Clinical trial NCT03949673: Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip
Official title: Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Teva Pharmaceutical Industries, Ltd.
First posted: 2019-05-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility 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

Primary outcomes:
measure: Number of Participants by Degree of Synovial Lymphocytic Inflammation
timeFrame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
measure: Number of Participants by Degree of Cartilage Loss
timeFrame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
measure: Number of Participants by Degree of Bony Changes
timeFrame: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Regeneron Research Site
state: Arizona
city: Littleton
country: United States
facility: Regeneron Research Site
state: Colorado
city: Jacksonville
country: United States
facility: Regeneron Research Site
state: Florida
city: Chicago
country: United States
facility: Regeneron Research Site
state: Illinois
city: Brooklyn
country: United States
facility: Regeneron Research Site
state: New York
city: New York
country: United States
facility: Regeneron Research Site
state: New York
city: Bialystok
country: Poland
facility: Regeneron Recruting SIte
city: Reading
country: United Kingdom
facility: Regeneron Research Site
state: Berkshire
city: Glasgow
country: United Kingdom
facility: Regeneron Research Site
state: Lanarkshire
city: Romford
country: United Kingdom
facility: Regeneron Research Site
state: London City
city: Northwood
country: United Kingdom
facility: Regeneron Research Site
state: Middlesex
city: Hexham
country: United Kingdom
facility: Regeneron Research Site
state: Northumberland
city: Yaxley
country: United Kingdom
facility: Regeneron Research Site
state: Peterborough
city: Kenilworth
country: United Kingdom
facility: Regeneron Research Site
state: Warwickshire
city: Liverpool
country: United Kingdom
facility: Regeneron Research Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: