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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02683239
Collaborator
Teva Pharmaceutical Industries, Ltd. (Industry)
5,331
Enrollment
150
Locations
3
Arms
63.9
Actual Duration (Months)
35.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
5331 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 17, 2016
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fasinumab dosing regimen 1

Drug: Fasinumab
Participants will receive sub-cutaneous (SC) injections of fasinumab
Other Names:
  • REGN475

    		•
    Experimental: Fasinumab dosing regimen 2

    Drug: Fasinumab
    Participants will receive sub-cutaneous (SC) injections of fasinumab
    Other Names:
  • REGN475

    		•
    Experimental: Placebo

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

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AEs) [Baseline to week 52]

    2. Incidence of serious adverse events (SAEs) [Baseline to week 52]

    3. Incidence of adverse events of special interest (AESI) [Baseline to week 52]

    4. Incidence of laboratory abnormalities [Baseline to week 52]

    5. Incidence of anti-fasinumab antibody formation [Baseline to week 52]

    6. Incidence of adverse events (AEs) [Baseline to week 72]

    7. Incidence of serious adverse events (SAEs) [Baseline to week 72]

    8. Incidence of adverse events of special interest (AESI) [Baseline to week 72]

    9. Incidence of laboratory abnormalities [Baseline to week 72]

    10. Incidence of anti-fasinumab antibody formation [Baseline to week 72]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regeneron Investigational Site Birmingham Alabama United States 35211
    2 Regeneron Investigational Site #1 Chandler Arizona United States 85224
    3 Regeneron Investigational Site #2 Chandler Arizona United States 85224
    4 Regeneron Investigational Site Glendale Arizona United States 85308
    5 Regeneron Investigational Site Mesa Arizona United States 85213
    6 Regeneron Investigational Site (4 locations) Phoenix Arizona United States 85018
    7 Regeneron Investigational Site Tempe Arizona United States 85224
    8 Regeneron Investigational Site (2 locations) Tucson Arizona United States 85712
    9 Regeneron Investigational Site Little Rock Arkansas United States 72205
    10 Regeneron Investigational Site Beverly Hills California United States 90211
    11 Regeneron Investigational Site Carlsbad California United States 92008
    12 Regeneron Investigational Site San Diego California United States 92103
    13 Regeneron Investigational Site San Marcos California United States 92078
    14 Regeneron Investigational Site Vista California United States 92083
    15 Regeneron Investigational Site Aurora Colorado United States 80014
    16 Regeneron Investigational Site Colorado Springs Colorado United States 80909
    17 Regeneron Investigational Site Golden Colorado United States 80401
    18 Regeneron Investigational Site Littleton Colorado United States 80127
    19 Regeneron Investigational Site Clearwater Florida United States 33765
    20 Regeneron Investigational Site Orlando Florida United States 32801
    21 Regeneron Investigational Site Pinellas Park Florida United States 33781
    22 Regeneron Investigational Site Atlanta Georgia United States 30328
    23 Regeneron Investigational Site (3 locations) Chicago Illinois United States 60602
    24 Regeneron Investigational Site Evansville Illinois United States 47714
    25 Regeneron Investigational Site Kansas City Kansas United States 64114
    26 Regeneron Investigational Site Frederick Maryland United States 21702
    27 Regeneron Investigational Site Worcester Massachusetts United States 01605
    28 Regeneron Investigational Site Richfield Minnesota United States 55423
    29 Regeneron Investigational Site #1 Saint Louis Missouri United States 63141
    30 Regeneron Investigational Site #2 Saint Louis Missouri United States 63141
    31 Regeneron Investigational Site Elkhorn Nebraska United States 68022
    32 Regeneron Investigational Site Fremont Nebraska United States 68025
