R475-OA-1611 Patients with Pain Due to Osteoarthritis of the Knee/Hip

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Pain Due to Osteoarthritis of the Knee or Hip.

• IRAS ID

  226962

• Contact name

  Paul Ivan

• Contact email

  pivan@medinovaresearch.com

• Sponsor organisation

  Regeneron Pharmaceuticals Inc.,

• Eudract number

  2016-005020-29

• Duration of Study in the UK

  3 years, 0 months, 1 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 (OA) of the knee or hip.

  This study will include approximately 3640 patients at approximately 150 centres globally.

  The patient will be assigned by chance (randomised) to receive fasinumab or placebo (an inactive drug) or Naproxen (a standard-of-care non steroid anti inflammatory drugs (NSAID) for moderate-to-severe pain due to OA) in one of the following 5 arms (or treatment groups):
  1. Fasinumab 1 mg every 4 weeks and naproxen placebo twice daily
  2. Fasinumab 3 mg every 4 weeks and naproxen placebo twice daily
  3. Fasinumab 6 mg every 8 weeks and naproxen placebo twice daily (injections will be given every 4 weeks during study visits; active facinumab will be given on alternating 4-week visits with placebo fasinumab)
  4. Naproxen 500 mg orally, twice daily and fasinumab placebo every 4 weeks
  5. Fasinumab placebo every 4 weeks and naproxen placebo twice daily

  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 and Naproxen-Controlled Study to Evaluate the Efficacy and Safety 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 OA of the knee or hip with fasinumab improves symptoms of pain and improves physical function as compared with placebo and compared to a commonly prescribed non-steroidal anti-inflammatory drug (NSAID; naproxen).
  To determine if treatment with fasinumab is well-tolerated by these patients.

  Study participants: This study included 3307 adult men and women with OA 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, a naproxen group, and groups treated with different doses of fasinumab.
  • Patients were followed for improvement of pain due to OA 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 the fasinumab 1 mg every four weeks dose showed a larger improvement in pain at week 16 compared with the placebo group.
  • Patients who were treated with fasinumab 1 mg every four weeks dose showed a larger improvement in physical function at week 16 compared with the placebo group.
  • Patients who were treated with fasinumab 1 mg every four weeks dose showed a trend towards greater improvement in pain and physical functioning at week 16 compared with the those treated with naproxen.
  • A larger number of patients in the fasinumab groups underwent joint replacement compared with both the placebo and naproxen groups.
  • A larger number of patients in the fasinumab groups showed rapid worsening of osteoarthritis compared with both the placebo and naproxen groups.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  17/NW/0430

• Date of REC Opinion

  14 Nov 2017

• REC opinion

  Further Information Favourable Opinion