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

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee

Treatments: Drug: Fasinumab; Drug: Diclofenac; Drug: Placebo; Drug: Celecoxib; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03949673

2018-001618-13 (EudraCT Number)

R475-OA-1816

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Knee or Hip Joint Arthroplasty

Other group

Description:

Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study

Treatment:

Drug: Celecoxib

Drug: Diclofenac

Drug: Naproxen

Drug: Placebo

Drug: Fasinumab