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

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fasinumab
Naproxen
Diclofenac
Celecoxib
Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Recruting SIte
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site
  • Regeneron Research Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Knee or Hip Joint Arthroplasty

Arm Description

Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study

Outcomes

Primary Outcome Measures

Number of Participants by Degree of Synovial Lymphocytic Inflammation
Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band).
Number of Participants by Degree of Cartilage Loss
Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone).
Number of Participants by Degree of Bony Changes
Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis [Lamellar/Mixed], Subarticular Fracture/Collapse).

Secondary Outcome Measures

Full Information

First Posted
April 5, 2019
Last Updated
September 25, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Teva Pharmaceutical Industries, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03949673
Brief Title
Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip
Official Title
Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
August 25, 2020 (Actual)
Study Completion Date
August 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Teva Pharmaceutical Industries, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Hip

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knee or Hip Joint Arthroplasty
Arm Type
Other
Arm Description
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Intervention Type
Drug
Intervention Name(s)
Fasinumab
Other Intervention Name(s)
REGN475
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
ZORVOLEX
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
CELEBREX
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants by Degree of Synovial Lymphocytic Inflammation
Description
Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band).
Time Frame
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Title
Number of Participants by Degree of Cartilage Loss
Description
Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone).
Time Frame
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Title
Number of Participants by Degree of Bony Changes
Description
Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis [Lamellar/Mixed], Subarticular Fracture/Collapse).
Time Frame
Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Regeneron Research Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80127
Country
United States
Facility Name
Regeneron Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Regeneron Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Regeneron Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Facility Name
Regeneron Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Regeneron Recruting SIte
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Regeneron Research Site
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Regeneron Research Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G20-0SP
Country
United Kingdom
Facility Name
Regeneron Research Site
City
Romford
State/Province
London City
ZIP/Postal Code
RM1 3PJ
Country
United Kingdom
Facility Name
Regeneron Research Site
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Regeneron Research Site
City
Hexham
State/Province
Northumberland
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Regeneron Research Site
City
Yaxley
State/Province
Peterborough
ZIP/Postal Code
PE7 3JL
Country
United Kingdom
Facility Name
Regeneron Research Site
City
Kenilworth
State/Province
Warwickshire
ZIP/Postal Code
CV8 1JD
Country
United Kingdom
Facility Name
Regeneron Research Site
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/

Learn more about this trial

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

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