KF7039-03_Phase III trial of RTX-GRT7039 in Osteoarthritis of the knee
Research type
Research Study
Full title
A single-arm, open-label, Phase III trial to evaluate the safety and tolerability of intra-articular injections of RTX-GRT7039 in subjects with moderate to severe pain associated with osteoarthritis of the knee.
IRAS ID
1005415
Contact name
Jessica Luppus
Contact email
Sponsor organisation
Grünenthal GmbH
Eudract number
2021-005046-15
Clinicaltrials.gov Identifier
Research summary
This is a phase 3, open-label (participants and Drs will know the treatment they are given/administering), single-arm (only 1 treatment will be given to participants) trial in participants who have moderate to severe pain associated with osteoarthritis of the knee. Potential participants should have ongoing knee pain despite receiving a continued treatment regimen or be unable to receive standard of care treatments due to contraindications or intolerability.
The trial has 2 stages, the 'screening period' (when tests will be performed to confirm trial eligibility) and the 'treatment and follow-up period'. Participants who continue to the treatment period will receive study treatment as an injection into their knee joint space in their 'index knee' (knee with the worst pain). Depending on, for example, their pain levels they may have another injection in the other knee a week later. Depending on subsequent assessments of knee pain participants may have repeated injections in one or both knees up to a maximum of 5 per knee.
The trial will last up to 82 weeks (approx. 1.5yrs). Around 930 participants will take part globally with 18 participants planned in the UK.
Study procedures will include: X-rays, MRI scans, blood and urine tests, ECGs, physical examinations and completion of questionnaires.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0112
Date of REC Opinion
14 Jun 2022
REC opinion
Further Information Favourable Opinion