Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
Overview
- Phase
- Phase 2
- Intervention
- Fasinumab
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Number of Participants by Degree of Cartilage Loss
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
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
- •Note: Other protocol Inclusion criteria apply
Arms & Interventions
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Intervention: Fasinumab
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Intervention: Naproxen
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Intervention: Diclofenac
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Intervention: Celecoxib
Knee or Hip Joint Arthroplasty
Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Intervention: Placebo
Outcomes
Primary Outcomes
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).
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).
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).