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
- Conditions
- Osteoarthritis, KneeOsteoarthritis, Hip
- Interventions
- Registration Number
- NCT03161093
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3307
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fasinumab dosing regimen 1 Fasinumab Fasinumab Subcutaneous (SC) dosing regimen 1 and naproxen-matching placebo oral Fasinumab-matching placebo and naproxen-matching placebo Fasinumab-matching placebo - Fasinumab dosing regimen 1 Naproxen-matching placebo Fasinumab Subcutaneous (SC) dosing regimen 1 and naproxen-matching placebo oral Fasinumab-matching placebo and naproxen-matching placebo Naproxen-matching placebo - Fasinumab dosing regimen 2 Naproxen-matching placebo Fasinumab SC dosing regimen 2 and naproxen-matching placebo oral Fasinumab-matching placebo and naproxen Fasinumab-matching placebo - Fasinumab-matching placebo and naproxen Naproxen - Fasinumab dosing regimen 2 Fasinumab Fasinumab SC dosing regimen 2 and naproxen-matching placebo oral
- Primary Outcome Measures
Name Time Method 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 Baseline to Week 16 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.
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 Baseline to Week 16 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.
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 Baseline to Week 16 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.
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 Baseline to Week 16 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1 Baseline to Week 52 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 Baseline to Week 16 The Patient Global Assessment of OA (PGA) 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).
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 Baseline to average score across weeks 36, 40 and 44 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.
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 Baseline to Week 44 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.
Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1 Baseline to Week 52 Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2 Day 1 through week 104E Number of TEAEs - Year 1 and Year 2 Day 1 through week 104E 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 Baseline to average score across weeks 4, 8, 12 and 16 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.
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 Baseline to Week 16 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.
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 Baseline to Week 16 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.
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 Baseline to Week 16 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.
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 Baseline to Week 16 The Patient Global Assessment of OA (PGA) 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).
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 Baseline to Week 44 The Patient Global Assessment of OA (PGA) 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).
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 Baseline to Week 16 The Patient Global Assessment of OA (PGA) 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).
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 Baseline to Week 16 The Patient Global Assessment of OA (PGA) 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).
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 Baseline to Week 16 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.
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2 Day 1 through week 104E 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 Baseline to Week 16 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.
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 Week 16 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.
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 Baseline to Week 44 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.
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 Baseline to Week 44 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.
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 Baseline to average score across weeks 36, 40 and 44 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.
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 Baseline to Week 44 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.
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 Baseline to Week 16 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.
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 Baseline to Week 44 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.
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 Baseline to average score across weeks 4, 8, 12 and 16 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.
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 Baseline to Week 44 The Patient Global Assessment of OA (PGA) 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).
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 Baseline to average score across weeks 4, 8, 12 and 16 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.
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 Baseline to average score across weeks 36, 40 and 44 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.
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 Baseline to Week 44 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.
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 Baseline to average score across weeks 36, 40 and 44 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.
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 Baseline to average score across weeks 4, 8, 12 and 16 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.
Number of Participants With DA (as Confirmed by Adjudication) - Year 2 First dose of study drug in Year 2 through week 104E Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 Baseline to Week 52 Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 Baseline to Week 52 Number of Participants With AA (as Confirmed by Adjudication) - Year 2 First dose of study drug in Year 2 through week 104E Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2 Day 1 through week 104E (Extension) Number of Treatment Emergent Adverse Events (TEAEs) - Year 1 Baseline to Week 52 Number of TEAEs - Year 2 First dose of study drug in Year 2 through week 104E Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2 First dose of study drug in Year 2 through week 104E Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2 Day 1 through week 104E Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1 Baseline to Week 52 Number of Participants With Any Type of All-Cause JR in Year 2 First dose of study drug in Year 2 through week 104E Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2 First dose of study drug in Year 2 through week 104E Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2 Day 1 through week 104E
Trial Locations
- Locations (132)
Pacific Arthritis Care Center
🇺🇸Los Angeles, California, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Panorama Orthopedics & Spine Center
🇺🇸Golden, Colorado, United States
Orchard Park Family Practice
🇺🇸Orchard Park, New York, United States
Synexus Clinical Research GmbH
🇩🇪Frankfurt, Germany
Synexus Polska Sp. z o.o. Oddzial w Warszawie
🇵🇱Warszawa, Mazowieckie, Poland
"SBEIHPE ""Kazan State Medical University"" of MHSD of Russia"
🇷🇺Kazan, Tatarstan Republic, Russian Federation
University of Pretoria
🇿🇦Pretoria, Gauteng, South Africa
Mzansi Ethical Research Centre Cape Town
🇿🇦Cape Town, South Africa
"Municipal Establishment ""Cherkasy Regional Hospital of Cherkasy Oblast Council"""
🇺🇦Cherkasy, Ukraine
Medical center of Private High Educational Institute Institute of General Practice-Family Medicine
🇺🇦Kyiv, Ukraine
"Subsidiary Company ""Medical Research and Practice Center Medbud of the Public Joint Stock ""Holding Company ""Kyivmiskbud"""
🇺🇦Kyiv, Ukraine
Synexus Scotland Clinical Research Centre
🇬🇧Glasgow, Lanarkshire, United Kingdom
Synexus Lancashire Clinical Research Centre
🇬🇧Chorley, Lancashire, United Kingdom
Synexus Merseyside Clinical Research Centre
🇬🇧Liverpool, United Kingdom
Synexus Midlands Clinical Research Centre
🇬🇧Birmingham, West Midlands, United Kingdom
Mzansi Ethical Research Centre Middleburg
🇿🇦Middelburg, Mpumalanga, South Africa
"CDCR ""Healthy Joints"" L.L.C."
🇷🇺Novosibirsk, Russian Federation
Tucson Orthopaedic Research Center
🇺🇸Tucson, Arizona, United States
Medvin Clinical Research
🇺🇸Covina, California, United States
TriWest Research Associates, LLC
🇺🇸El Cajon, California, United States
BioSolutions Clinical Research
🇺🇸La Mesa, California, United States
Artemis Clinical Research
🇺🇸San Marcos, California, United States
Arthritis and Rheumatic Disease Specialties
🇺🇸Aventura, Florida, United States
Meridian Clinical Research
🇺🇸Savannah, Georgia, United States
Advanced Clinical Research
🇺🇸Meridian, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Medex Healthcare Research, Inc.
🇺🇸Saint Louis, Missouri, United States
Klein & Associates, MD, PA
🇺🇸Hagerstown, Maryland, United States
Klein & Associates, MD PA
🇺🇸Cumberland, Maryland, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Medex Healthcare Research
🇺🇸New York, New York, United States
Lovelace Scientific Resources, Inc.
🇺🇸Albuquerque, New Mexico, United States
Buffalo Rheumatology and Medicine, PLLC
🇺🇸Orchard Park, New York, United States
Physician Research Collaboration, LLC
🇺🇸Lincoln, Nebraska, United States
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
Hickory Family Practice Associates
🇺🇸Hickory, North Carolina, United States
DJL Clinical Research, PLLC
🇺🇸Charlotte, North Carolina, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
🇺🇸Cary, North Carolina, United States
Peters Medical Research LLC
🇺🇸High Point, North Carolina, United States
PMG Research of Salisbury, LLC
🇺🇸Salisbury, North Carolina, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
PMG Research of Charleston, LLC
🇺🇸Mount Pleasant, South Carolina, United States
Pioneer Research Solutions, Inc.
🇺🇸Cypress, Texas, United States
Southwest Rheumatology Research, LLC
🇺🇸Mesquite, Texas, United States
Center for Arthritis and Rheumatic Diseases
🇺🇸Chesapeake, Virginia, United States
CCBR Vejle
🇩🇰Vejle, Denmark
BKS Research Kft.
🇭🇺Hatvan, Hungary
Synexus Magyarorszag Kft
🇭🇺Budapest, Hungary
Hevizgyogyfurdo es Szent Andraes ReumaKorhaz
🇭🇺Hévíz, Hungary
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
🇱🇹Kaunas, Lithuania
Republican Panevezys Hospital
🇱🇹Panevėžys, Lithuania
Center Outpation Clinic, Public Institution
🇱🇹Vilnius, Lithuania
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
🇵🇱Wrocław, Dolnoslaskie, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
🇵🇱Kraków, Malopolskie, Poland
MCBK Sc lwona Czajkowska Monika Barney
🇵🇱Grodzisk Mazowiecki, Mazowieckie, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
🇵🇱Gdynia, Pomorskie, Poland
ClinicMed Daniluk, Nowak Sp.j.
🇵🇱Białystok, Poland
Synexus Polska Sp. z o.o Oddzial w Poznaniu
🇵🇱Poznań, Wielkopolskie, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
🇵🇱Katowice, Poland
SC Policlinica CCBR SRL
🇷🇴Bucharest, Romania
Clinica Medicala Synexus Ltd.
🇷🇴Bucharest, Romania
"State Autonomous Healthcare Institution of Yaroslavl Oblast ""Clinical Hospital #3"""
🇷🇺Yaroslavl, Russian Federation
Samara Regional Clinical Hospital n.a.V.D.Seredavin
🇷🇺Samara, Russian Federation
Tread Research-Tygerberg Hospital
🇿🇦Parow, Cape Town, South Africa
Welkom Clinical trial Centre
🇿🇦Welkom, Free State, South Africa
Wits Clinical Research
🇿🇦Johannesburg, Gauteng, South Africa
Global Clinical Trials
🇿🇦Pretoria, Gauteng, South Africa
Synexus SA Stanza Clinical Research Centre
🇿🇦Pretoria, Gauteng, South Africa
Roodepoort Medicross Clinical Research Centre
🇿🇦Roodepoort, Gauteng, South Africa
Soweto Clinical Trials Centre (CTC)
🇿🇦Soweto, Johannesburg, South Africa
Aliwal Shoal Medical Centre
🇿🇦Umkomaas, Kwa-Zulu Natal, South Africa
Enhancing Care
🇿🇦Durban, KwaZulu-Natal, South Africa
Paarl Research Centre
🇿🇦Paarl, Western Cape, South Africa
TASK Applied Science
🇿🇦Cape Town, South Africa
Newtown Clinical Research
🇿🇦Johannesburg, South Africa
CETA Leganes
🇪🇸Leganés, Madrid, Spain
Complejo Hospitalario Universitario A Coruna
🇪🇸A Coruña, Spain
Clínica Nuevas Tecnologias en Diabetes y Endocrinologia (NTDE)
🇪🇸Sevilla, Spain
MeDiNova Investigacion y Desarrollo
🇪🇸Madrid, Spain
Centro De Investigacion Clinica En Enfermedades Cronicas - Cicec
🇪🇸Santiago De Compostela, Spain
Kharkiv City Multispecialty Hospital #18
🇺🇦Kharkiv, Ukraine
Hospital Quiron Salud Infanta Luisa
🇪🇸Sevilla, Spain
"Kyiv Railway Clinical Hospital No.2 of branch ""Health Center "" of the PJSC ""Ukrainian Railway"""
🇺🇦Kyiv, Ukraine
Lviv Regional Hospital for veterans of the war and former political prisoners
🇺🇦Lviv, Ukraine
Synexus Thames Valley Clinical Research Centre
🇬🇧Reading, Berkshire, United Kingdom
MediNova North London Dedicated Research Centre, Mount Vernon Hospital
🇬🇧Northwood, Middlesex, United Kingdom
Synexus Wales Clinical Research Centre
🇬🇧Cardiff, United Kingdom
Synexus Manchester Clinical Research Centre-Manchester Science Park
🇬🇧Manchester, United Kingdom
Medinova Research East London Clinical Studies Centre
🇬🇧Romford, United Kingdom
MeDiNova Research Yorkshire Clinical Studies Centre
🇬🇧Shipley, United Kingdom
MediNova South London Dedicated Research Centre
🇬🇧Sidcup, United Kingdom
Sensible Healthcare
🇺🇸Ocoee, Florida, United States
Lovelace Scientific Resources
🇺🇸Venice, Florida, United States
Healthcare Research Network II, LLC
🇺🇸Flossmoor, Illinois, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Lynn Institute of Denver
🇺🇸Aurora, Colorado, United States
Sterling Research Group, Ltd.
🇺🇸Cincinnati, Ohio, United States
Hillcrest Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
The Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Synexus Watermeyer Clinical Research Centre
🇿🇦Pretoria, Gauteng, South Africa
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
Synapta Clinical Research Center
🇿🇦Durban, Kwa-Zulu Natal, South Africa
Jewett Orthopaedic Clinic
🇺🇸Orlando, Florida, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Synexus Polska Sp. z o.o. Oddzial w Gdyni
🇵🇱Gdynia, Pomorskie, Poland
Etg Zgierz
🇵🇱Zgierz, Poland
City Out-Patient Clinic #109
🇷🇺Saint Petersburg, Russian Federation
Clinical Research Solutions
🇺🇸Franklin, Tennessee, United States
Qualiclinic Kft.
🇭🇺Budapest, Hungary
Synexus Magyarorszag Egeszsegugyi Kft.
🇭🇺Zalaegerszeg, Hungary
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o.
🇵🇱Warszawa, Mazowieckie, Poland
Malopolskie Centrum Kliniczne
🇵🇱Kraków, Poland
CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
🇵🇱Skierniewice, Poland
Rheumatology & Pulmonary Clinic
🇺🇸Beckley, West Virginia, United States
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Josa Andras Oktatokorhaza Klinikai Kutatasi Osztaly
🇭🇺Nyíregyháza, Hungary
Saules Seimos Medicinos Centras, Jsc
🇱🇹Kaunas, Lithuania
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02 - SOMED - Lodzkie Centrum Osteoporozy
🇵🇱Łódź, Lodzkie, Poland
PMG Research of Knoxville
🇺🇸Knoxville, Tennessee, United States
Langeberg Medicross Medical Centre
🇿🇦Kraaifontein, Western Cape, South Africa
Synexus Magyarorszag Kft.
🇭🇺Gyula, Hungary
Synexus Helderberg Clinical Trial Centre
🇿🇦Somerset West, Western Cape, South Africa
Synexus North East Clinical Research Centre - Hexham General Hospital
🇬🇧Hexham, Northumberland, United Kingdom
Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Mesa, Arizona, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
Low Country Rheumatology, PA
🇺🇸Charleston, South Carolina, United States