R475-OA-1815 Study to Evaluate Synovial Fluid
Research type
Research Study
Full title
Study to Evaluate Synovial Fluid in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
IRAS ID
253456
Contact name
Nicholas Probert
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2018-001411-71
Clinicaltrials.gov Identifier
103245, IND Number
Duration of Study in the UK
0 years, 10 months, 19 days
Research summary
This study is a non-randomised, exploratory study within the fasinumab phase 3 program that will enrol osteoarthritis (OA) patients with an index knee joint (i.e joint affected by OA and selected for primary assessment) who are participating in an ongoing fasinumab phase 3 parent study.
This study will be conducted at a subset of sites operationalising the parent studies.
Patients will follow the screening, pre-randomisation, treatment, and follow-up requirements for their parent study.
If a patient is eligible for and consents to this study, the patient will undergo an ultrasound guided aspiration (collecting synovial fluid from a joint capsule using a syringe) of the index knee joint after MRI results indicating the presence of an effusion (swelling) are received.
The first ultrasound guided aspiration will take place on day 1 of the parent study. After the 16-week visit in the parent study, a second (and final) ultrasound guided aspiration of the index knee joint will be performed. The total duration of this study will be approximately 113 days for each patient.
The synovial fluid collected on day 1 and at week 16 will be compared to measure biomarkers related to the effects of fasinumab, target biology, inflammation, bone metabolism, and pain.
The information collected from the biomarker analysis of these samples will be used to better understand the side effects that may be experienced by people taking fasinumab and how fasinumab works in the body.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0315
Date of REC Opinion
3 Dec 2018
REC opinion
Further Information Favourable Opinion