FACT OA1: 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
Study Details
Study Description
Brief Summary
The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.
The secondary objectives of the study are:
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To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
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To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
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To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
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To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip
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To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip
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To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
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To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
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To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
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To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
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To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Fasinumab dosing regimen 1 Fasinumab Subcutaneous (SC) dosing regimen 1 and naproxen-matching placebo oral |
Drug: Fasinumab
Solution for injection in pre-filled syringe
Other Names:
Drug: Naproxen-matching placebo
Capsule
|
Experimental: Fasinumab dosing regimen 2 Fasinumab SC dosing regimen 2 and naproxen-matching placebo oral |
Drug: Fasinumab
Solution for injection in pre-filled syringe
Other Names:
Drug: Naproxen-matching placebo
Capsule
|
Experimental: Fasinumab-matching placebo and naproxen
|
Drug: Naproxen
Pharmaceutical form: Capsule
Drug: Fasinumab-matching placebo
Solution for injection in pre-filled syringe
|
Experimental: Fasinumab-matching placebo and naproxen-matching placebo
|
Drug: Fasinumab-matching placebo
Solution for injection in pre-filled syringe
Drug: Naproxen-matching placebo
Capsule
|
Outcome Measures
Primary Outcome Measures
- Change in the WOMAC pain subscale scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to Week 16]
- Change in the WOMAC physical function subscale scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to Week 16]
Secondary Outcome Measures
- Change in the Patient Global Assessment (PGA) scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to Week 16]
- Percentage of patients treated with fasinumab, compared with that of patients treated with placebo, who had a response at week 16, with response defined as an improvement by ≥30% in the WOMAC pain subscale scores [Baseline to Week 16]
- Change in WOMAC pain subscale scores from baseline to week 16 in patients treated with fasinumab, compared with that of patients treated with naproxen [Baseline to Week 16]
- Change in WOMAC physical function subscale scores from baseline to week 16 in patients treated with fasinumab, compared with that of patients treated with naproxen [Baseline to Week 16]
- Change in WOMAC pain subscale scores from baseline to week 44 in patients treated with fasinumab, compared with that of patients treated with placebo [Baseline to Week 44]
- Change in WOMAC physical function subscale scores from baseline to week 44 in patients treated with fasinumab, compared with that of patients treated with placebo [Baseline to Week 44]
- Change in the PGA scores from baseline to week 44 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to Week 44]
- Change in the PGA scores from baseline to week 16 in patients treated with fasinumab compared with that of patients treated with naproxen [Baseline to Week 16]
- Change in WOMAC pain subscale scores from baseline to week 44 in patients treated with fasinumab, compared with that of patients treated with naproxen [Baseline to Week 44]
- Change in WOMAC physical function subscale scores from baseline to week 44 in patients treated with fasinumab, compared with that of patients treated with naproxen [Baseline to Week 44]
- Percentage of patients treated with fasinumab, compared with that of patients treated with naproxen, who had a response at week 16, with response defined as an improvement by ≥30% in the WOMAC pain subscale scores [Week 16]
- Change in WOMAC pain subscale scores from baseline to the average score across weeks 4, 8, 12 and 16, in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to average score across weeks 4, 8, 12 and 16]
- Change in WOMAC physical function subscale scores from baseline to the average score across weeks 4, 8, 12 and 16, in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to average score across weeks 4, 8, 12 and 16]
- Change in WOMAC pain subscale scores from baseline to the average score across weeks 36, 40 and 44 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to average score across weeks 36, 40 and 44]
