R475-OA-1688, Efficacy and Safety of Fasinumab
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID-Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip.
IRAS ID
238597
Contact name
Paul Ivan
Contact email
Sponsor organisation
Regeneron Pharmceuticals Inc
Eudract number
2017-001702-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Research Summary
This study designed to evaluate the efficacy and safety of fasinumab in patients with OA of the knee or hip who have a history of inadequate pain relief with acetaminophen/paracetamol and a history of intolerance to or inadequate pain relief with opioids.
There is an unmet need for alternative treatment options to the standard of care NSAIDs and opioids that have a more effective analgesic effect, particularly since a significant number of patients are intolerant to, or do not get adequate pain relief from, the currently available treatment options. Inadequate pain relief has a profound impact on the quality of life for millions of people worldwide.
The main aim of this study is to see how well the study drug Fasinumab compares to placebo when given to patients who have OA of the knee of hip. Toward this aim patients will be split into 3 separate active dosing arms and one placebo arm in the follow doses:
• 1mg subcutaneous (SC) injection every 4 weeks
• 3mg SC injection every 4 weeks
• 6mg SC injection every 8 weeks, with a placebo injection every 4 weeks
• Placebo SC injection every 4 weeks
There are also secondary aims to see how well Fasinumab compares to the two main standard of care NSAIDs. There are therefore 2 additional dosing arms of:
• Diclogenac 75mg by mouth twice daily (placebo injections)
• Cececoxib 200mg by mouth once daily (placebo injections)
All patients will receive injections at 4 weekly intervals and will take capsules twice daily with placebo injections and capsules used to maintain the blind.
The study is double blind, therefore neither the patient nor the study doctor will know who receives fasinumab, diclofenac, celecoxib, or placebo. The treatment period for this study is 24 weeks and there will be a follow up period of 20 weeks.Summary of Results
Background: Chronic musculoskeletal pain affects a large portion of the global population. A significant cause of chronic musculoskeletal pain is due to osteoarthritis (OA). Osteoarthritis is a progressive, chronic disease caused by the breakdown and loss of cartilage of the joints, which leads to pain in the hips, knees, hands, feet, or spine. There are a significant number of patients who are intolerant to, or do not get adequate pain relief from, the currently available treatment options for OA pain.
Purpose of the study: To determine whether treatment of patients with osteoarthritis of the knee or hip with fasinumab improves symptoms of pain and improves physical function as compared to placebo and compared to commonly prescribed non-steroidal anti-inflammatory drugs (NSAIDS; celecoxib and diclofenac).
To determine of treatment with fasinumab is well-tolerated by these patients.Study participants:This study included 1650 adult men and women with osteoarthritis of the knee or hip who had moderate to severe pain of osteoarthritis and had previously been treated with other available medications for pain.
Study design and research methodology:
• This was a multi-national study that enrolled patients at sites in North America, Europe and South Africa.
• The patients were randomly divided into a placebo group, an NSAID group, and a fasinumab group.
• Patients were followed for 24 weeks for improvement of pain and improvement of physical function.
• Side-effects were studied. X-rays and MRI’s were used to look for changes in joint structure.Key findings:
• Patients who were treated with fasinumab showed a larger improvement in pain at week 24 compared with the placebo group.
• Patients who were treated with fasinumab showed a larger improvement in physical function at week 24 compared with the placebo group.
• Patients who were treated with fasinumab showed a trend towards greater improvement in pain and physical functioning at week 24 compared with the NSAIDS group.
• There was no difference in the occurrence of joint replacements in any treatment group.
• A larger number of patients in the fasinumab group showed change in joint space width narrowing compared with both the placebo and NSAIDs groups.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0250
Date of REC Opinion
2 Jul 2018
REC opinion
Further Information Favourable Opinion