Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip (FACT LTS & OA)

October 11, 2023 updated by: Regeneron Pharmaceuticals

A Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5331

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Regeneron Investigational Site
      • Plovdiv, Bulgaria, 4000
        • Regeneron Investigational Site #1
      • Plovdiv, Bulgaria, 4002
        • Regeneron Investigational Site #2
      • Plovdiv, Bulgaria, 4004
        • Regeneron Investigational Site #3
      • Sofia, Bulgaria, 1000
        • Regeneron Investigational Site #1
      • Sofia, Bulgaria, 1612
        • Regeneron Investigational Site #2
      • Stara Zagora, Bulgaria, 6000
        • Regeneron Investigational Site
  • Chile
      • Santiago, Chile, 8331143
        • Regeneron Investigational Site
  • Colombia
      • Bogota, Colombia, 110221
        • Regeneron Investigational Site
      • Medellin, Colombia, 50003
        • Regeneron Investigational Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Regeneron Investigational Site
      • Ballerup, Denmark, 2750
        • Regeneron Investigational Site
      • Vejle, Denmark, DK 7100
        • Regeneron Investigational Site
  • Estonia
      • Paide, Estonia, 72713
        • Regeneron Investigational Site
      • Tallinn, Estonia, 10128
        • Regeneron Investigational Site
  • Germany
      • Berlin, Germany, 1267
        • Regeneron Investigational Site
      • Bochum, Germany, 44787
        • Regeneron Investigational Sites
      • Frankfurt, Germany, 60313
        • Regeneron Investigational Site
      • Magdeburg, Germany, 39120
        • Regeneron Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Regeneron Investigational Site
  • Hong Kong
      • Central, Hong Kong
        • Regeneron Investigational Site
  • Hungary
      • Budapest, Hungary, 1036
        • Regeneron Investigational Site
      • Debrecen, Hungary, 4025
        • Regeneron Investigational Site
      • Gyula, Hungary, 5700
        • Regeneron Investigational Site
      • Hatvan, Hungary, 3000
        • Regeneron Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • Regeneron Investigational Site
  • Italy
      • Firenze, Italy, 50139
        • Regeneron Investigational Site
      • Naples, Italy, 80138
        • Regeneron Investigational Site
  • Lithuania
      • Alytus, Lithuania, LT-62114
        • Regeneron Investigational Site
      • Kaunas, Lithuania, 48259
        • Regeneron Investigational Site
      • Vilnius, Lithuania, 10323
        • Regeneron Investigational Site
      • Šiauliai, Lithuania, LT-76231
        • Regeneron Investigational Site
  • Mexico
    • Baja Californina
      • Mexicali, Baja Californina, Mexico, 21100
        • Regeneron Investigational Site
    • Ciudad De Mexico
      • Cuauhtemoc, Ciudad De Mexico, Mexico, 06700
        • Regeneron Investigational Site
      • Cuauhtémoc, Ciudad De Mexico, Mexico, 06700
        • Regeneron Investigational Site
    • DF
      • Distrito Federal, DF, Mexico, 03100
        • Regeneron Investigational Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 11850
        • Regeneron Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Regeneron Investigational Site
      • Guadalajara, Jalisco, Mexico, 44660
        • Regeneron Investigational Site
    • Mexico City
      • Cuauhtemoc, Mexico City, Mexico, 06100
        • Regeneron Investigational Site
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • Regeneron Investigational Site
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80000
        • Regeneron Investigational Site
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Regeneron Investigational Site
      • Merida, Yucatan, Mexico, C.P. 97070
        • Regeneron Investigational Site
  • Peru
      • Lima, Peru, 27
        • Regeneron Investigational Site
  • Poland
      • Gdańsk, Poland, 80-382
        • Regeneron Investigational Site
      • Gdynia, Poland, 81-537
        • Regeneron Investigational Site
      • Katowice, Poland, 40-040
        • Regeneron Investigational Site
      • Kraków, Poland, 31-501
        • Regeneron Investigational Site
      • Poznań, Poland, 60-702
        • Regeneron Investigational Site
      • Warszawa, Poland, 01-192
        • Regeneron Investigational Site #1
      • Warszawa, Poland, 01-192
        • Regeneron Investigational Site #2
      • Wrocław, Poland, 50-381
        • Regeneron Investigational Site
      • Łódź, Poland, 90-368
        • Regeneron Investigational Site
  • Romania
      • Bucharest, Romania, 021611
        • Regeneron Investigational Site #2
      • Bucharest, Romania, 30463
        • Regeneron Investigational Site #1
  • Russian Federation
      • Kazan', Russian Federation, 420012
        • Regeneron Investigational Site
      • Novosibirsk, Russian Federation, 630091
        • Regeneron Investigational Site
      • Samara, Russian Federation, 443095
        • Regeneron Investigational Site
      • Tomsk, Russian Federation, 634050
        • Regeneron Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • Regeneron Investigational Site #2
      • Yaroslavl, Russian Federation, 150007
        • Regeneron Investigational Site #1
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Regeneron Investigational Site
      • Cape Town, South Africa, 7530
        • Regeneron Investigational Site
      • Kempton Park, South Africa, 1619
        • Regeneron Investigational Site
      • Parow, South Africa, 7500
        • Regeneron Investigational Site
      • Port Elizabeth, South Africa, 6001
        • Regeneron Investigational Site
      • Pretoria, South Africa, 0122
        • Regeneron Investigational Site
      • Roodepoort, South Africa, 1724
        • Regeneron Investigational Site
      • Somerset West, South Africa, 7130
        • Regeneron Investigational Site
      • Soweto, South Africa, 1818
        • Regeneron Investigational Site
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0184
        • Regeneron Investigational Site #1
      • Pretoria, Gauteng, South Africa, 0184
        • Regeneron Investigational Site #2
  • Spain
      • A Coruna, Spain, 15006
        • Regeneron Investigational Site
      • Barcelona, Spain, 08025
        • Regeneron Investigational Site
      • Madrid, Spain, 28100
        • Regeneron Investigational Site
      • Sevilla, Spain, 41010
        • Regeneron Investigational Site
  • Sweden
      • Boras, Sweden, 50630
        • Regeneron Investigational Site
      • Goteburg, Sweden, 413 45
        • Regeneron Investigational Site
      • Helsingborg, Sweden, 25220
        • Regeneron Investigational Site
      • Linkoping, Sweden, 587 58
        • Regeneron Investigational Site
      • Lund, Sweden, 222 22
        • Regeneron Investigational Site
      • Uppsala, Sweden, 75237
        • Regeneron Investigational Site
      • Vällingby, Sweden, 16268
        • Regeneron Investigational Site
    • Skane
      • Malmo, Skane, Sweden, 211 52
        • Regeneron Investigational Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Regeneron Investigational Site
      • Kyiv, Ukraine, 02002
        • Regeneron Investigational Site #3
      • Kyiv, Ukraine, 03037
        • Regeneron Investigational Site #1
      • Kyiv, Ukraine, 03049
        • Regeneron Investigational Site #2
      • Lviv, Ukraine, 79495
        • Regeneron Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SQ
        • Regeneron Investigational Site
      • Chorley, United Kingdom, PR7 7NA
        • Regeneron Investigational Site
      • Glasgow, United Kingdom, G20 0SP
        • Regeneron Investigational Site
      • Hexham, United Kingdom, NE46 1QJ
        • Regeneron Investigational Site
      • Liverpool, United Kingdom, L22 0LG
        • Regeneron Investigational Site
      • Manchester, United Kingdom, M15 6SE
        • Regeneron Investigational Site
      • Middlesex, United Kingdom, HA6 2RN
        • Regeneron Investigational Site
      • Reading, United Kingdom, RG2 0TG
        • Regeneron Investigational Site
      • Romford, United Kingdom, RM1 3PJ
        • Regeneron Investigational Site
      • Sidcup, United Kingdom, DA14 6LT
        • Regeneron Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Regeneron Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Regeneron Investigational Site #1
      • Chandler, Arizona, United States, 85224
        • Regeneron Investigational Site #2
      • Glendale, Arizona, United States, 85308
        • Regeneron Investigational Site
      • Mesa, Arizona, United States, 85213
        • Regeneron Investigational Site
      • Phoenix, Arizona, United States, 85018
        • Regeneron Investigational Site (4 locations)
      • Tempe, Arizona, United States, 85224
        • Regeneron Investigational Site
      • Tucson, Arizona, United States, 85712
        • Regeneron Investigational Site (2 locations)
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Regeneron Investigational Site
    • California
      • Beverly Hills, California, United States, 90211
        • Regeneron Investigational Site
      • Carlsbad, California, United States, 92008
        • Regeneron Investigational Site
      • San Diego, California, United States, 92103
        • Regeneron Investigational Site
      • San Marcos, California, United States, 92078
        • Regeneron Investigational Site
      • Vista, California, United States, 92083
        • Regeneron Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Regeneron Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • Regeneron Investigational Site
      • Golden, Colorado, United States, 80401
        • Regeneron Investigational Site
      • Littleton, Colorado, United States, 80127
        • Regeneron Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Regeneron Investigational Site
      • Orlando, Florida, United States, 32801
        • Regeneron Investigational Site
      • Pinellas Park, Florida, United States, 33781
        • Regeneron Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Regeneron Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Regeneron Investigational Site (3 locations)
      • Evansville, Illinois, United States, 47714
        • Regeneron Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 64114
        • Regeneron Investigational Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Regeneron Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Regeneron Investigational Site
    • Minnesota
      • Richfield, Minnesota, United States, 55423
        • Regeneron Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Regeneron Investigational Site #1
      • Saint Louis, Missouri, United States, 63141
        • Regeneron Investigational Site #2
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Regeneron Investigational Site
      • Fremont, Nebraska, United States, 68025
        • Regeneron Investigational Site
      • Omaha, Nebraska, United States, 68144
        • Regeneron Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Regeneron Investigational Site
    • New York
      • Jamaica, New York, United States, 11432
        • Regeneron Investigational Site
      • New York, New York, United States, 10036
        • Regeneron Investigational Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Regeneron Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Regeneron Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Regeneron Investigational Site
      • Columbus, Ohio, United States, 43212
        • Regeneron Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73119
        • Regeneron Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Regeneron Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Regeneron Investigational Site
      • Greer, South Carolina, United States, 29651
        • Regeneron Investigational Site
    • Texas
      • Dallas, Texas, United States, 75234
        • Regeneron Investigational Site #1
      • Dallas, Texas, United States, 75234
        • Regeneron Investigational Site #2
      • Houston, Texas, United States, 77008
        • Regeneron Investigational Site
      • Lubbock, Texas, United States, 79424
        • Regeneron Investigational Site
      • Plano, Texas, United States, 75093
        • Regeneron Investigational Site
      • San Antonio, Texas, United States, 78229
        • Regeneron Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Male or female ≥18 years of age at the screening visit
  2. Clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2) for the index joint at the screening visit
  3. Moderate to severe pain in the index joint defined as a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) average pain subscale score of ≥4
  4. A history of 12 weeks of analgesic use for OA of the knee or hip
  5. History of regular use of analgesic medications for OA pain

Key Exclusion Criteria:

  1. History or presence at the screening visit of non OA inflammatory joint disease
  2. History or presence on imaging of arthropathy, stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas or pathologic fracture during the screening period
  3. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
  4. Patient is not a candidate for MRI
  5. Is scheduled for a joint replacement surgery to be performed during the study period
  6. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit.
  7. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
  8. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
  9. Pregnant or breast-feeding women
  10. Women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline

Note: Other protocol defined Inclusion/Exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Placebo
Drug: Placebo
Participants will receive sub-cutaneous (SC) injections of matching placebo
Experimental: Fasinumab dosing regimen 1
Drug: Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Other Names:
  • REGN475
Experimental: Fasinumab dosing regimen 2
Drug: Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Other Names:
  • REGN475

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)
Time Frame: Baseline up to week 52
Baseline up to week 52
Number of Participants With Any Serious TEAE
Time Frame: Baseline up to week 52
Baseline up to week 52
Number of Participants With Any Adverse Event (AE) up to Week 72
Time Frame: Baseline up to week 72
Baseline up to week 72
Number of Participants With Any Serious AE up to Week 72
Time Frame: Baseline up to week 72
Baseline up to week 72
Number of Participants With Adjudicated Arthropathy (AA)
Time Frame: Baseline up to week 52 and week 72
Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
Baseline up to week 52 and week 72
Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria
Time Frame: Baseline up to week 52 and week 72
DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.
Baseline up to week 52 and week 72
Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation
Time Frame: Baseline up to week 72
Any participant with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an adverse event of special interest (AESI).
Baseline up to week 72
Number of Participants With Sympathetic Nervous System (SNS) Dysfunction
Time Frame: Baseline up to week 72
Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.
Baseline up to week 72
Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery
Time Frame: Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)
All joint replacement surgery events regardless of cause at weeks 52 and 72. An end of study phone contact was also conducted approximately 52 weeks following the last dose of study drug.
Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52
Time Frame: Baseline to week 52
Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the treatment period were reported. Clinical significance was determined by the investigator.
Baseline to week 52
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72
Time Frame: End of treatment up to week 72
Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the post-treatment period were reported. Clinical significance was determined by the investigator.
End of treatment up to week 72
Number of Participants With Anti-drug Antibody (ADA) up to Week 72
Time Frame: Baseline up to week 72
Immunogenicity was characterized by ADA responses & titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses less than (<) 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, greater than or equal to (≥) 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the fasinumab ADA assay post first dose when baseline results = negative or missing.
Baseline up to week 72
Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis
Time Frame: Baseline to Week 16
The PGA of OA is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 16
Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score
Time Frame: Baseline to Week 16
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. Participants who achieved a response, where response was defined as an improvement by ≥30% in WOMAC pain subscale score
Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Teva Pharmaceutical Industries, Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R475-PN-1523
  • 2015-003783-36 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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