NCT05697159Recruiting
7 Tesla MRI Brain Imaging to Decipher Filgotinib's Mode of Analgesic Action in Rheumatoid Arthritis
Exploiting Leading Edge 7 Tesla MRI Brain Imaging to Decipher Filgotinib's Mode of Analgesic Action in Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 15 Dec 2022
- Start date
- 22 Aug 2023
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05697159
What you commit to
- Study type: Observational
- Planned participants: 20
- From 22 Aug 2023 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous targeted synthetic (e.g. baricitinib, tofacitinib) DMARD exposure for RA.
Other illness
- Severe physical impairment (e.g. blindness, deafness, paraplegia).
- Major confounding neurological disease including MS, Stroke, Traumatic Brain Injury.
Other
- Inability to provide written informed consent.
- Pregnant or breast feeding.
- Severe claustrophobia precluding MRI.
- Contraindications to MRI.
Who the study is looking for
- 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).
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neil Basu Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.