R475-PN-1523 Fasinumab in patients with knee or hip osteoarthritis
Research type
Research Study
Full title
A phase 3 randomised, double-blind, multi-dose, placebo-controlled study to evaluate the long-term safety and the efficacy of Fasinumab in patients with pain due to osteoarthritis of the knee or hip
IRAS ID
200701
Contact name
Nicholas Probert
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2015-003783-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 14 days
Research summary
Research Summary
This is a phase 3 study to assess the long term safety and the efficacy of Fasinumab in patients with pain due to osteoarthritis of the knee or hip.
Approximately 10,000 participants (men and women) will take part in this study in about 200 centres around the world. Suitable participants will be randomised (chosen by chance) into three treatment groups (Fasinumab dose 1, Fasinumab dose 2 or placebo [an inactive substance that looks like the study drug but has no medicine in it]).
During study visits the following study procedures may be performed: blood tests, urine tests, x-rays, electrocardiograms and several other clinical examinations. In addition, participants will complete a series of questionnaires and keep a daily diary.Summary of Results
A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients with Pain Due to Osteoarthritis of the Knee or Hip
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 (dummy treatment).
To determine of treatment with fasinumab is well-tolerated by these patients.
Study participants: This study included 5331 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, Latin America, Europe, and Asia Pacific/South Africa.
• The patients were randomly divided into a placebo group and a fasinumab treatment groups at various dose levels.
• The study consisted of a screening period of up to 30 days (Screening Period), followed by a 7- to 10-day pre randomization period (Pre-Randomization Period), a 52 week treatment period comprised of a 16 week randomized, double blind, placebo-controlled treatment period (Treatment Period 1), and a 36 week, double-blind, placebo controlled treatment period (Treatment Period 2), a 20 week follow up period following the end of treatment period 2 (Follow-Up Period), and an end of study (EOS) phone contact at 52 weeks following the last dose of study drug (EOS Phone Contact).
• 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 for the duration of treatment compared with the placebo group.
• Patients who were treated with fasinumab showed a larger improvement in physical function for the duration of treatment compared with the placebo group.
• Adjudicated arthropathy and joint replacement surgery were seen in all treatment groups; however, a dose-dependent risk was observed across the fasinumab treatment arms
• Across all treatment groups, the majority of patients with on-study adverse events experienced events that were mild or moderate in severity.
• No neutralizing antibodies against fasinumab were detected following fasinumab treatment.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0228
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion