Clinical trial NCT02683239: Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee or Hip
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Teva Pharmaceutical Industries, Ltd.
First posted: 2016-02-17
Enrollment: 5331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)
timeFrame: Baseline up to week 52
measure: Number of Participants With Any Serious TEAE
timeFrame: Baseline up to week 52
measure: Number of Participants With Any Adverse Event (AE) up to Week 72
timeFrame: Baseline up to week 72
measure: Number of Participants With Any Serious AE up to Week 72
timeFrame: Baseline up to week 72
measure: Number of Participants With Adjudicated Arthropathy (AA)
timeFrame: Baseline up to week 52 and week 72
measure: Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria
timeFrame: Baseline up to week 52 and week 72
measure: Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation
timeFrame: Baseline up to week 72
measure: Number of Participants With Sympathetic Nervous System (SNS) Dysfunction
timeFrame: Baseline up to week 72
measure: Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery
timeFrame: Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)
measure: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52
timeFrame: Baseline to week 52
measure: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72
timeFrame: End of treatment up to week 72
measure: Number of Participants With Anti-drug Antibody (ADA) up to Week 72
timeFrame: Baseline up to week 72
measure: Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis
timeFrame: Baseline to Week 16
measure: Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regeneron Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Regeneron Investigational Site #1
state: Arizona
city: Chandler
country: United States
facility: Regeneron Investigational Site #2
state: Arizona
city: Glendale
country: United States
facility: Regeneron Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Regeneron Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Regeneron Investigational Site (4 locations)
state: Arizona
city: Tempe
country: United States
facility: Regeneron Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Regeneron Investigational Site (2 locations)
state: Arizona
city: Little Rock
country: United States
facility: Regeneron Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Regeneron Investigational Site
state: California
city: Carlsbad
country: United States
facility: Regeneron Investigational Site
state: California
city: San Diego
country: United States
facility: Regeneron Investigational Site
state: California
city: San Marcos
country: United States
facility: Regeneron Investigational Site
state: California
city: Vista
country: United States
facility: Regeneron Investigational Site
state: California
city: Aurora
country: United States
facility: Regeneron Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Regeneron Investigational Site
state: Colorado
city: Golden
country: United States
facility: Regeneron Investigational Site
state: Colorado
city: Littleton
country: United States
facility: Regeneron Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Orlando
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Regeneron Investigational Site (3 locations)
state: Illinois
city: Evansville
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: Regeneron Investigational Site
state: Kansas
city: Frederick
country: United States
facility: Regeneron Investigational Site
state: Maryland
city: Worcester
country: United States
facility: Regeneron Investigational Site
state: Massachusetts
city: Richfield
country: United States
facility: Regeneron Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Regeneron Investigational Site #1
state: Missouri
city: Saint Louis
country: United States
facility: Regeneron Investigational Site #2
state: Missouri
city: Elkhorn
country: United States
facility: Regeneron Investigational Site
state: Nebraska
city: Fremont
country: United States
facility: Regeneron Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Regeneron Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Regeneron Investigational Site
state: Nevada
city: Jamaica
country: United States
facility: Regeneron Investigational Site
state: New York
city: New York
country: United States
facility: Regeneron Investigational Site
state: New York
city: High Point
country: United States
facility: Regeneron Investigational Site
state: North Carolina
city: Akron
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Regeneron Investigational Site
state: Oklahoma
city: Duncansville
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Regeneron Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Regeneron Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Regeneron Investigational Site #1
state: Texas
city: Dallas
country: United States
facility: Regeneron Investigational Site #2
state: Texas
city: Houston
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Lubbock
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Plano
country: United States
facility: Regeneron Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Burgas
country: Bulgaria
facility: Regeneron Investigational Site
city: Plovdiv
country: Bulgaria
facility: Regeneron Investigational Site #1
city: Plovdiv
country: Bulgaria
facility: Regeneron Investigational Site #2
city: Plovdiv
country: Bulgaria
facility: Regeneron Investigational Site #3
city: Sofia
country: Bulgaria
facility: Regeneron Investigational Site #1
city: Sofia
country: Bulgaria
facility: Regeneron Investigational Site #2
city: Stara Zagora
country: Bulgaria
facility: Regeneron Investigational Site
city: Santiago
country: Chile
facility: Regeneron Investigational Site
city: Bogota
country: Colombia
facility: Regeneron Investigational Site
city: Medellin
country: Colombia
facility: Regeneron Investigational Site
city: Aalborg
country: Denmark
facility: Regeneron Investigational Site
city: Ballerup
country: Denmark
facility: Regeneron Investigational Site
city: Vejle
country: Denmark
facility: Regeneron Investigational Site
city: Paide
country: Estonia
facility: Regeneron Investigational Site
city: Tallinn
country: Estonia
facility: Regeneron Investigational Site
city: Leipzig
country: Germany
facility: Regeneron Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: Regeneron Investigational Site
city: Bochum
country: Germany
facility: Regeneron Investigational Sites
city: Frankfurt
country: Germany
facility: Regeneron Investigational Site
city: Magdeburg
country: Germany
facility: Regeneron Investigational Site
city: Central
country: Hong Kong
facility: Regeneron Investigational Site
city: Budapest
country: Hungary
facility: Regeneron Investigational Site
city: Debrecen
country: Hungary
facility: Regeneron Investigational Site
city: Gyula
country: Hungary
facility: Regeneron Investigational Site
city: Hatvan
country: Hungary
facility: Regeneron Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Regeneron Investigational Site
city: Firenze
country: Italy
facility: Regeneron Investigational Site
city: Naples
country: Italy
facility: Regeneron Investigational Site
city: Alytus
country: Lithuania
facility: Regeneron Investigational Site
city: Kaunas
country: Lithuania
facility: Regeneron Investigational Site
city: Vilnius
country: Lithuania
facility: Regeneron Investigational Site
city: Šiauliai
country: Lithuania
facility: Regeneron Investigational Site
city: Mexicali
country: Mexico
facility: Regeneron Investigational Site
state: Baja Californina
city: Cuauhtemoc
country: Mexico
facility: Regeneron Investigational Site
state: Ciudad De Mexico
city: Cuauhtémoc
country: Mexico
facility: Regeneron Investigational Site
state: Ciudad De Mexico
city: Distrito Federal
country: Mexico
facility: Regeneron Investigational Site
state: DF
city: Mexico
country: Mexico
facility: Regeneron Investigational Site
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Regeneron Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Regeneron Investigational Site
state: Jalisco
city: Cuauhtemoc
country: Mexico
facility: Regeneron Investigational Site
state: Mexico City
city: Cuernavaca
country: Mexico
facility: Regeneron Investigational Site
state: Morelos
city: Culiacan
country: Mexico
facility: Regeneron Investigational Site
state: Sinaloa
city: Merida
country: Mexico
facility: Regeneron Investigational Site
state: Yucatan
city: Merida
country: Mexico
facility: Regeneron Investigational Site
state: Yucatan
city: Lima
country: Peru
facility: Regeneron Investigational Site
city: Gdańsk
country: Poland
facility: Regeneron Investigational Site
city: Gdynia
country: Poland
facility: Regeneron Investigational Site
city: Katowice
country: Poland
facility: Regeneron Investigational Site
city: Kraków
country: Poland
facility: Regeneron Investigational Site
city: Poznań
country: Poland
facility: Regeneron Investigational Site
city: Warszawa
country: Poland
facility: Regeneron Investigational Site #1
city: Warszawa
country: Poland
facility: Regeneron Investigational Site #2
city: Wrocław
country: Poland
facility: Regeneron Investigational Site
city: Łódź
country: Poland
facility: Regeneron Investigational Site
city: Bucharest
country: Romania
facility: Regeneron Investigational Site #2
city: Bucharest
country: Romania
facility: Regeneron Investigational Site #1
city: Kazan'
country: Russian Federation
facility: Regeneron Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Regeneron Investigational Site
city: Samara
country: Russian Federation
facility: Regeneron Investigational Site
city: Tomsk
country: Russian Federation
facility: Regeneron Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Regeneron Investigational Site #2
city: Yaroslavl
country: Russian Federation
facility: Regeneron Investigational Site #1
city: Pretoria
country: South Africa
facility: Regeneron Investigational Site #1
state: Gauteng
city: Pretoria
country: South Africa
facility: Regeneron Investigational Site #2
state: Gauteng
city: Bloemfontein
country: South Africa
facility: Regeneron Investigational Site
city: Cape Town
country: South Africa
facility: Regeneron Investigational Site
city: Kempton Park
country: South Africa
facility: Regeneron Investigational Site
city: Parow
country: South Africa
facility: Regeneron Investigational Site
city: Port Elizabeth
country: South Africa
facility: Regeneron Investigational Site
city: Pretoria
country: South Africa
facility: Regeneron Investigational Site
city: Roodepoort
country: South Africa
facility: Regeneron Investigational Site
city: Somerset West
country: South Africa
facility: Regeneron Investigational Site
city: Soweto
country: South Africa
facility: Regeneron Investigational Site
city: A Coruna
country: Spain
facility: Regeneron Investigational Site
city: Barcelona
country: Spain
facility: Regeneron Investigational Site
city: Madrid
country: Spain
facility: Regeneron Investigational Site
city: Sevilla
country: Spain
facility: Regeneron Investigational Site
city: Malmo
country: Sweden
facility: Regeneron Investigational Site
state: Skane
city: Boras
country: Sweden
facility: Regeneron Investigational Site
city: Goteburg
country: Sweden
facility: Regeneron Investigational Site
city: Helsingborg
country: Sweden
facility: Regeneron Investigational Site
city: Linkoping
country: Sweden
facility: Regeneron Investigational Site
city: Lund
country: Sweden
facility: Regeneron Investigational Site
city: Uppsala
country: Sweden
facility: Regeneron Investigational Site
city: Vällingby
country: Sweden
facility: Regeneron Investigational Site
city: Cherkasy
country: Ukraine
facility: Regeneron Investigational Site
city: Kyiv
country: Ukraine
facility: Regeneron Investigational Site #3
city: Kyiv
country: Ukraine
facility: Regeneron Investigational Site #1
city: Kyiv
country: Ukraine
facility: Regeneron Investigational Site #2
city: Lviv
country: Ukraine
facility: Regeneron Investigational Site
city: Birmingham
country: United Kingdom
facility: Regeneron Investigational Site
city: Chorley
country: United Kingdom
facility: Regeneron Investigational Site
city: Glasgow
country: United Kingdom
facility: Regeneron Investigational Site
city: Hexham
country: United Kingdom
facility: Regeneron Investigational Site
city: Liverpool
country: United Kingdom
facility: Regeneron Investigational Site
city: Manchester
country: United Kingdom
facility: Regeneron Investigational Site
city: Middlesex
country: United Kingdom
facility: Regeneron Investigational Site
city: Reading
country: United Kingdom
facility: Regeneron Investigational Site
city: Romford
country: United Kingdom
facility: Regeneron Investigational Site
city: Sidcup
country: United Kingdom
facility: Regeneron Investigational Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: