Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip

September 25, 2023 updated by: Regeneron Pharmaceuticals

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

The objective of this exploratory study is to evaluate the cellular and connective tissue composition of joints from patients with Osteoarthritis (OA) who have been treated with fasinumab, compared with those treated with placebo or Non-steroidal anti-inflammatory drugs (NSAIDs).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland, 15-879
        • Regeneron Recruting SIte
  • United Kingdom
      • Liverpool, United Kingdom, L22 0LG
        • Regeneron Research Site
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG2 0TG
        • Regeneron Research Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G20-0SP
        • Regeneron Research Site
    • London City
      • Romford, London City, United Kingdom, RM1 3PJ
        • Regeneron Research Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Regeneron Research Site
    • Northumberland
      • Hexham, Northumberland, United Kingdom, NE46 1QJ
        • Regeneron Research Site
    • Peterborough
      • Yaxley, Peterborough, United Kingdom, PE7 3JL
        • Regeneron Research Site
    • Warwickshire
      • Kenilworth, Warwickshire, United Kingdom, CV8 1JD
        • Regeneron Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Regeneron Research Site
    • Colorado
      • Littleton, Colorado, United States, 80127
        • Regeneron Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Regeneron Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Regeneron Research Site
    • New York
      • Brooklyn, New York, United States, 11230
        • Regeneron Research Site
      • New York, New York, United States, 10036
        • Regeneron Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Previously randomized to R475-PN-1523 (NCT02683239), R475-OA-1611 (NCT03161093), or R475-OA-1688 (NCT03304379) and received at least 1 dose of study drug
  • Notified the site that they are planning a knee or hip arthroplasty during the parent study between randomization and 24 weeks after the last dose of subcutaneous (SC) study drug
  • Patient's surgeon/pathologist is willing to coordinate with the site regarding preparation, storage, and shipping of joint tissue samples collected during arthroplasty surgery

Exclusion Criteria:

  • None

Note: Other protocol Inclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Drug: Fasinumab
Study drug will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
Other Names:
  • REGN475
Drug: Naproxen
Naproxen will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
Drug: Diclofenac
Diclofenac will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
Other Names:
  • ZORVOLEX
Drug: Celecoxib
Celecoxib will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
Other Names:
  • CELEBREX
Drug: Placebo
Matching Placebo will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants by Degree of Synovial Lymphocytic Inflammation
Time Frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band).
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Number of Participants by Degree of Cartilage Loss
Time Frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone).
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Number of Participants by Degree of Bony Changes
Time Frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis [Lamellar/Mixed], Subarticular Fracture/Collapse).
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Teva Pharmaceutical Industries, Ltd.

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Actual)

August 25, 2020

Study Completion (Actual)

August 25, 2020

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

May 11, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R475-OA-1816
  • 2018-001618-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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