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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03949673
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Regeneron Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trial Management
Principal Investigator Affiliation Regeneron Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries Poland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee, Osteoarthritis, Hip
Arms & Interventions

Arms

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

Interventions

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

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

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Regeneron Research Site, Birmingham, Alabama

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Regeneron Research Site

Birmingham, Alabama, 35211

Regeneron Research Site, Mesa, Arizona

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Regeneron Research Site

Mesa, Arizona, 85213

Regeneron Research Site, Phoenix, Arizona

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Regeneron Research Site

Phoenix, Arizona, 85018

Regeneron Research Site, Phoenix, Arizona

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Regeneron Research Site

Phoenix, Arizona, 85020

Regeneron Research Site, Phoenix, Arizona

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Regeneron Research Site

Phoenix, Arizona, 85225

Regeneron Recruiting Site, Tucson, Arizona

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Regeneron Recruiting Site

Tucson, Arizona, 85712

Regeneron Research Site, Anaheim, California

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Regeneron Research Site

Anaheim, California, 92805

Regeneron Research Site, Carlsbad, California

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Regeneron Research Site

Carlsbad, California, 92008

Regeneron Research Site #1, San Diego, California

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Regeneron Research Site #1

San Diego, California, 92103-6204

Regeneron Research Site, Littleton, Colorado

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Regeneron Research Site

Littleton, Colorado, 80127

Regeneron Research Site, Jacksonville, Florida

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Regeneron Research Site

Jacksonville, Florida, 32256

Regeneron Research Site, Ocoee, Florida

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Regeneron Research Site

Ocoee, Florida, 34761

Regeneron Research Site, Orlando, Florida

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Regeneron Research Site

Orlando, Florida, 32825

Regeneron Research Site, Plantation, Florida

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Regeneron Research Site

Plantation, Florida, 33324

Regeneron Research Site, Chicago, Illinois

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Regeneron Research Site

Chicago, Illinois, 60602

Regeneron Research Site, Chicago, Illinois

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Regeneron Research Site

Chicago, Illinois, 60611

Regeneron Research Site, Evansville, Indiana

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Regeneron Research Site

Evansville, Indiana, 47714

Regeneron Research Site, Marrero, Louisiana

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Regeneron Research Site

Marrero, Louisiana, 70072

Regeneron Research Site, Cumberland, Maryland

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Regeneron Research Site

Cumberland, Maryland, 21502

Regeneron Research Site, Hagerstown, Maryland

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Regeneron Research Site

Hagerstown, Maryland, 21740

Regeneron Research Site, Bay City, Michigan

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Regeneron Research Site

Bay City, Michigan, 48706

Regeneron Research Site, Saint Louis, Missouri

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Regeneron Research Site

Saint Louis, Missouri, 63141

Regeneron Research Site, Elkhorn, Nebraska

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Regeneron Research Site

Elkhorn, Nebraska, 68022

Regeneron Research Site, Lincoln, Nebraska

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Regeneron Research Site

Lincoln, Nebraska, 68516

Regeneron Research Site, Omaha, Nebraska

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Regeneron Research Site

Omaha, Nebraska, 68144

Regeneron Research Site, Henderson, Nevada

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Regeneron Research Site

Henderson, Nevada, 89052

Regeneron Research Site, Brooklyn, New York

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Regeneron Research Site

Brooklyn, New York, 11230

Regeneron Research Site, Hartsdale, New York

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Regeneron Research Site

Hartsdale, New York, 10530

Regeneron Research Site, New York, New York

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Regeneron Research Site

New York, New York, 10036

Regeneron Research Site, Dayton, Ohio

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Regeneron Research Site

Dayton, Ohio, 45432

Regeneron Research Site, Indiana, Pennsylvania

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Regeneron Research Site

Indiana, Pennsylvania, 15701

