R475-OA-1816 Study to Evaluate Arthroplasty Specimens

• Research type

  Research Study

• Full title

  Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip

• IRAS ID

  253454

• Contact name

  Nicholas Probert

• Contact email

  nick.probert@synexus.com

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Eudract number

  2018-001618-13

• Clinicaltrials.gov Identifier

  103245, IND Number

• Duration of Study in the UK

  2 years, 1 months, 23 days

• Research summary

  Research Summary
  This study involves research examining the biological structure of joints in people who are enrolled in the fasinumab program. Patients in this study will have taken either fasinumab or placebo (an inactive substance) or are taking medications like naproxen, diclofenac, or celecoxib (non-steroidal anti-inflammatory drugs [NSAIDs]).
  This will be done by looking at samples of bone, cartilage, and synovium (tissue inside the joint) under the microscope. These samples will come from the tissue that is normally removed when someone has a joint replacement.
  In this study, samples of the patients joint tissue will be collected during their scheduled Joint Replacement surgery.
  Joint related adverse events (arthralgia, joint swelling, and peripheral edema) are identified risks in the fasinumab program. It is thought that evaluation of tissue from arthroplasty specimens may provide insight into the mechanisms of these events.
  Patients will consent to this study after notifying their parent study doctor that they are planning a knee or hip joint arthroplasty. The study will be conducted at sites where the parent studies are active. Patients will then enter a variable time until joint arthroplasty while they are enrolled in the parent study. Their participation will end on the day they undergo joint arthroplasty.

  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 and knees, sometimes this leads to joint replacement. 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 such as non-steroidal anti-inflammatory drugs. Fasinuimab is being studied to determine if symptoms of osteoarthritis pain and physical function can be improved. Joint-related adverse events have been observed with fasinumab therapy.

  Purpose of the study: To determine whether examination of the tissues that are routinely removed when a patient has joint replacement surgery can provided insight into the mechanism of joint related adverse events.

  Study participants: This study included 20 adult men and women with osteoarthritis of the knee or hip who also participated in one of three phase three parent studies of fasinumab and had a joint replacement

  Study design and research methodology:
  • This was a multi-national study that enrolled patients at sites in North America and Europe.
  • In the parent studies, patients were randomly divided into a placebo group, an NSAID group, and a fasinumab group.
  • Joint tissue that is routinely removed during joint replacement surgery was collected and analyzed under a microscope by experts in joint pathology

  Key findings:
  • There was a small number of patients in each group, making comparisons difficult
  • Consistent to what has been described in the scientific literature for osteoarthritis, when the lining of the joint was examined under the microscope, all treatment groups showed some degree of inflammation with slightly more seen in the fasinumab arm.
  • When bone was observed under the microscope, a similar percentage of patients in the NSAIDS arm and the fasinumab arm showed the presence of compression fracture.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  18/EM/0316

• Date of REC Opinion

  28 Nov 2018

• REC opinion

  Further Information Favourable Opinion