Study of FX006 Effect on Synovial Inflammation in OA Knee Patients
Research type
Research Study
Full title
An Open-Label Study to Evaluate the Effect of the Administration of FX006 on Synovial Inflammation in Patients with Osteoarthritis of the Knee
IRAS ID
247072
Contact name
Philip Conaghan
Contact email
Sponsor organisation
Flexion Therapeutics Inc
Eudract number
2018-000529-30
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1214-3078, The Universal Trial Number (UTN)
Duration of Study in the UK
0 years, 7 months, 10 days
Research summary
This study is sponsored by Flexion Therapeutics, Inc and will be conducted in the United States and UK.
Osteoarthritis is a type of joint disease caused by the breakdown of joint cartilage and underlying bone, causing joint pain, tenderness, swelling, stiffness and limited movement. Synovial fluid is a thick jelly-like liquid that helps to cushion the knee and acts to absorb the impact of walking, running and stair climbing. The synovial membrane lines the joint capsule and helps maintain synovial fluid in joints. Although osteoarthritis is considered a non-inflammatory condition, it is widely accepted that synovial inflammation is a feature of osteoarthritis. Osteoarthritis cannot be cured but can be helped by medications, therapies, and procedures such as injections, osteotomy or joint replacement.
FX006 is an extended-release formulation of triamcinolone acetonide (TA) for IA administration. It is approved in the US under the trade name ZILRETTA (triamcinolone
acetonide extended-release injectable suspension) for the management of pain of osteoarthritis of
the knee.The study design is an open- label trial and all subjects will receive a triamcinolone acetonide. Approximately 100 subjects will be enrolled and treated with a single knee joint injection (intra-articular) although the number of subjects may be increased during the course of the trial to a maximum of 160.
One NHS hospital with specialist facilities (and 9 US sites) will take part in the study.
The study will consist of three periods, for a total study period of approximately 28 weeks.
•Screening period: Up to 28 days.
•Treatment period: One day.
•Follow-up period: 24 weeks.
The purpose of this study is to evaluate the effectiveness of a single intra-articular injection of triamcinolone acetonide in controlling inflammation, measured by a reduction in Magnetic Resonance Imaging assessed synovial volume in patients with osteoarthritis of the knee.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0569
Date of REC Opinion
6 Nov 2018
REC opinion
Unfavourable Opinion