- Change in WOMAC physical function subscale scores from baseline to the average score across weeks 36, 40 and 44 in patients treated with fasinumab compared with that of patients treated with placebo [Baseline to average score across weeks 36, 40 and 44]
- Incidence of Adjudicated Arthropathy (AA) (as confirmed by adjudication) [Baseline to Week 52]
Year 1
- Incidence of AA (as confirmed by adjudication) [Day 1 through week 104E (Extension)]
Year 1 and Year 2
- Incidence of AA (as confirmed by adjudication) [First dose of study drug in Year 2 through week 104E]
Year 2
- Incidence of Destructive Arthropathy (DA) (as confirmed by adjudication) [Baseline to Week 52]
Year 1
- Incidence of DA (as confirmed by adjudication) [Day 1 through week 104E]
Year 1 and Year 2
- Incidence of DA (as confirmed by adjudication) [First dose of study drug in Year 2 through week 104E]
Year 2
- Incidence of Treatment Emergent Adverse Events (TEAEs) [Baseline to Week 52]
Year 1
- Incidence of TEAEs [Day 1 through week 104E]
Year 1 and Year 2
- Incidence of TEAEs [First dose of study drug in Year 2 through week 104E]
Year 2
- Incidence of sympathetic nervous system dysfunction [Baseline to Week 52]
Year 1
- Incidence of sympathetic nervous system dysfunction [Day 1 through week 104E]
Year 1 and Year 2
- Incidence of sympathetic nervous system dysfunction [First dose of study drug in Year 2 through week 104E]
Year 2
- Incidence of Peripheral sensory AEs that require a neurology or other specialty consultation [Baseline to Week 52]
Year 1
- Incidence of Peripheral sensory AEs that require a neurology or other specialty consultation [Day 1 through week 104E]
Year 1 and Year 2
- Incidence of Peripheral sensory AEs that require a neurology or other specialty consultation [First dose of study drug in Year 2 through week 104E]
Year 2
- Incidence of all-cause joint replacement (JR) [Baseline to Week 52]
Year 1
- Incidence of all-cause JR [Day 1 through week 104E]
Year 1 and Year 2
- Incidence of all-cause JR [First dose of study drug in Year 2 through week 104E]
Year 2
- Incidence of JRs at the telephone survey [52 weeks after last dose of study drug (week 100)]
Patients who only completed Year 1
- Incidence of JRs at the telephone survey [52 weeks after last dose of study drug (week 152E)]
Patients who completed Year 2
Eligibility Criteria
Criteria
Inclusion Criteria include, but are not limited to, the following:
Year 1:
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Male and female patients, at least 18 years of age, at screening
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A 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
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Moderate to severe pain in the index joint defined at both the screening and randomization visits
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Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol) to be taken as needed with a maximum daily dose of 2500 mg (countries where 500 mg strength tablets/capsules are available) or 2600 mg (countries where 325 mg strength tablets/capsules are available)
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A history of at least 12 weeks of analgesics use for pain due to OA of the knee or hip, as defined by:
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Inadequate pain relief from acetaminophen/paracetamol AND
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Intolerance to or inadequate pain relief from opioid or tramadol therapy, unwillingness to take opioid or tramadol therapy for a medically acceptable reason, or lack of access to an opioid or to tramadol
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Currently using a stable dose of NSAID.
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Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment
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Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period
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Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere prior to and during the study period to be shared with the investigator
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Willing to maintain current activity and exercise levels throughout the study
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Willing and able to comply with clinic visits and study-related procedures and willing to provide follow-up information related to any JR surgery that occurs within the period of time covered by their intended participation in the study
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Able to understand and complete study-related questionnaires
Year 2:
Note: Any Year 1 patient attending their week 52 visit on or after 26 March 2020 will no longer have the option to enroll into Year 2.
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Completed the treatment period of Year 1
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Did not permanently discontinue study drug during Year 1
