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

Primary Purpose

Osteoarthritis of the Knee or Hip

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fasinumab

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee or Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Male or female ≥18 years of age at the screening visit
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
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
A history of 12 weeks of analgesic use for OA of the knee or hip
History of regular use of analgesic medications for OA pain

Key Exclusion Criteria:

History or presence at the screening visit of non OA inflammatory joint disease
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
Signs or symptoms of carpal tunnel syndrome within 6 months of screening
Patient is not a candidate for MRI
Is scheduled for a joint replacement surgery to be performed during the study period
Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit.
History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
Pregnant or breast-feeding women
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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Fasinumab dosing regimen 1

Fasinumab dosing regimen 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)

Number of Participants With Any Serious TEAE

Number of Participants With Any Adverse Event (AE) up to Week 72

Number of Participants With Any Serious AE up to Week 72

Number of Participants With Adjudicated Arthropathy (AA)

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.

Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria

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.

Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation

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).

Number of Participants With Sympathetic Nervous System (SNS) Dysfunction

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.

Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery

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.

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up 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.

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-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.

Number of Participants With Anti-drug Antibody (ADA) 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.

Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score

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.

Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score

Secondary Outcome Measures

Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis

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).

Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score

Full Information

NCT ID

NCT02683239

First Posted

January 28, 2016

Last Updated

October 11, 2023

Sponsor

Regeneron Pharmaceuticals

Collaborators

Teva Pharmaceutical Industries, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02683239

Brief Title

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

Acronym

FACT LTS & OA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

February 17, 2016 (Actual)

Primary Completion Date

December 1, 2020 (Actual)

Study Completion Date

June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Teva Pharmaceutical Industries, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee or Hip

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5331 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fasinumab dosing regimen 1

Arm Type

Experimental

Arm Title

Fasinumab dosing regimen 2

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fasinumab

Other Intervention Name(s)

REGN475

Intervention Description

Participants will receive sub-cutaneous (SC) injections of fasinumab

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive sub-cutaneous (SC) injections of matching placebo

Primary Outcome Measure Information:

Title

Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)

Time Frame

Baseline up to week 52

Title

Number of Participants With Any Serious TEAE

Time Frame

Baseline up to week 52

Title

Number of Participants With Any Adverse Event (AE) up to Week 72

Time Frame

Baseline up to week 72

Title

Number of Participants With Any Serious AE up to Week 72

Time Frame

Baseline up to week 72

Title

Number of Participants With Adjudicated Arthropathy (AA)

Description

Time Frame

Baseline up to week 52 and week 72

Title

Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria

Description

Time Frame

Baseline up to week 52 and week 72

Title

Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation

Description

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).

Time Frame

Baseline up to week 72

Title

Number of Participants With Sympathetic Nervous System (SNS) Dysfunction

Description

Time Frame

Baseline up to week 72

Title

Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery

Description

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.

Time Frame

Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)

Title

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52

Description

Time Frame

Baseline to week 52

Title

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72

Description

Time Frame

End of treatment up to week 72

Title

Number of Participants With Anti-drug Antibody (ADA) up to Week 72

Description

Time Frame

Baseline up to week 72

Title

Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score

Description

Time Frame

Baseline to Week 16

Title

Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score

Description

Time Frame

Baseline to Week 16

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis

Description

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).

Time Frame

Baseline to Week 16

Title

Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score

Description

Time Frame

Baseline to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Male or female ≥18 years of age at the screening visit 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 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 A history of 12 weeks of analgesic use for OA of the knee or hip History of regular use of analgesic medications for OA pain Key Exclusion Criteria: History or presence at the screening visit of non OA inflammatory joint disease 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 Signs or symptoms of carpal tunnel syndrome within 6 months of screening Patient is not a candidate for MRI Is scheduled for a joint replacement surgery to be performed during the study period Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy Pregnant or breast-feeding women 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Regeneron Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Regeneron Investigational Site #1

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Regeneron Investigational Site #2

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Regeneron Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85308

Country

United States

Facility Name

Regeneron Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85213

Country

United States

Facility Name

Regeneron Investigational Site (4 locations)

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Regeneron Investigational Site

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Regeneron Investigational Site (2 locations)

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Regeneron Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Regeneron Investigational Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Regeneron Investigational Site

City

Carlsbad

State/Province

California

ZIP/Postal Code

92008

Country

United States

Facility Name

Regeneron Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Regeneron Investigational Site

City

San Marcos

State/Province

California

ZIP/Postal Code

92078

Country

United States

Facility Name

Regeneron Investigational Site

City

Vista

State/Province

California

ZIP/Postal Code

92083

Country

United States

Facility Name

Regeneron Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80014

Country

United States

Facility Name

Regeneron Investigational Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

Regeneron Investigational Site

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Regeneron Investigational Site

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80127

Country

United States

Facility Name

Regeneron Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Regeneron Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

Regeneron Investigational Site

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Regeneron Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Regeneron Investigational Site (3 locations)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60602

Country

United States

Facility Name

Regeneron Investigational Site

City

Evansville

State/Province

Illinois

ZIP/Postal Code

47714

Country

United States

Facility Name

Regeneron Investigational Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

64114

Country

United States

Facility Name

Regeneron Investigational Site

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

Regeneron Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Regeneron Investigational Site

City

Richfield

State/Province

Minnesota

ZIP/Postal Code

55423

Country

United States

Facility Name

Regeneron Investigational Site #1

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Regeneron Investigational Site #2

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Regeneron Investigational Site

City

Elkhorn

State/Province

Nebraska

ZIP/Postal Code

68022

Country

United States

Facility Name

Regeneron Investigational Site

City

Fremont

State/Province

Nebraska

ZIP/Postal Code

68025

Country

United States

Facility Name

Regeneron Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Regeneron Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Regeneron Investigational Site

City

Jamaica

State/Province

New York

ZIP/Postal Code

11432

Country

United States

Facility Name

Regeneron Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10036

Country

United States

Facility Name

Regeneron Investigational Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Regeneron Investigational Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Regeneron Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Regeneron Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

Regeneron Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73119

Country

United States

Facility Name

Regeneron Investigational Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Regeneron Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Regeneron Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Regeneron Investigational Site #1

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Regeneron Investigational Site #2

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Regeneron Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

Regeneron Investigational Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79424

Country

United States

Facility Name

Regeneron Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Regeneron Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Regeneron Investigational Site

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Regeneron Investigational Site #1

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Regeneron Investigational Site #2

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Regeneron Investigational Site #3

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

Regeneron Investigational Site #1

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

Regeneron Investigational Site #2

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Regeneron Investigational Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Regeneron Investigational Site

City

Santiago

ZIP/Postal Code

8331143

Country

Chile

Facility Name

Regeneron Investigational Site

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Regeneron Investigational Site

City

Medellin

ZIP/Postal Code

50003

Country

Colombia

Facility Name

Regeneron Investigational Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Regeneron Investigational Site

City

Ballerup

ZIP/Postal Code

2750

Country

Denmark

Facility Name

Regeneron Investigational Site

City

Vejle

ZIP/Postal Code

DK 7100

Country

Denmark

Facility Name

Regeneron Investigational Site

City

Paide

ZIP/Postal Code

72713

Country

Estonia

Facility Name

Regeneron Investigational Site

City

Tallinn

ZIP/Postal Code

10128

Country

Estonia

Facility Name

Regeneron Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

Regeneron Investigational Site

City

Berlin

ZIP/Postal Code

1267

Country

Germany

Facility Name

Regeneron Investigational Sites

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Regeneron Investigational Site

City

Frankfurt

ZIP/Postal Code

60313

Country

Germany

Facility Name

Regeneron Investigational Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Regeneron Investigational Site

City

Central

Country

Hong Kong

Facility Name

Regeneron Investigational Site

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Regeneron Investigational Site

City

Debrecen

ZIP/Postal Code

4025

Country

Hungary

Facility Name

Regeneron Investigational Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Regeneron Investigational Site

City

Hatvan

ZIP/Postal Code

3000

Country

Hungary

Facility Name

Regeneron Investigational Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Regeneron Investigational Site

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Regeneron Investigational Site

City

Naples

ZIP/Postal Code

80138

Country

Italy

Facility Name

Regeneron Investigational Site

City

Alytus

ZIP/Postal Code

LT-62114

Country

Lithuania

Facility Name

Regeneron Investigational Site

City

Kaunas

ZIP/Postal Code

48259

Country

Lithuania

Facility Name

Regeneron Investigational Site

City

Vilnius

ZIP/Postal Code

10323

Country

Lithuania

Facility Name

Regeneron Investigational Site

City

Šiauliai

ZIP/Postal Code

LT-76231

Country

Lithuania

Facility Name

Regeneron Investigational Site

City

Mexicali

State/Province

Baja Californina

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Cuauhtemoc

State/Province

Ciudad De Mexico

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Cuauhtémoc

State/Province

Ciudad De Mexico

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Distrito Federal

State/Province

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

11850

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44660

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Cuauhtemoc

State/Province

Mexico City

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62290

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

C.P. 97070

Country

Mexico

Facility Name

Regeneron Investigational Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Regeneron Investigational Site

City

Gdańsk

ZIP/Postal Code

80-382

Country

Poland

Facility Name

Regeneron Investigational Site

City

Gdynia

ZIP/Postal Code

81-537

Country

Poland

Facility Name

Regeneron Investigational Site

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Regeneron Investigational Site

City

Kraków

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Regeneron Investigational Site

City

Poznań

ZIP/Postal Code

60-702

Country

Poland

Facility Name

Regeneron Investigational Site #1

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Regeneron Investigational Site #2

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Regeneron Investigational Site

City

Wrocław

ZIP/Postal Code

50-381

Country

Poland

Facility Name

Regeneron Investigational Site

City

Łódź

ZIP/Postal Code

90-368

Country

Poland

Facility Name

Regeneron Investigational Site #2

City

Bucharest

ZIP/Postal Code

021611

Country

Romania

Facility Name

Regeneron Investigational Site #1

City

Bucharest

ZIP/Postal Code

30463

Country

Romania

Facility Name

Regeneron Investigational Site

City

Kazan'

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Regeneron Investigational Site

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Regeneron Investigational Site

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Regeneron Investigational Site

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Regeneron Investigational Site #2

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Regeneron Investigational Site #1

City

Yaroslavl

ZIP/Postal Code

150007

Country

Russian Federation

Facility Name

Regeneron Investigational Site #1

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Regeneron Investigational Site #2

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Regeneron Investigational Site

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Regeneron Investigational Site

City

Cape Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Regeneron Investigational Site

City

Kempton Park

ZIP/Postal Code

1619

Country

South Africa

Facility Name

Regeneron Investigational Site

City

Parow

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Regeneron Investigational Site

City

Port Elizabeth

ZIP/Postal Code

6001

Country

South Africa

Facility Name

Regeneron Investigational Site

City

Pretoria

ZIP/Postal Code

0122

Country

South Africa

Facility Name

Regeneron Investigational Site

City

Roodepoort

ZIP/Postal Code

1724

Country

South Africa

Facility Name

Regeneron Investigational Site

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Regeneron Investigational Site

City

Soweto

ZIP/Postal Code

1818

Country

South Africa

Facility Name

Regeneron Investigational Site

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Regeneron Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Regeneron Investigational Site

City

Madrid

ZIP/Postal Code

28100

Country

Spain

Facility Name

Regeneron Investigational Site

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Regeneron Investigational Site

City

Malmo

State/Province

Skane

ZIP/Postal Code

211 52

Country

Sweden

Facility Name

Regeneron Investigational Site

City

Boras

ZIP/Postal Code

50630

Country

Sweden

Facility Name

Regeneron Investigational Site

City

Goteburg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Regeneron Investigational Site

City

Helsingborg

ZIP/Postal Code

25220

Country

Sweden

Facility Name

Regeneron Investigational Site

City

Linkoping

ZIP/Postal Code

587 58

Country

Sweden

Facility Name

Regeneron Investigational Site

City

Lund

ZIP/Postal Code

222 22

Country

Sweden

Facility Name

Regeneron Investigational Site

City

Uppsala

ZIP/Postal Code

75237

Country

Sweden

Facility Name

Regeneron Investigational Site

City

Vällingby

ZIP/Postal Code

16268

Country

Sweden

Facility Name

Regeneron Investigational Site

City

Cherkasy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

Regeneron Investigational Site #3

City

Kyiv

ZIP/Postal Code

02002

Country

Ukraine

Facility Name

Regeneron Investigational Site #1

City

Kyiv

ZIP/Postal Code

03037

Country

Ukraine

Facility Name

Regeneron Investigational Site #2

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Regeneron Investigational Site

City

Lviv

ZIP/Postal Code

79495

Country

Ukraine

Facility Name

Regeneron Investigational Site

City

Birmingham

ZIP/Postal Code

B15 2SQ

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Chorley

ZIP/Postal Code

PR7 7NA

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Glasgow

ZIP/Postal Code

G20 0SP

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Hexham

ZIP/Postal Code

NE46 1QJ

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Liverpool

ZIP/Postal Code

L22 0LG

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Manchester

ZIP/Postal Code

M15 6SE

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Reading

ZIP/Postal Code

RG2 0TG

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Romford

ZIP/Postal Code

RM1 3PJ

Country

United Kingdom

Facility Name

Regeneron Investigational Site

City

Sidcup

ZIP/Postal Code

DA14 6LT

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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

Osteoarthritis of the Knee or Hip

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial