Clinical trial NCT03161093: 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
Official title: A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Teva Pharmaceutical Industries, Ltd.
First posted: 2017-05-19
Enrollment: 3307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to 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:

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
10. 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


Eligibility criteria: Inclusion Criteria include, but are not limited to, the following:

Year 1:

1. Male and female patients, at least 18 years of age, at screening
2. 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
3. Moderate to severe pain in the index joint defined at both the screening and randomization visits
4. 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)
5. A history of at least 12 weeks of analgesics use for pain due to OA of the knee or hip, as defined by:

   1. Inadequate pain relief from acetaminophen/paracetamol AND
   2. 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
6. Currently using a stable dose of NSAID.
7. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment
8. Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period
9. 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
10. Willing to maintain current activity and exercise levels throughout the study
11. 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
12. 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.

1. Completed the treatment period of Year 1
2. Did not permanently discontinue study drug during Year 1
3. Received no less than 10 of the 13 planned doses of SC study drug during the treatment period of Year 1
4. Provide informed consent for Year 2
5. Willing to continue to maintain current activity and exercise levels throughout Year 2

Exclusion Criteria include, but are not limited to, the following:

1. Non-compliance with the Numeric Rating Scale (NRS) recording during the pre-randomization period
2. 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
3. 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
4. Trauma to the index joint within 3 months prior to the screening visit
5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
6. Patient is not a candidate for MRI
7. 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
8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
9. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
10. History of naproxen intolerance, or existence of a medical condition that is high risk for naproxen-associated complications
11. Resting heart rate of \<50 beats per minute (bpm) or \>100 bpm at the screening or randomization visits
12. 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
13. History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits
14. History of poorly controlled hypertension
15. 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
16. Exposure to an anti-Nerve growth factor (NGF) antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies

Primary outcomes:
measure: Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 16
measure: Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 16
measure: Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 16
measure: Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 16
measure: Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen
timeFrame: Baseline to Week 16
measure: Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo
timeFrame: Baseline to Week 44
measure: Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
timeFrame: Baseline to Week 16
measure: Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
timeFrame: Week 16
measure: Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
timeFrame: Baseline to Week 16
measure: Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 44
measure: Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen
timeFrame: Baseline to Week 44
measure: Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to average score across weeks 4, 8, 12 and 16
measure: Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to average score across weeks 36, 40 and 44
measure: Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
timeFrame: Baseline to Week 16
measure: Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 44
measure: Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
timeFrame: Baseline to Week 44
measure: Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to average score across weeks 4, 8, 12 and 16
measure: Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to average score across weeks 36, 40 and 44
measure: Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 16
measure: Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen
timeFrame: Baseline to Week 16
measure: Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo
timeFrame: Baseline to Week 44
measure: Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
timeFrame: Baseline to Week 16
measure: Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 44
measure: Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to average score across weeks 4, 8, 12 and 16
measure: Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to average score across weeks 36, 40 and 44
measure: Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
timeFrame: Baseline to Week 16
measure: Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
timeFrame: Baseline to Week 44
measure: Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to average score across weeks 4, 8, 12 and 16
measure: Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
timeFrame: Baseline to Week 16
measure: Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
timeFrame: Baseline to average score across weeks 36, 40 and 44
measure: Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1
timeFrame: Baseline to Week 52
measure: Number of Participants With AA (as Confirmed by Adjudication) - Year 2
timeFrame: First dose of study drug in Year 2 through week 104E
measure: Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2
timeFrame: Day 1 through week 104E (Extension)
measure: Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1
timeFrame: Baseline to Week 52
measure: Number of Participants With DA (as Confirmed by Adjudication) - Year 2
timeFrame: First dose of study drug in Year 2 through week 104E
measure: Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2
timeFrame: Day 1 through week 104E
measure: Number of Treatment Emergent Adverse Events (TEAEs) - Year 1
timeFrame: Baseline to Week 52
measure: Number of TEAEs - Year 2
timeFrame: First dose of study drug in Year 2 through week 104E
measure: Number of TEAEs - Year 1 and Year 2
timeFrame: Day 1 through week 104E
measure: Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1
timeFrame: Baseline to Week 52
measure: Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2
timeFrame: First dose of study drug in Year 2 through week 104E
measure: Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2
timeFrame: Day 1 through week 104E
measure: Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1
timeFrame: Baseline to Week 52
measure: Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2
timeFrame: First dose of study drug in Year 2 through week 104E
measure: Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2
timeFrame: Day 1 through week 104E
measure: Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1
timeFrame: Baseline to Week 52
measure: Number of Participants With Any Type of All-Cause JR in Year 2
timeFrame: First dose of study drug in Year 2 through week 104E
measure: Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2
timeFrame: Day 1 through week 104E
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Research Center
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: La Mesa
country: United States
facility: BioSolutions Clinical Research
state: California
city: Los Angeles
country: United States
facility: Pacific Arthritis Care Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Marcos
country: United States
facility: Artemis Clinical Research
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Golden
country: United States
facility: Panorama Orthopedics & Spine Center
state: Colorado
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Jewett Orthopaedic Clinic
state: Florida
city: Venice
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Medex Healthcare Research, Inc.
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Cumberland
country: United States
facility: Klein & Associates, MD PA
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates, MD, PA
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc.
state: New Mexico
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: New York
country: United States
facility: Medex Healthcare Research
state: New York
city: Orchard Park
country: United States
facility: Buffalo Rheumatology and Medicine, PLLC
state: New York
city: Orchard Park
country: United States
facility: Orchard Park Family Practice
state: New York
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Hickory
country: United States
facility: Hickory Family Practice Associates
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Oklahoma City
country: United States
facility: Hillcrest Clinical Research
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston, LLC
state: South Carolina
city: Franklin
country: United States
facility: Clinical Research Solutions
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Cypress
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC
state: Texas
city: Chesapeake
country: United States
facility: Center for Arthritis and Rheumatic Diseases
state: Virginia
city: Beckley
country: United States
facility: Rheumatology & Pulmonary Clinic
state: West Virginia
city: Vejle
country: Denmark
facility: CCBR Vejle
city: Leipzig
country: Germany
facility: Synexus Clinical Research GmbH
state: Sachsen
city: Berlin
country: Germany
facility: Synexus Clinical Research GmbH
city: Bochum
country: Germany
facility: Synexus Clinical Research GmbH
city: Frankfurt
country: Germany
facility: Synexus Clinical Research GmbH
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft
city: Debrecen
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Gyula
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Hatvan
country: Hungary
facility: BKS Research Kft.
city: Hévíz
country: Hungary
facility: Hevizgyogyfurdo es Szent Andraes ReumaKorhaz
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Josa Andras Oktatokorhaza Klinikai Kutatasi Osztaly
city: Zalaegerszeg
country: Hungary
facility: Synexus Magyarorszag Egeszsegugyi Kft.
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Kaunas
country: Lithuania
facility: Saules Seimos Medicinos Centras, Jsc
city: Panevėžys
country: Lithuania
facility: Republican Panevezys Hospital
city: Vilnius
country: Lithuania
facility: Center Outpation Clinic, Public Institution
city: Wrocław
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
state: Dolnoslaskie
city: Łódź
country: Poland
facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02 - SOMED - Lodzkie Centrum Osteoporozy
state: Lodzkie
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
state: Malopolskie
city: Grodzisk Mazowiecki
country: Poland
facility: MCBK Sc lwona Czajkowska Monika Barney
state: Mazowieckie
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
state: Mazowieckie
city: Warszawa
country: Poland
facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o.
state: Mazowieckie
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
state: Pomorskie
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
state: Pomorskie
city: Poznań
country: Poland
facility: Synexus Polska Sp. z o.o Oddzial w Poznaniu
state: Wielkopolskie
city: Białystok
country: Poland
facility: ClinicMed Daniluk, Nowak Sp.j.
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Kraków
country: Poland
facility: Malopolskie Centrum Kliniczne
city: Skierniewice
country: Poland
facility: CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
city: Zgierz
country: Poland
facility: Etg Zgierz
city: Bucharest
country: Romania
facility: Clinica Medicala Synexus Ltd.
city: Bucharest
country: Romania
facility: SC Policlinica CCBR SRL
city: Kazan
country: Russian Federation
facility: SBEIHPE "Kazan State Medical University" of MHSD of Russia
state: Tatarstan Republic
city: Novosibirsk
country: Russian Federation
facility: CDCR "Healthy Joints" L.L.C.
city: Saint Petersburg
country: Russian Federation
facility: City Out-Patient Clinic #109
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital n.a.V.D.Seredavin
city: Yaroslavl
country: Russian Federation
facility: State Autonomous Healthcare Institution of Yaroslavl Oblast "Clinical Hospital #3"
city: Parow
country: South Africa
facility: Tread Research-Tygerberg Hospital
state: Cape Town
city: Welkom
country: South Africa
facility: Welkom Clinical trial Centre
state: Free State
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: University of Pretoria
state: Gauteng
city: Pretoria
country: South Africa
facility: Global Clinical Trials
state: Gauteng
city: Pretoria
country: South Africa
facility: Synexus SA Stanza Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Synexus Watermeyer Clinical Research Centre
state: Gauteng
city: Roodepoort
country: South Africa
facility: Roodepoort Medicross Clinical Research Centre
state: Gauteng
city: Soweto
country: South Africa
facility: Soweto Clinical Trials Centre (CTC)
state: Johannesburg
city: Durban
country: South Africa
facility: Synapta Clinical Research Center
state: Kwa-Zulu Natal
city: Umkomaas
country: South Africa
facility: Aliwal Shoal Medical Centre
state: Kwa-Zulu Natal
city: Durban
country: South Africa
facility: Enhancing Care
state: KwaZulu-Natal
city: Middelburg
country: South Africa
facility: Mzansi Ethical Research Centre Middleburg
state: Mpumalanga
city: Kraaifontein
country: South Africa
facility: Langeberg Medicross Medical Centre
state: Western Cape
city: Paarl
country: South Africa
facility: Paarl Research Centre
state: Western Cape
city: Somerset West
country: South Africa
facility: Synexus Helderberg Clinical Trial Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: TASK Applied Science
city: Cape Town
country: South Africa
facility: Mzansi Ethical Research Centre Cape Town
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research
city: Leganés
country: Spain
facility: CETA Leganes
state: Madrid
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Madrid
country: Spain
facility: MeDiNova Investigacion y Desarrollo
city: Santiago De Compostela
country: Spain
facility: Centro De Investigacion Clinica En Enfermedades Cronicas - Cicec
city: Sevilla
country: Spain
facility: Clínica Nuevas Tecnologias en Diabetes y Endocrinologia (NTDE)
city: Sevilla
country: Spain
facility: Hospital Quiron Salud Infanta Luisa
city: Cherkasy
country: Ukraine
facility: Municipal Establishment "Cherkasy Regional Hospital of Cherkasy Oblast Council"
city: Kharkiv
country: Ukraine
facility: Kharkiv City Multispecialty Hospital #18
city: Kyiv
country: Ukraine
facility: Medical center of Private High Educational Institute Institute of General Practice-Family Medicine
city: Kyiv
country: Ukraine
facility: Subsidiary Company "Medical Research and Practice Center Medbud of the Public Joint Stock "Holding Company "Kyivmiskbud"
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital No.2 of branch "Health Center " of the PJSC "Ukrainian Railway"
city: Lviv
country: Ukraine
facility: Lviv Regional Hospital for veterans of the war and former political prisoners
city: Reading
country: United Kingdom
facility: Synexus Thames Valley Clinical Research Centre
state: Berkshire
city: Glasgow
country: United Kingdom
facility: Synexus Scotland Clinical Research Centre
state: Lanarkshire
city: Chorley
country: United Kingdom
facility: Synexus Lancashire Clinical Research Centre
state: Lancashire
city: Northwood
country: United Kingdom
facility: MediNova North London Dedicated Research Centre, Mount Vernon Hospital
state: Middlesex
city: Hexham
country: United Kingdom
facility: Synexus North East Clinical Research Centre - Hexham General Hospital
state: Northumberland
city: Birmingham
country: United Kingdom
facility: Synexus Midlands Clinical Research Centre
state: West Midlands
city: Cardiff
country: United Kingdom
facility: Synexus Wales Clinical Research Centre
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside Clinical Research Centre
city: Manchester
country: United Kingdom
facility: Synexus Manchester Clinical Research Centre-Manchester Science Park
city: Romford
country: United Kingdom
facility: Medinova Research East London Clinical Studies Centre
city: Shipley
country: United Kingdom
facility: MeDiNova Research Yorkshire Clinical Studies Centre
city: Sidcup
country: United Kingdom
facility: MediNova South London Dedicated Research Centre
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: