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

Phase 2

Terminated

• Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee
• Interventions: Drug: Fasinumab; Drug: Naproxen; Drug: Diclofenac; Drug: Celecoxib; Drug: Placebo

• Registration Number: NCT03949673
• Lead Sponsor: Regeneron Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-05
• Study Start: 2019-04-08
• Study First Submitted QC: 2019-05-11
• Study First Posted: 2019-05-14
• Primary Completion: 2020-08-25
• Study Completion: 2020-08-25
• Disposition First Submitted: 2021-08-24
• Results First Submitted: 2023-08-15
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Results First Posted: 2023-10-17
• Disposition First Posted: 2023-10-17
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Knee or Hip Joint Arthroplasty	Celecoxib	Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Knee or Hip Joint Arthroplasty	Placebo	Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Knee or Hip Joint Arthroplasty	Fasinumab	Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Knee or Hip Joint Arthroplasty	Naproxen	Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study
Knee or Hip Joint Arthroplasty	Diclofenac	Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study

Primary Outcome Measures

Name	Time	Method
Number of Participants by Degree of Cartilage Loss	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	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	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).

Trial Locations

Locations (2)

Regeneron Recruting SIte; 🇵🇱 Bialystok, Poland

Regeneron Research Site; 🇬🇧 Liverpool, United Kingdom