    33 Regeneron Investigational Site Omaha Nebraska United States 68144
    34 Regeneron Investigational Site Las Vegas Nevada United States 89128
    35 Regeneron Investigational Site Jamaica New York United States 11432
    36 Regeneron Investigational Site New York New York United States 10036
    37 Regeneron Investigational Site High Point North Carolina United States 27262
    38 Regeneron Investigational Site Akron Ohio United States 44311
    39 Regeneron Investigational Site Cincinnati Ohio United States 45219
    40 Regeneron Investigational Site Columbus Ohio United States 43212
    41 Regeneron Investigational Site Oklahoma City Oklahoma United States 73119
    42 Regeneron Investigational Site Duncansville Pennsylvania United States 16635
    43 Regeneron Investigational Site Anderson South Carolina United States 29621
    44 Regeneron Investigational Site Greer South Carolina United States 29651
    45 Regeneron Investigational Site #1 Dallas Texas United States 75234
    46 Regeneron Investigational Site #2 Dallas Texas United States 75234
    47 Regeneron Investigational Site Houston Texas United States 77008
    48 Regeneron Investigational Site Lubbock Texas United States 79424
    49 Regeneron Investigational Site Plano Texas United States 75093
    50 Regeneron Investigational Site San Antonio Texas United States 78229
    51 Regeneron Investigational Site Burgas Bulgaria 8000
    52 Regeneron Investigational Site #1 Plovdiv Bulgaria 4000
    53 Regeneron Investigational Site #2 Plovdiv Bulgaria 4002
    54 Regeneron Investigational Site #3 Plovdiv Bulgaria 4004
    55 Regeneron Investigational Site #1 Sofia Bulgaria 1000
    56 Regeneron Investigational Site #2 Sofia Bulgaria 1612
    57 Regeneron Investigational Site Stara Zagora Bulgaria 6000
    58 Regeneron Investigational Site Santiago Chile 8331143
    59 Regeneron Investigational Site Bogota Colombia 110221
    60 Regeneron Investigational Site Medellin Colombia 50003
    61 Regeneron Investigational Site Aalborg Denmark 9000
    62 Regeneron Investigational Site Ballerup Denmark 2750
    63 Regeneron Investigational Site Vejle Denmark DK 7100
    64 Regeneron Investigational Site Paide Estonia 72713
    65 Regeneron Investigational Site Tallinn Estonia 10128
    66 Regeneron Investigational Site Leipzig Sachsen Germany 04103
    67 Regeneron Investigational Site Berlin Germany 1267
    68 Regeneron Investigational Sites Bochum Germany 44787
    69 Regeneron Investigational Site Frankfurt Germany 60313
    70 Regeneron Investigational Site Magdeburg Germany 39120
    71 Regeneron Investigational Site Central Hong Kong
    72 Regeneron Investigational Site Budapest Hungary 1036
    73 Regeneron Investigational Site Debrecen Hungary 4025
    74 Regeneron Investigational Site Gyula Hungary 5700
    75 Regeneron Investigational Site Hatvan Hungary 3000
    76 Regeneron Investigational Site Zalaegerszeg Hungary 8900
    77 Regeneron Investigational Site Firenze Italy 50139
    78 Regeneron Investigational Site Naples Italy 80138
    79 Regeneron Investigational Site Alytus Lithuania LT-62114
    80 Regeneron Investigational Site Kaunas Lithuania 48259
    81 Regeneron Investigational Site Vilnius Lithuania 10323
    82 Regeneron Investigational Site Šiauliai Lithuania LT-76231
    83 Regeneron Investigational Site Mexicali Baja Californina Mexico 21100
    84 Regeneron Investigational Site Cuauhtemoc Ciudad De Mexico Mexico 06700
    85 Regeneron Investigational Site Cuauhtémoc Ciudad De Mexico Mexico 06700
    86 Regeneron Investigational Site Distrito Federal DF Mexico 03100
    87 Regeneron Investigational Site Mexico Distrito Federal Mexico 11850
    88 Regeneron Investigational Site Guadalajara Jalisco Mexico 44160
    89 Regeneron Investigational Site Guadalajara Jalisco Mexico 44660
    90 Regeneron Investigational Site Cuauhtemoc Mexico City Mexico 06100
    91 Regeneron Investigational Site Cuernavaca Morelos Mexico 62290
    92 Regeneron Investigational Site Culiacan Sinaloa Mexico 80000
    93 Regeneron Investigational Site Merida Yucatan Mexico 97000
    94 Regeneron Investigational Site Merida Yucatan Mexico C.P. 97070
