD, PhD
PRINCIPAL INVESTIGATOR
University of Glasgow
Frequently Asked Questions
Who can join the NCT05697159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05697159 currently recruiting?
Yes, NCT05697159 is actively recruiting participants. Contact the research team at maxine.arnott@glasgow.ac.uk for enrollment information.
Where is the NCT05697159 trial being conducted?
This trial is being conducted at Glasgow, United Kingdom.
Who is sponsoring the NCT05697159 clinical trial?
NCT05697159 is sponsored by NHS Greater Glasgow and Clyde. The principal investigator is Neil Basu, MD, PhD at University of Glasgow. The trial plans to enroll 20 participants.
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