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NCT03949673 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03949673
Other study ID # R475-OA-1816
Secondary ID 2018-001618-13
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 8, 2019
Est. completion date August 25, 2020

Study information
Verified date September 2023
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 23
Est. completion date August 25, 2020
Est. primary completion date August 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• 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
• 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
• 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
• 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

Locations
Country Name City State
Poland Regeneron Recruting SIte Bialystok
United Kingdom Regeneron Research Site Glasgow Lanarkshire
United Kingdom Regeneron Research Site Hexham Northumberland
United Kingdom Regeneron Research Site Kenilworth Warwickshire
United Kingdom Regeneron Research Site Liverpool
United Kingdom Regeneron Research Site Northwood Middlesex
United Kingdom Regeneron Research Site Reading Berkshire
United Kingdom Regeneron Research Site Romford London City
United Kingdom Regeneron Research Site Yaxley Peterborough
United States Regeneron Research Site Brooklyn New York
United States Regeneron Research Site Chicago Illinois
United States Regeneron Research Site Jacksonville Florida
United States Regeneron Research Site Littleton Colorado
United States Regeneron Research Site New York New York
United States Regeneron Research Site Phoenix Arizona

Sponsors (2)
Lead Sponsor Collaborator
Regeneron Pharmaceuticals Teva Pharmaceutical Industries, Ltd.

Countries where clinical trial is conducted

United States,  Poland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Primary 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). Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Primary 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). Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
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