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Received no less than 10 of the 13 planned doses of SC study drug during the treatment period of Year 1
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Provide informed consent for Year 2
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Willing to continue to maintain current activity and exercise levels throughout Year 2
Exclusion Criteria include, but are not limited to, the following:
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Non-compliance with the Numeric Rating Scale (NRS) recording during the pre-randomization period
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History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
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History or presence on imaging of arthropathy, neuropathic joint arthropathy, hip or knee dislocation, extensive subchondral cysts, significant bone collapse or bone loss, or pathologic fractures
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Trauma to the index joint within 3 months prior to the screening visit
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Signs or symptoms of carpal tunnel syndrome within 6 months of screening
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Patient is not a candidate for MRI
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Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
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History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
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History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
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History of naproxen intolerance, or existence of a medical condition that is high risk for naproxen-associated complications
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Resting heart rate of <50 beats per minute (bpm) or >100 bpm at the screening or randomization visits
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History or presence of 2nd or 3rd degree heart block, 1st degree heart block with abnormal Complex of Q, R, and S waves on an electrocardiogram (QRS) complex, or bifascicular block by ECG assessment at the screening visit
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History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits
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History of poorly controlled hypertension
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Use of systemic corticosteroid within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
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Exposure to an anti-Nerve growth factor (NGF) antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Arizona Arthritis & Rheumatology Research, PLLC | Mesa | Arizona | United States | 85210 |
2 | Arizona Research Center | Phoenix | Arizona | United States | 85053 |
3 | Tucson Orthopaedic Research Center | Tucson | Arizona | United States | 85712 |
4 | Baptist Health Center for Clinical Research | Little Rock | Arkansas | United States | 72205 |
5 | Medvin Clinical Research | Covina | California | United States | 91722 |
6 | TriWest Research Associates, LLC | El Cajon | California | United States | 92020 |
7 | BioSolutions Clinical Research | La Mesa | California | United States | 91942 |
8 | Pacific Arthritis Care Center | Los Angeles | California | United States | 90045 |
9 | Artemis Institute for Clinical Research | San Diego | California | United States | 92103 |
10 | Artemis Clinical Research | San Marcos | California | United States | 92078 |
11 | Lynn Institute of Denver | Aurora | Colorado | United States | 80012 |
12 | Lynn Institute of the Rockies | Colorado Springs | Colorado | United States | 80920 |
13 | Panorama Orthopedics & Spine Center | Golden | Colorado | United States | 80401 |
14 | Arthritis and Rheumatic Disease Specialties | Aventura | Florida | United States | 33180 |
15 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
16 | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | United States | 32256 |
17 | Sensible Healthcare | Ocoee | Florida | United States | 34761 |
18 | Clinical Neuroscience Solutions, Inc. | Orlando | Florida | United States | 32801 |
19 | Jewett Orthopaedic Clinic | Orlando | Florida | United States | 32825 |
20 | Lovelace Scientific Resources | Venice | Florida | United States | 34292 |
21 | Meridian Clinical Research | Savannah | Georgia | United States | 31406 |
22 | Advanced Clinical Research | Meridian | Idaho | United States | 83642 |
23 | Medex Healthcare Research, Inc. | Chicago | Illinois | United States | 60602 |
24 | Northwestern University | Chicago | Illinois | United States | 60611 |
25 | Healthcare Research Network II, LLC | Flossmoor | Illinois | United States | 60422 |
26 | Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | United States | 50265 |
27 | Klein & Associates, MD PA | Cumberland | Maryland | United States | 21502 |
