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
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

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