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

• Status: Terminated
• Trial end date: 2020-08-25
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Teva Pharmaceutical Industries, Ltd.
• Treatments: Celecoxib; Diclofenac; Fasinumab; Naproxen

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