    95 Regeneron Investigational Site Lima Peru 27
    96 Regeneron Investigational Site Gdańsk Poland 80-382
    97 Regeneron Investigational Site Gdynia Poland 81-537
    98 Regeneron Investigational Site Katowice Poland 40-040
    99 Regeneron Investigational Site Kraków Poland 31-501
    100 Regeneron Investigational Site Poznań Poland 60-702
    101 Regeneron Investigational Site #1 Warszawa Poland 01-192
    102 Regeneron Investigational Site #2 Warszawa Poland 01-192
    103 Regeneron Investigational Site Wrocław Poland 50-381
    104 Regeneron Investigational Site Łódź Poland 90-368
    105 Regeneron Investigational Site #2 Bucharest Romania 021611
    106 Regeneron Investigational Site #1 Bucharest Romania 30463
    107 Regeneron Investigational Site Kazan' Russian Federation 420012
    108 Regeneron Investigational Site Novosibirsk Russian Federation 630091
    109 Regeneron Investigational Site Samara Russian Federation 443095
    110 Regeneron Investigational Site Tomsk Russian Federation 634050
    111 Regeneron Investigational Site #2 Yaroslavl Russian Federation 150003
    112 Regeneron Investigational Site #1 Yaroslavl Russian Federation 150007
    113 Regeneron Investigational Site #1 Pretoria Gauteng South Africa 0184
    114 Regeneron Investigational Site #2 Pretoria Gauteng South Africa 0184
    115 Regeneron Investigational Site Bloemfontein South Africa 9301
    116 Regeneron Investigational Site Cape Town South Africa 7530
    117 Regeneron Investigational Site Kempton Park South Africa 1619
    118 Regeneron Investigational Site Parow South Africa 7500
    119 Regeneron Investigational Site Port Elizabeth South Africa 6001
    120 Regeneron Investigational Site Pretoria South Africa 0122
    121 Regeneron Investigational Site Roodepoort South Africa 1724
    122 Regeneron Investigational Site Somerset West South Africa 7130
    123 Regeneron Investigational Site Soweto South Africa 1818
    124 Regeneron Investigational Site A Coruna Spain 15006
    125 Regeneron Investigational Site Barcelona Spain 08025
    126 Regeneron Investigational Site Madrid Spain 28100
    127 Regeneron Investigational Site Sevilla Spain 41010
    128 Regeneron Investigational Site Malmo Skane Sweden 211 52
    129 Regeneron Investigational Site Boras Sweden 50630
    130 Regeneron Investigational Site Goteburg Sweden 413 45
    131 Regeneron Investigational Site Helsingborg Sweden 25220
    132 Regeneron Investigational Site Linkoping Sweden 587 58
    133 Regeneron Investigational Site Lund Sweden 222 22
    134 Regeneron Investigational Site Uppsala Sweden 75237
    135 Regeneron Investigational Site Vällingby Sweden 16268
    136 Regeneron Investigational Site Cherkasy Ukraine 18009
    137 Regeneron Investigational Site #3 Kyiv Ukraine 02002
    138 Regeneron Investigational Site #1 Kyiv Ukraine 03037
    139 Regeneron Investigational Site #2 Kyiv Ukraine 03049
    140 Regeneron Investigational Site Lviv Ukraine 79495
    141 Regeneron Investigational Site Birmingham United Kingdom B15 2SQ
    142 Regeneron Investigational Site Chorley United Kingdom PR7 7NA
    143 Regeneron Investigational Site Glasgow United Kingdom G20 0SP
    144 Regeneron Investigational Site Hexham United Kingdom NE46 1QJ
    145 Regeneron Investigational Site Liverpool United Kingdom L22 0LG
    146 Regeneron Investigational Site Manchester United Kingdom M15 6SE
    147 Regeneron Investigational Site Middlesex United Kingdom HA6 2RN
    148 Regeneron Investigational Site Reading United Kingdom RG2 0TG
    149 Regeneron Investigational Site Romford United Kingdom RM1 3PJ
    150 Regeneron Investigational Site Sidcup United Kingdom DA14 6LT

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals
    • Teva Pharmaceutical Industries, Ltd.

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02683239
    Other Study ID Numbers:
    • R475-PN-1523
    • 2015-003783-36
    First Posted:
    Feb 17, 2016
    Last Update Posted:
    Dec 6, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Fasinumab

    Study Results

    No Results Posted as of Dec 6, 2021