28 | Klein & Associates, MD, PA | Hagerstown | Maryland | United States | 21740 |
29 | The Center for Rheumatology and Bone Research | Wheaton | Maryland | United States | 20902 |
30 | Clinical Pharmacology Study Group | Worcester | Massachusetts | United States | 01605 |
31 | The Center for Pharmaceutical Research | Kansas City | Missouri | United States | 64114 |
32 | Medex Healthcare Research, Inc. | Saint Louis | Missouri | United States | 63117 |
33 | Sundance Clinical Research, LLC | Saint Louis | Missouri | United States | 63141 |
34 | Physician Research Collaboration, LLC | Lincoln | Nebraska | United States | 68516 |
35 | Lovelace Scientific Resources, Inc. | Albuquerque | New Mexico | United States | 87108 |
36 | United Medical Associates | Binghamton | New York | United States | 13901 |
37 | Regional Clinical Research, Inc. | Endwell | New York | United States | 13760 |
38 | Medex Healthcare Research | New York | New York | United States | 10036 |
39 | Buffalo Rheumatology and Medicine, PLLC | Orchard Park | New York | United States | 14127 |
40 | Orchard Park Family Practice | Orchard Park | New York | United States | 14127 |
41 | PMG Research of Raleigh, LLC d/b/a PMG Research of Cary | Cary | North Carolina | United States | 27518 |
42 | DJL Clinical Research, PLLC | Charlotte | North Carolina | United States | 28210 |
43 | Hickory Family Practice Associates | Hickory | North Carolina | United States | 28601 |
44 | Peters Medical Research LLC | High Point | North Carolina | United States | 27262 |
45 | PMG Research of Salisbury, LLC | Salisbury | North Carolina | United States | 28144 |
46 | PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | United States | 27103 |
47 | Sterling Research Group, Ltd. | Cincinnati | Ohio | United States | 45219 |
48 | Hillcrest Clinical Research | Oklahoma City | Oklahoma | United States | 73119 |
49 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
50 | Low Country Rheumatology, PA | Charleston | South Carolina | United States | 29406 |
51 | PMG Research of Charleston, LLC | Mount Pleasant | South Carolina | United States | 29464 |
52 | Clinical Research Solutions | Franklin | Tennessee | United States | 37067 |
53 | PMG Research of Knoxville | Knoxville | Tennessee | United States | 37912 |
54 | Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | United States | 38119 |
55 | Pioneer Research Solutions, Inc. | Cypress | Texas | United States | 77429 |
56 | Southwest Rheumatology Research, LLC | Mesquite | Texas | United States | 75150 |
57 | Center for Arthritis and Rheumatic Diseases | Chesapeake | Virginia | United States | 23320 |
58 | Rheumatology & Pulmonary Clinic | Beckley | West Virginia | United States | 25801 |
59 | CCBR Vejle | Vejle | Denmark | DK 7100 | |
60 | Synexus Clinical Research GmbH | Leipzig | Sachsen | Germany | 04103 |
61 | Synexus Clinical Research GmbH | Berlin | Germany | 12627 | |
62 | Synexus Clinical Research GmbH | Bochum | Germany | 44787 | |
63 | Synexus Clinical Research GmbH | Frankfurt | Germany | 60313 | |
64 | Qualiclinic Kft. | Budapest | Hungary | 1036 | |
65 | Synexus Magyarorszag Kft | Budapest | Hungary | 1036 | |
66 | Synexus Magyarorszag Kft. | Debrecen | Hungary | 4025 | |
67 | Synexus Magyarorszag Kft. | Gyula | Hungary | 5700 | |
68 | BKS Research Kft. | Hatvan | Hungary | 3000 | |
69 | Hevizgyogyfurdo es Szent Andraes ReumaKorhaz | Hévíz | Hungary | 8380 | |
70 | Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Josa Andras Oktatokorhaza Klinikai Kutatasi Osztaly | Nyíregyháza | Hungary | 4400 | |
71 | Synexus Magyarorszag Egeszsegugyi Kft. | Zalaegerszeg | Hungary | 8900 | |
72 | Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | Lithuania | LT35144 | |
73 | Saules Seimos Medicinos Centras, Jsc | Kaunas | Lithuania | LT50009 | |
74 | Republican Panevezys Hospital | Panevėžys | Lithuania | LT01117 | |
75 | Center Outpation Clinic, Public Institution | Vilnius | Lithuania | LT01117 | |
76 | Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wrocław | Dolnoslaskie | Poland | 59-381 |
77 | Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02 - SOMED - Lodzkie Centrum Osteoporozy | Łódź | Lodzkie | Poland | 90-368 |
78 | Krakowskie Centrum Medyczne Sp. z o.o. | Kraków | Malopolskie | Poland | 31-501 |
79 | MCBK Sc lwona Czajkowska Monika Barney | Grodzisk Mazowiecki | Mazowieckie | Poland | 05-825 |
80 | Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warszawa | Mazowieckie | Poland | 01-192 |
81 | Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. | Warszawa | Mazowieckie | Poland | 04-730 |
82 | Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdynia | Pomorskie | Poland | 81-537 |
83 | Synexus Polska Sp. z o.o. Oddzial w Gdyni | Gdynia | Pomorskie | Poland | 81-537 |
84 | Synexus Polska Sp. z o.o Oddzial w Poznaniu | Poznań | Wielkopolskie | Poland | 60-702 |
85 | ClinicMed Daniluk, Nowak Sp.j. | Białystok | Poland | 15-879 | |
86 | Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice | Poland | 40-040 | |
87 | Malopolskie Centrum Kliniczne | Kraków | Poland | 30-149 | |
88 | CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa | Skierniewice | Poland | 96-100 | |
89 | Etg Zgierz | Zgierz | Poland | 95-100 | |
90 | Clinica Medicala Synexus Ltd. | Bucharest | Romania | 021611 | |
91 | SC Policlinica CCBR SRL | Bucharest | Romania | 030463 | |
92 | "SBEIHPE ""Kazan State Medical University"" of MHSD of Russia" | Kazan | Tatarstan Republic | Russian Federation | 420012 |
93 | "CDCR ""Healthy Joints"" L.L.C." | Novosibirsk | Russian Federation | 630099 | |
94 | City Out-Patient Clinic #109 | Saint Petersburg | Russian Federation | 192263 | |
95 | Samara Regional Clinical Hospital n.a.V.D.Seredavin | Samara | Russian Federation | 443095 | |
96 | "State Autonomous Healthcare Institution of Yaroslavl Oblast ""Clinical Hospital #3""" | Yaroslavl | Russian Federation | 150007 | |
97 | Tread Research-Tygerberg Hospital | Parow | Cape Town | South Africa | 7500 |
98 | Welkom Clinical trial Centre | Welkom | Free State | South Africa | 9460 |
99 | Wits Clinical Research | Johannesburg | Gauteng | South Africa | 2013 |
100 | University of Pretoria | Pretoria | Gauteng | South Africa | 0002 |
101 | Global Clinical Trials | Pretoria | Gauteng | South Africa | 0083 |
102 | Synexus SA Stanza Clinical Research Centre | Pretoria | Gauteng | South Africa | 0122 |
103 | Synexus Watermeyer Clinical Research Centre | Pretoria | Gauteng | South Africa | 0184 |
104 | Roodepoort Medicross Clinical Research Centre | Roodepoort | Gauteng | South Africa | 1724 |
105 | Soweto Clinical Trials Centre (CTC) | Soweto | Johannesburg | South Africa | 1818 |
106 | Synapta Clinical Research Center | Durban | Kwa-Zulu Natal | South Africa | 4001 |
107 | Aliwal Shoal Medical Centre | Umkomaas | Kwa-Zulu Natal | South Africa | 4170 |
108 | Enhancing Care | Durban | KwaZulu-Natal | South Africa | 4091 |
109 | Mzansi Ethical Research Centre Middleburg | Middelburg | Mpumalanga | South Africa | 1055 |
110 | Langeberg Medicross Medical Centre | Kraaifontein | Western Cape | South Africa | 7570 |
111 | Paarl Research Centre | Paarl | Western Cape | South Africa | 7646 |
112 | Synexus Helderberg Clinical Trial Centre | Somerset West | Western Cape | South Africa | 7130 |
113 | TASK Applied Science | Cape Town | South Africa | 7530 | |
114 | Mzansi Ethical Research Centre Cape Town | Cape Town | South Africa | 7764 | |
115 | Newtown Clinical Research | Johannesburg | South Africa | 2113 | |
116 | CETA Leganes | Leganés | Madrid | Spain | 28915 |
117 | Complejo Hospitalario Universitario A Coruna | A Coruña | Spain | 15006 | |
118 | MeDiNova Investigacion y Desarrollo | Madrid | Spain | 28100 | |
119 | Centro De Investigacion Clinica En Enfermedades Cronicas - Cicec | Santiago De Compostela | Spain | 15705 | |
120 | Clínica Nuevas Tecnologias en Diabetes y Endocrinologia (NTDE) | Sevilla | Spain | 41003 | |
121 | Hospital Quiron Salud Infanta Luisa | Sevilla | Spain | 41010 | |
122 | "Municipal Establishment ""Cherkasy Regional Hospital of Cherkasy Oblast Council""" | Cherkasy | Ukraine | 18009 | |
123 | Kharkiv City Multispecialty Hospital #18 | Kharkiv | Ukraine | 61029 | |
124 | Medical center of Private High Educational Institute Institute of General Practice-Family Medicine | Kyiv | Ukraine | 02002 | |
125 | "Subsidiary Company ""Medical Research and Practice Center Medbud of the Public Joint Stock ""Holding Company ""Kyivmiskbud""" | Kyiv | Ukraine | 03037 | |
126 | "Kyiv Railway Clinical Hospital No.2 of branch ""Health Center "" of the PJSC ""Ukrainian Railway""" | Kyiv | Ukraine | 03049 | |
127 | Lviv Regional Hospital for veterans of the war and former political prisoners | Lviv | Ukraine | 79495 | |
128 | Synexus Thames Valley Clinical Research Centre | Reading | Berkshire | United Kingdom | RG2 0TG |
129 | Synexus Scotland Clinical Research Centre | Glasgow | Lanarkshire | United Kingdom | G20 0SP |
130 | Synexus Lancashire Clinical Research Centre | Chorley | Lancashire | United Kingdom | PR7 7NA |
131 | MediNova North London Dedicated Research Centre, Mount Vernon Hospital | Northwood | Middlesex | United Kingdom | HA6 2RN |
132 | Synexus North East Clinical Research Centre - Hexham General Hospital | Hexham | Northumberland | United Kingdom | NE46 1QJ |
133 | Synexus Midlands Clinical Research Centre | Birmingham | West Midlands | United Kingdom | B15 2SQ |
134 | Synexus Wales Clinical Research Centre | Cardiff | United Kingdom | CF15 9SS | |
135 | Synexus Merseyside Clinical Research Centre | Liverpool | United Kingdom | L22 0LG | |
136 | Synexus Manchester Clinical Research Centre-Manchester Science Park | Manchester | United Kingdom | M15 6SX | |
137 | Medinova Research East London Clinical Studies Centre | Romford | United Kingdom | RM1 3PJ | |
138 | MeDiNova Research Yorkshire Clinical Studies Centre | Shipley | United Kingdom | BD18 3SA | |
139 | MediNova South London Dedicated Research Centre | 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.- R475-OA-1611
- 2016-005020-29