Actively Recruiting

Age: 18Years - 74Years
All Genders
ID05697159

Exploiting Leading Edge 7 Tesla MRI Brain Imaging to Decipher Filgotinib's Mode of Analgesic Action in Rheumatoid Arthritis

Led by NHS Greater Glasgow and Clyde · Updated on 2025-01-14

20

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

N

NHS Greater Glasgow and Clyde

Lead Sponsor

L

Lakefront Biotherapeutics NV

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how the medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis (RA). This study focuses on understanding two main factors influencing pain relief: brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinib's impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.

CONDITIONS

Brief Title

7 Tesla MRI Brain Imaging to Decipher Filgotinib's Mode of Analgesic Action in Rheumatoid Arthritis

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years to less than 75 years
  • Diagnosis of moderate to severe active rheumatoid arthritis
  • Prescribed Filgotinib according to product guidelines
  • Right-handed to reduce brain imaging variability
Not Eligible

You will not qualify if you...

  • Unable to provide written informed consent
  • Severe physical impairments such as blindness, deafness, or paraplegia
  • Pregnant or breastfeeding
  • Severe claustrophobia preventing MRI
  • Contraindications to MRI scanning
  • Major neurological diseases including multiple sclerosis, stroke, or traumatic brain injury
  • Previous use of targeted synthetic DMARDs like baricitinib or tofacitinib for rheumatoid arthritis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 12 weeks

Participants undergo MRI brain imaging and assessments to evaluate the effects of Filgotinib on central nervous system pain sensitisation and peripheral inflammation related pain in rheumatoid arthritis.

Multiple visits including baseline and follow-up MRI and clinical assessments over 12 weeks

Trial Site Locations

Total: 1 location

1

Neil Basu

Glasgow, United Kingdom

Actively Recruiting

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Research Team

M

Maxine Arnott

N

Neil Basu, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Scoring ultrasound synovitis in rheumatoid arthritis: a EULAR-OMERACT ultrasound taskforce-Part 1: definition and development of a standardised, consensus-based scoring system.

Maria-Antonietta D'Agostino, Lene Terslev, Philippe Aegerter...

https://pubmed.ncbi.nlm.nih.gov/28948983