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

Phase 2TerminatedNCT03949673

Regeneron Pharmaceuticals23 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Osteoarthritis, Knee Osteoarthritis, Hip

Interventions

FasinumabDRUG

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

NaproxenDRUG

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

DiclofenacDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Regeneron Research Site

Phoenix, Arizona, United States

Regeneron Research Site

Littleton, Colorado, United States

Regeneron Research Site

Outcomes

Primary Outcomes

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).

Time frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months

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).

Time frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months

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).

Time frame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months

Data from ClinicalTrials.gov

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