Regeneron Research Site, Indian Land, South Carolina

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Regeneron Research Site

Indian Land, South Carolina, 29707

Regeneron Research Site, Orangeburg, South Carolina

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Regeneron Research Site

Orangeburg, South Carolina, 29118

Regeneron Research Site, Plano, Texas

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Regeneron Research Site

Plano, Texas, 75093

Regeneron Research Site, Beckley, West Virginia

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Regeneron Research Site

Beckley, West Virginia, 25801

International Sites

Regeneron Research Site, Wroclaw, Dolnoslaskie, Poland

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Regeneron Research Site

Wroclaw, Dolnoslaskie, 50-088

Regeneron Research Site, Krakow, Malopolska, Poland

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Regeneron Research Site

Krakow, Malopolska, 31141

Regeneron Research Site, Krakow, Malopolskie, Poland

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Regeneron Research Site

Krakow, Malopolskie, 31-501

Regeneron Research Site, Warszawa, Mazowieckie, Poland

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Regeneron Research Site

Warszawa, Mazowieckie, 01-192

Regeneron Research Site, Gdansk, Pomorskie, Poland

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Regeneron Research Site

Gdansk, Pomorskie, 80-382

Regeneron Research Site, Poznan, Wielkopolskie, Poland

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Regeneron Research Site

Poznan, Wielkopolskie, 60-702

Regeneron Recruting SIte, Bialystok, Poland

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Address

Regeneron Recruting SIte

Bialystok, , 15-879

Regeneron Research Site, Gdynia, Poland

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Regeneron Research Site

Gdynia, , 81-537

Regeneron Research Site, Katowice, Poland

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Regeneron Research Site

Katowice, , 40-040

Regeneron Research Site, Katowice, Poland

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Regeneron Research Site

Katowice, , 40-648

Regeneron Recruting Site, Skierniewice, Poland

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Regeneron Recruting Site

Skierniewice, , 96-100

Regeneron Recruiting SIte, Zgierz, Poland

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Regeneron Recruiting SIte

Zgierz, , 95-100

Regeneron Research Site, Reading, Berkshire, United Kingdom

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Regeneron Research Site

Reading, Berkshire, RG2 0TG

Regeneron Research Site, Wokingham, Berkshire, United Kingdom

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Regeneron Research Site

Wokingham, Berkshire, RG40 1XS

Regeneron Research Site, Manchester, Greater Manchester, United Kingdom

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Regeneron Research Site

Manchester, Greater Manchester, M15 6SX

Regeneron Research Site, Sidcup, Kent, United Kingdom

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Regeneron Research Site

Sidcup, Kent, DA14 6LT

Regeneron Research Site, Glasgow, Lanarkshire, United Kingdom

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Regeneron Research Site

Glasgow, Lanarkshire, G20-0SP

Regeneron Research Site, Chorley, Lancashire, United Kingdom

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Regeneron Research Site

Chorley, Lancashire, PR7 7NA

Regeneron Research Site, Romford, London City, United Kingdom

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Regeneron Research Site

Romford, London City, RM1 3PJ

Regeneron Research Site, Northwood, Middlesex, United Kingdom

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Regeneron Research Site

Northwood, Middlesex, HA6 2RN

Regeneron Research Site, Corby, Northamptonshire, United Kingdom

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Regeneron Research Site

Corby, Northamptonshire, NN17 2UR

Regeneron Research Site, Hexham, Northumberland, United Kingdom

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Regeneron Research Site

Hexham, Northumberland, NE46 1QJ

Regeneron Research Site, Yaxley, Peterborough, United Kingdom

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Regeneron Research Site

Yaxley, Peterborough, PE7 3JL

Regeneron Recruiting Site, Hardwick, Stockton-on-Tees, United Kingdom

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Regeneron Recruiting Site

Hardwick, Stockton-on-Tees, TS19 8PE

Regeneron Research Site, Kenilworth, Warwickshire, United Kingdom

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Regeneron Research Site

Kenilworth, Warwickshire, CV8 1JD

Regeneron Research Site, Birmingham, West Midlands, United Kingdom

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Regeneron Research Site

Birmingham, West Midlands, B15 2SQ

Regeneron Research Site, Cardiff, United Kingdom

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Regeneron Research Site

Cardiff, , CF15 9SS

Regeneron Research Site, Liverpool, United Kingdom

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Regeneron Research Site

Liverpool, , L22 0LG

Regeneron Research Site, Shipley, United Kingdom

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Regeneron Research Site

Shipley, , BD18 3SA