Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
NCT ID: NCT02683239
Last Updated: 2023-10-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
5331 participants
INTERVENTIONAL
2016-02-17
2021-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
NCT03304379
Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
NCT03285646
A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
NCT03161093
Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee
NCT03691974
Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip
NCT03949673
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fasinumab dosing regimen 1
Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Fasinumab dosing regimen 2
Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Placebo
Placebo
Participants will receive sub-cutaneous (SC) injections of matching placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Placebo
Participants will receive sub-cutaneous (SC) injections of matching placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teva Pharmaceutical Industries, Ltd.
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Regeneron Investigational Site
Birmingham, Alabama, United States
Regeneron Investigational Site #1
Chandler, Arizona, United States
Regeneron Investigational Site #2
Chandler, Arizona, United States
Regeneron Investigational Site
Glendale, Arizona, United States
Regeneron Investigational Site
Mesa, Arizona, United States
Regeneron Investigational Site (4 locations)
Phoenix, Arizona, United States
Regeneron Investigational Site
Tempe, Arizona, United States
Regeneron Investigational Site (2 locations)
Tucson, Arizona, United States
Regeneron Investigational Site
Little Rock, Arkansas, United States
Regeneron Investigational Site
Beverly Hills, California, United States
Regeneron Investigational Site
Carlsbad, California, United States
Regeneron Investigational Site
San Diego, California, United States
Regeneron Investigational Site
San Marcos, California, United States
Regeneron Investigational Site
Vista, California, United States
Regeneron Investigational Site
Aurora, Colorado, United States
Regeneron Investigational Site
Colorado Springs, Colorado, United States
Regeneron Investigational Site
Golden, Colorado, United States
Regeneron Investigational Site
Littleton, Colorado, United States
Regeneron Investigational Site
Clearwater, Florida, United States
Regeneron Investigational Site
Orlando, Florida, United States
Regeneron Investigational Site
Pinellas Park, Florida, United States
Regeneron Investigational Site
Atlanta, Georgia, United States
Regeneron Investigational Site (3 locations)
Chicago, Illinois, United States
Regeneron Investigational Site
Evansville, Illinois, United States
Regeneron Investigational Site
Kansas City, Kansas, United States
Regeneron Investigational Site
Frederick, Maryland, United States
Regeneron Investigational Site
Worcester, Massachusetts, United States
Regeneron Investigational Site
Richfield, Minnesota, United States
Regeneron Investigational Site #1
St Louis, Missouri, United States
Regeneron Investigational Site #2
St Louis, Missouri, United States
Regeneron Investigational Site
Elkhorn, Nebraska, United States
Regeneron Investigational Site
Fremont, Nebraska, United States
Regeneron Investigational Site
Omaha, Nebraska, United States
Regeneron Investigational Site
Las Vegas, Nevada, United States
Regeneron Investigational Site
Jamaica, New York, United States
Regeneron Investigational Site
New York, New York, United States
Regeneron Investigational Site
High Point, North Carolina, United States
Regeneron Investigational Site
Akron, Ohio, United States
Regeneron Investigational Site
Cincinnati, Ohio, United States
Regeneron Investigational Site
Columbus, Ohio, United States
Regeneron Investigational Site
Oklahoma City, Oklahoma, United States
Regeneron Investigational Site
Duncansville, Pennsylvania, United States
Regeneron Investigational Site
Anderson, South Carolina, United States
Regeneron Investigational Site
Greer, South Carolina, United States
Regeneron Investigational Site #1
Dallas, Texas, United States
Regeneron Investigational Site #2
Dallas, Texas, United States
Regeneron Investigational Site
Houston, Texas, United States
Regeneron Investigational Site
Lubbock, Texas, United States
Regeneron Investigational Site
Plano, Texas, United States
Regeneron Investigational Site
San Antonio, Texas, United States
Regeneron Investigational Site
Burgas, , Bulgaria
Regeneron Investigational Site #1
Plovdiv, , Bulgaria
Regeneron Investigational Site #2
Plovdiv, , Bulgaria
Regeneron Investigational Site #3
Plovdiv, , Bulgaria
Regeneron Investigational Site #1
Sofia, , Bulgaria
Regeneron Investigational Site #2
Sofia, , Bulgaria
Regeneron Investigational Site
Stara Zagora, , Bulgaria
Regeneron Investigational Site
Santiago, , Chile
Regeneron Investigational Site
Bogotá, , Colombia
Regeneron Investigational Site
Medellín, , Colombia
Regeneron Investigational Site
Aalborg, , Denmark
Regeneron Investigational Site
Ballerup Municipality, , Denmark
Regeneron Investigational Site
Vejle, , Denmark
Regeneron Investigational Site
Paide, , Estonia
Regeneron Investigational Site
Tallinn, , Estonia
Regeneron Investigational Site
Leipzig, Saxony, Germany
Regeneron Investigational Site
Berlin, , Germany
Regeneron Investigational Sites
Bochum, , Germany
Regeneron Investigational Site
Frankfurt, , Germany
Regeneron Investigational Site
Magdeburg, , Germany
Regeneron Investigational Site
Central, , Hong Kong
Regeneron Investigational Site
Budapest, , Hungary
Regeneron Investigational Site
Debrecen, , Hungary
Regeneron Investigational Site
Gyula, , Hungary
Regeneron Investigational Site
Hatvan, , Hungary
Regeneron Investigational Site
Zalaegerszeg, , Hungary
Regeneron Investigational Site
Florence, , Italy
Regeneron Investigational Site
Naples, , Italy
Regeneron Investigational Site
Alytus, , Lithuania
Regeneron Investigational Site
Kaunas, , Lithuania
Regeneron Investigational Site
Šiauliai, , Lithuania
Regeneron Investigational Site
Vilnius, , Lithuania
Regeneron Investigational Site
Mexicali, Baja Californina, Mexico
Regeneron Investigational Site
Guadalajara, Jalisco, Mexico
Regeneron Investigational Site
Guadalajara, Jalisco, Mexico
Regeneron Investigational Site
Cuauhtémoc, Mexico City, Mexico
Regeneron Investigational Site
Cuauhtémoc, Mexico City, Mexico
Regeneron Investigational Site
Distrito Federal, Mexico City, Mexico
Regeneron Investigational Site
Mexico City, Mexico City, Mexico
Regeneron Investigational Site
Cuernavaca, Morelos, Mexico
Regeneron Investigational Site
Culiacán, Sinaloa, Mexico
Regeneron Investigational Site
Mérida, Yucatán, Mexico
Regeneron Investigational Site
Mérida, Yucatán, Mexico
Regeneron Investigational Site
Lima, , Peru
Regeneron Investigational Site
Gdansk, , Poland
Regeneron Investigational Site
Gdynia, , Poland
Regeneron Investigational Site
Katowice, , Poland
Regeneron Investigational Site
Krakow, , Poland
Regeneron Investigational Site
Lodz, , Poland
Regeneron Investigational Site
Poznan, , Poland
Regeneron Investigational Site #1
Warsaw, , Poland
Regeneron Investigational Site #2
Warsaw, , Poland
Regeneron Investigational Site
Wroclaw, , Poland
Regeneron Investigational Site #2
Bucharest, , Romania
Regeneron Investigational Site #1
Bucharest, , Romania
Regeneron Investigational Site
Kazan', , Russia
Regeneron Investigational Site
Novosibirsk, , Russia
Regeneron Investigational Site
Samara, , Russia
Regeneron Investigational Site
Tomsk, , Russia
Regeneron Investigational Site #2
Yaroslavl, , Russia
Regeneron Investigational Site #1
Yaroslavl, , Russia
Regeneron Investigational Site #1
Pretoria, Gauteng, South Africa
Regeneron Investigational Site #2
Pretoria, Gauteng, South Africa
Regeneron Investigational Site
Bloemfontein, , South Africa
Regeneron Investigational Site
Cape Town, , South Africa
Regeneron Investigational Site
Kempton Park, , South Africa
Regeneron Investigational Site
Parow, , South Africa
Regeneron Investigational Site
Port Elizabeth, , South Africa
Regeneron Investigational Site
Pretoria, , South Africa
Regeneron Investigational Site
Roodepoort, , South Africa
Regeneron Investigational Site
Somerset West, , South Africa
Regeneron Investigational Site
Soweto, , South Africa
Regeneron Investigational Site
A Coruña, , Spain
Regeneron Investigational Site
Barcelona, , Spain
Regeneron Investigational Site
Madrid, , Spain
Regeneron Investigational Site
Seville, , Spain
Regeneron Investigational Site
Malmo, Skåne County, Sweden
Regeneron Investigational Site
Borås, , Sweden
Regeneron Investigational Site
Gothenburg, , Sweden
Regeneron Investigational Site
Helsingborg, , Sweden
Regeneron Investigational Site
Linköping, , Sweden
Regeneron Investigational Site
Lund, , Sweden
Regeneron Investigational Site
Uppsala, , Sweden
Regeneron Investigational Site
Vällingby, , Sweden
Regeneron Investigational Site
Cherkasy, , Ukraine
Regeneron Investigational Site #3
Kyiv, , Ukraine
Regeneron Investigational Site #1
Kyiv, , Ukraine
Regeneron Investigational Site #2
Kyiv, , Ukraine
Regeneron Investigational Site
Lviv, , Ukraine
Regeneron Investigational Site
Birmingham, , United Kingdom
Regeneron Investigational Site
Chorley, , United Kingdom
Regeneron Investigational Site
Glasgow, , United Kingdom
Regeneron Investigational Site
Hexham, , United Kingdom
Regeneron Investigational Site
Liverpool, , United Kingdom
Regeneron Investigational Site
Manchester, , United Kingdom
Regeneron Investigational Site
Middlesex, , United Kingdom
Regeneron Investigational Site
Reading, , United Kingdom
Regeneron Investigational Site
Romford, , United Kingdom
Regeneron Investigational Site
Sidcup, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-003783-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R475-PN-1523
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.