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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT03949673

Collaborator

Teva Pharmaceutical Industries, Ltd. (Industry)

Enrollment

Locations

Arm

16.6

Actual Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Osteoarthritis, Hip	Drug: Fasinumab Drug: Naproxen Drug: Diclofenac Drug: Celecoxib Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip

Actual Study Start Date :

Apr 8, 2019

Actual Primary Completion Date :

Aug 25, 2020

Actual Study Completion Date :

Aug 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Knee or Hip Joint Arthroplasty Patients with OA of the knee or hip who are participating in an ongoing fasinumab phase 3 parent study	Drug: Fasinumab 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 Other Names: REGN475 Drug: Naproxen 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 Drug: Diclofenac 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 Other Names: ZORVOLEX Drug: Celecoxib Celecoxib 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 Other Names: CELEBREX Drug: Placebo Matching Placebo 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

Arm

Intervention/Treatment

Other: Knee or Hip Joint Arthroplasty

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

Drug: Fasinumab

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

Other Names:

REGN475

Drug: Naproxen

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

Drug: Diclofenac

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

Other Names:

ZORVOLEX

Drug: Celecoxib

Celecoxib 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

Other Names:

CELEBREX

Drug: Placebo

Matching Placebo 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

Outcome Measures

Primary Outcome Measures

Number of patients with histological findings not characteristic of advanced osteoarthritis [From time of randomization into parent study until 24 weeks following last dose of study drug]
Hematoxylin and eosin staining of joint tissue

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regeneron Research Site	Phoenix	Arizona	United States	85020
2	Regeneron Research Site	Littleton	Colorado	United States	80127
3	Regeneron Research Site	Jacksonville	Florida	United States	32256
4	Regeneron Research Site	Chicago	Illinois	United States	60611
5	Regeneron Research Site	Brooklyn	New York	United States	11230
6	Regeneron Research Site	New York	New York	United States	10036
7	Regeneron Recruting SIte	Bialystok		Poland	15-879
8	Regeneron Research Site	Reading	Berkshire	United Kingdom	RG2 0TG
9	Regeneron Research Site	Glasgow	Lanarkshire	United Kingdom	G20-0SP
10	Regeneron Research Site	Romford	London City	United Kingdom	RM1 3PJ
11	Regeneron Research Site	Northwood	Middlesex	United Kingdom	HA6 2RN
12	Regeneron Research Site	Hexham	Northumberland	United Kingdom	NE46 1QJ
13	Regeneron Research Site	Yaxley	Peterborough	United Kingdom	PE7 3JL
14	Regeneron Research Site	Kenilworth	Warwickshire	United Kingdom	CV8 1JD
15	Regeneron Research Site	Liverpool		United Kingdom	L22 0LG