- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02683239
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5331
Phase
- 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
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Burgas, Bulgaria, 8000
- Regeneron Investigational Site
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Plovdiv, Bulgaria, 4000
- Regeneron Investigational Site #1
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Plovdiv, Bulgaria, 4002
- Regeneron Investigational Site #2
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Plovdiv, Bulgaria, 4004
- Regeneron Investigational Site #3
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Sofia, Bulgaria, 1000
- Regeneron Investigational Site #1
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Sofia, Bulgaria, 1612
- Regeneron Investigational Site #2
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Stara Zagora, Bulgaria, 6000
- Regeneron Investigational Site
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Santiago, Chile, 8331143
- Regeneron Investigational Site
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Bogota, Colombia, 110221
- Regeneron Investigational Site
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Medellin, Colombia, 50003
- Regeneron Investigational Site
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Aalborg, Denmark, 9000
- Regeneron Investigational Site
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Ballerup, Denmark, 2750
- Regeneron Investigational Site
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Vejle, Denmark, DK 7100
- Regeneron Investigational Site
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Paide, Estonia, 72713
- Regeneron Investigational Site
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Tallinn, Estonia, 10128
- Regeneron Investigational Site
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Berlin, Germany, 1267
- Regeneron Investigational Site
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Bochum, Germany, 44787
- Regeneron Investigational Sites
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Frankfurt, Germany, 60313
- Regeneron Investigational Site
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Magdeburg, Germany, 39120
- Regeneron Investigational Site
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Sachsen
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Leipzig, Sachsen, Germany, 04103
- Regeneron Investigational Site
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Central, Hong Kong
- Regeneron Investigational Site
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Budapest, Hungary, 1036
- Regeneron Investigational Site
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Debrecen, Hungary, 4025
- Regeneron Investigational Site
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Gyula, Hungary, 5700
- Regeneron Investigational Site
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Hatvan, Hungary, 3000
- Regeneron Investigational Site
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Zalaegerszeg, Hungary, 8900
- Regeneron Investigational Site
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Firenze, Italy, 50139
- Regeneron Investigational Site
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Naples, Italy, 80138
- Regeneron Investigational Site
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Alytus, Lithuania, LT-62114
- Regeneron Investigational Site
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Kaunas, Lithuania, 48259
- Regeneron Investigational Site
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Vilnius, Lithuania, 10323
- Regeneron Investigational Site
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Šiauliai, Lithuania, LT-76231
- Regeneron Investigational Site
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Baja Californina
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Mexicali, Baja Californina, Mexico, 21100
- Regeneron Investigational Site
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Ciudad De Mexico
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Cuauhtemoc, Ciudad De Mexico, Mexico, 06700
- Regeneron Investigational Site
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Cuauhtémoc, Ciudad De Mexico, Mexico, 06700
- Regeneron Investigational Site
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DF
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Distrito Federal, DF, Mexico, 03100
- Regeneron Investigational Site
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Distrito Federal
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Mexico, Distrito Federal, Mexico, 11850
- Regeneron Investigational Site
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Jalisco
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Guadalajara, Jalisco, Mexico, 44160
- Regeneron Investigational Site
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Guadalajara, Jalisco, Mexico, 44660
- Regeneron Investigational Site
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Mexico City
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Cuauhtemoc, Mexico City, Mexico, 06100
- Regeneron Investigational Site
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Morelos
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Cuernavaca, Morelos, Mexico, 62290
- Regeneron Investigational Site
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Sinaloa
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Culiacan, Sinaloa, Mexico, 80000
- Regeneron Investigational Site
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Yucatan
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Merida, Yucatan, Mexico, 97000
- Regeneron Investigational Site
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Merida, Yucatan, Mexico, C.P. 97070
- Regeneron Investigational Site
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Lima, Peru, 27
- Regeneron Investigational Site
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Gdańsk, Poland, 80-382
- Regeneron Investigational Site
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Gdynia, Poland, 81-537
- Regeneron Investigational Site
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Katowice, Poland, 40-040
- Regeneron Investigational Site
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Kraków, Poland, 31-501
- Regeneron Investigational Site
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Poznań, Poland, 60-702
- Regeneron Investigational Site
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Warszawa, Poland, 01-192
- Regeneron Investigational Site #1
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Warszawa, Poland, 01-192
- Regeneron Investigational Site #2
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Wrocław, Poland, 50-381
- Regeneron Investigational Site
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Łódź, Poland, 90-368
- Regeneron Investigational Site
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Bucharest, Romania, 021611
- Regeneron Investigational Site #2
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Bucharest, Romania, 30463
- Regeneron Investigational Site #1
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Kazan', Russian Federation, 420012
- Regeneron Investigational Site
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Novosibirsk, Russian Federation, 630091
- Regeneron Investigational Site
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Samara, Russian Federation, 443095
- Regeneron Investigational Site
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Tomsk, Russian Federation, 634050
- Regeneron Investigational Site
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Yaroslavl, Russian Federation, 150003
- Regeneron Investigational Site #2
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Yaroslavl, Russian Federation, 150007
- Regeneron Investigational Site #1
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Bloemfontein, South Africa, 9301
- Regeneron Investigational Site
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Cape Town, South Africa, 7530
- Regeneron Investigational Site
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Kempton Park, South Africa, 1619
- Regeneron Investigational Site
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Parow, South Africa, 7500
- Regeneron Investigational Site
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Port Elizabeth, South Africa, 6001
- Regeneron Investigational Site
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Pretoria, South Africa, 0122
- Regeneron Investigational Site
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Roodepoort, South Africa, 1724
- Regeneron Investigational Site
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Somerset West, South Africa, 7130
- Regeneron Investigational Site
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Soweto, South Africa, 1818
- Regeneron Investigational Site
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Gauteng
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Pretoria, Gauteng, South Africa, 0184
- Regeneron Investigational Site #1
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Pretoria, Gauteng, South Africa, 0184
- Regeneron Investigational Site #2
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A Coruna, Spain, 15006
- Regeneron Investigational Site
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Barcelona, Spain, 08025
- Regeneron Investigational Site
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Madrid, Spain, 28100
- Regeneron Investigational Site
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Sevilla, Spain, 41010
- Regeneron Investigational Site
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Boras, Sweden, 50630
- Regeneron Investigational Site
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Goteburg, Sweden, 413 45
- Regeneron Investigational Site
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Helsingborg, Sweden, 25220
- Regeneron Investigational Site
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Linkoping, Sweden, 587 58
- Regeneron Investigational Site
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Lund, Sweden, 222 22
- Regeneron Investigational Site
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Uppsala, Sweden, 75237
- Regeneron Investigational Site
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Vällingby, Sweden, 16268
- Regeneron Investigational Site
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Skane
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Malmo, Skane, Sweden, 211 52
- Regeneron Investigational Site
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Cherkasy, Ukraine, 18009
- Regeneron Investigational Site
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Kyiv, Ukraine, 02002
- Regeneron Investigational Site #3
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Kyiv, Ukraine, 03037
- Regeneron Investigational Site #1
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Kyiv, Ukraine, 03049
- Regeneron Investigational Site #2
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Lviv, Ukraine, 79495
- Regeneron Investigational Site
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Birmingham, United Kingdom, B15 2SQ
- Regeneron Investigational Site
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Chorley, United Kingdom, PR7 7NA
- Regeneron Investigational Site
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Glasgow, United Kingdom, G20 0SP
- Regeneron Investigational Site
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Hexham, United Kingdom, NE46 1QJ
- Regeneron Investigational Site
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Liverpool, United Kingdom, L22 0LG
- Regeneron Investigational Site
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Manchester, United Kingdom, M15 6SE
- Regeneron Investigational Site
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Middlesex, United Kingdom, HA6 2RN
- Regeneron Investigational Site
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Reading, United Kingdom, RG2 0TG
- Regeneron Investigational Site
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Romford, United Kingdom, RM1 3PJ
- Regeneron Investigational Site
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Sidcup, United Kingdom, DA14 6LT
- Regeneron Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35211
- Regeneron Investigational Site
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Arizona
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Chandler, Arizona, United States, 85224
- Regeneron Investigational Site #1
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Chandler, Arizona, United States, 85224
- Regeneron Investigational Site #2
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Glendale, Arizona, United States, 85308
- Regeneron Investigational Site
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Mesa, Arizona, United States, 85213
- Regeneron Investigational Site
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Phoenix, Arizona, United States, 85018
- Regeneron Investigational Site (4 locations)
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Tempe, Arizona, United States, 85224
- Regeneron Investigational Site
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Tucson, Arizona, United States, 85712
- Regeneron Investigational Site (2 locations)
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Regeneron Investigational Site
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California
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Beverly Hills, California, United States, 90211
- Regeneron Investigational Site
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Carlsbad, California, United States, 92008
- Regeneron Investigational Site
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San Diego, California, United States, 92103
- Regeneron Investigational Site
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San Marcos, California, United States, 92078
- Regeneron Investigational Site
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Vista, California, United States, 92083
- Regeneron Investigational Site
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Colorado
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Aurora, Colorado, United States, 80014
- Regeneron Investigational Site
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Colorado Springs, Colorado, United States, 80909
- Regeneron Investigational Site
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Golden, Colorado, United States, 80401
- Regeneron Investigational Site
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Littleton, Colorado, United States, 80127
- Regeneron Investigational Site
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Florida
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Clearwater, Florida, United States, 33765
- Regeneron Investigational Site
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Orlando, Florida, United States, 32801
- Regeneron Investigational Site
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Pinellas Park, Florida, United States, 33781
- Regeneron Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30328
- Regeneron Investigational Site
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Illinois
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Chicago, Illinois, United States, 60602
- Regeneron Investigational Site (3 locations)
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Evansville, Illinois, United States, 47714
- Regeneron Investigational Site
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Kansas
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Kansas City, Kansas, United States, 64114
- Regeneron Investigational Site
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Maryland
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Frederick, Maryland, United States, 21702
- Regeneron Investigational Site
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Massachusetts
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Worcester, Massachusetts, United States, 01605
- Regeneron Investigational Site
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Minnesota
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Richfield, Minnesota, United States, 55423
- Regeneron Investigational Site
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Missouri
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Saint Louis, Missouri, United States, 63141
- Regeneron Investigational Site #1
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Saint Louis, Missouri, United States, 63141
- Regeneron Investigational Site #2
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Nebraska
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Elkhorn, Nebraska, United States, 68022
- Regeneron Investigational Site
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Fremont, Nebraska, United States, 68025
- Regeneron Investigational Site
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Omaha, Nebraska, United States, 68144
- Regeneron Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89128
- Regeneron Investigational Site
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New York
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Jamaica, New York, United States, 11432
- Regeneron Investigational Site
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New York, New York, United States, 10036
- Regeneron Investigational Site
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North Carolina
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High Point, North Carolina, United States, 27262
- Regeneron Investigational Site
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Ohio
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Akron, Ohio, United States, 44311
- Regeneron Investigational Site
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Cincinnati, Ohio, United States, 45219
- Regeneron Investigational Site
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Columbus, Ohio, United States, 43212
- Regeneron Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73119
- Regeneron Investigational Site
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Regeneron Investigational Site
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South Carolina
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Anderson, South Carolina, United States, 29621
- Regeneron Investigational Site
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Greer, South Carolina, United States, 29651
- Regeneron Investigational Site
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Texas
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Dallas, Texas, United States, 75234
- Regeneron Investigational Site #1
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Dallas, Texas, United States, 75234
- Regeneron Investigational Site #2
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Houston, Texas, United States, 77008
- Regeneron Investigational Site
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Lubbock, Texas, United States, 79424
- Regeneron Investigational Site
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Plano, Texas, United States, 75093
- Regeneron Investigational Site
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San Antonio, Texas, United States, 78229
- Regeneron Investigational Site
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
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 |
Intervention / Treatment |
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Experimental: Placebo
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Participants will receive sub-cutaneous (SC) injections of matching placebo
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Experimental: Fasinumab dosing regimen 1
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Participants will receive sub-cutaneous (SC) injections of fasinumab
Other Names:
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Experimental: Fasinumab dosing regimen 2
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Participants will receive sub-cutaneous (SC) injections of fasinumab
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)
Time Frame: Baseline up to week 52
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Baseline up to week 52
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Number of Participants With Any Serious TEAE
Time Frame: Baseline up to week 52
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Baseline up to week 52
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Number of Participants With Any Adverse Event (AE) up to Week 72
Time Frame: Baseline up to week 72
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Baseline up to week 72
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Number of Participants With Any Serious AE up to Week 72
Time Frame: Baseline up to week 72
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Baseline up to week 72
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Number of Participants With Adjudicated Arthropathy (AA)
Time Frame: Baseline up to week 52 and week 72
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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.
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Baseline up to week 52 and week 72
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Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria
Time Frame: Baseline up to week 52 and week 72
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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.
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Baseline up to week 52 and week 72
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Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation
Time Frame: Baseline up to week 72
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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).
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Baseline up to week 72
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Number of Participants With Sympathetic Nervous System (SNS) Dysfunction
Time Frame: Baseline up to week 72
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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.
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Baseline up to week 72
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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)
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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.
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Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)
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Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52
Time Frame: Baseline to week 52
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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.
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Baseline to week 52
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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
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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.
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End of treatment up to week 72
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Number of Participants With Anti-drug Antibody (ADA) up to Week 72
Time Frame: Baseline up to week 72
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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.
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Baseline up to week 72
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Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score
Time Frame: Baseline to Week 16
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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.
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Baseline to Week 16
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Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score
Time Frame: Baseline to Week 16
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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.
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Baseline to Week 16
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Secondary Outcome Measures
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
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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).
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Baseline to Week 16
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Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score
Time Frame: Baseline to Week 16
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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
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Baseline to Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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)
February 17, 2016
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
June 15, 2021
Study Registration Dates
First Submitted
January 28, 2016
First Submitted That Met QC Criteria
February 16, 2016
First Posted (Estimated)
February 17, 2016
Study Record Updates
Last Update Posted (Actual)
October 13, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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-
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-
Regeneron PharmaceuticalsTeva Pharmaceutical Industries, Ltd.CompletedOsteoarthritis, Knee | Osteoarthritis, HipUnited States, Poland, United Kingdom