Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
- Conditions
- Osteoarthritis, KneeOsteoarthritis, Hip
- Interventions
- Registration Number
- NCT03304379
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.
The secondary objectives of the study are:
* To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
* To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 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
- 1650
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dosing regimen 2 Diclofenac - Dosing regimen 2 Matching placebo - Dosing regimen 3 Celecoxib - Dosing regimen 3 Matching placebo - Dosing regimen 4 Matching placebo - Dosing regimen 1 Matching placebo - Dosing regimen 1 Fasinumab -
- Primary Outcome Measures
Name Time Method Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo Baseline up to Week 24 WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo Baseline up to Week 24 Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo Baseline up to Week 24 WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo Baseline up to Week 24 The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs Baseline up to Week 24 WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs Baseline up to Week 24 Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs Baseline up to Week 24 The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale Baseline up to Week 24 Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.
Number of Participants With Adjudicated Arthropathy (AA) Events Baseline up to follow-up period (Week 44) AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria Baseline up to follow-up period (Week 44) DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Baseline up to follow-up period (Week 44) An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as an AE with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.
Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events Baseline up to follow-up period (Week 44) Potential events of SNS dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.
Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs) Baseline up to Week 44 Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).
Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24 Baseline up to Week 24 Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.
Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44 Baseline up to Week 44 Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.
Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72) At Week 72 An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.
Serum Concentrations of Functional Fasinumab At Weeks 0, 4, 8, 16, 24 and 44 Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development Baseline up to Week 44 Immunogenicity was characterized by ADA responses \& titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, \>= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.
Trial Locations
- Locations (69)
Advance Research Center
🇺🇸Anaheim, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Clinical Research Advantage, Inc./Warner Family Practice, PC
🇺🇸Chandler, Arizona, United States
Synexus Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States
Affinity Clinical Research Institute
🇺🇸Oak Lawn, Illinois, United States
California Research Foundation
🇺🇸San Diego, California, United States
Westlake Medical Research
🇺🇸Thousand Oaks, California, United States
Georgia Institute For Clinical Research LLC
🇺🇸Marietta, Georgia, United States
Lakes Research, LLC
🇺🇸Miami Lakes, Florida, United States
Center for Orthopaedics and Sports Medicine
🇺🇸Indiana, Pennsylvania, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Meridian Clinical Research Associates, LLC
🇺🇸Omaha, Nebraska, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Robert Kaplan, D.O.
🇺🇸Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
DOC Clinical Research
🇺🇸Dayton, Ohio, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Piedmont Research Partners, LLC
🇺🇸Indian Land, South Carolina, United States
Synexus USA
🇺🇸Plano, Texas, United States
Coastal Carolina Research Center at LowCountry Orthopaedics
🇺🇸North Charleston, South Carolina, United States
Clinical Investigations Of Texas
🇺🇸Plano, Texas, United States
ACME Research, LLC
🇺🇸Orangeburg, South Carolina, United States
West Texas Clinical Research
🇺🇸Lubbock, Texas, United States
Health Research of Hampton Roads, Inc
🇺🇸Newport News, Virginia, United States
Clinical Research Advantage, Inc.
🇺🇸Evansville, Indiana, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Pinnacle Research Group, Llc
🇺🇸Anniston, Alabama, United States
Horizon Research Partners
🇺🇸Mobile, Alabama, United States
TriWest Research Associates, LLC
🇺🇸El Cajon, California, United States
Clinical Research Consortium Arizona
🇺🇸Tempe, Arizona, United States
UC Davis Center for Musculoskeletal Health
🇺🇸Sacramento, California, United States
Advanced Research Center, Inc
🇺🇸San Diego, California, United States
Paragon Rx Clinical Research, Inc
🇺🇸Santa Ana, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
New England Research Associates, LLC
🇺🇸Bridgeport, Connecticut, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
CRM of Greater New Haven, LLC
🇺🇸Hamden, Connecticut, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Bioclinica Research
🇺🇸Orlando, Florida, United States
Integral Rheumatology & Immunology Specialists (IRIS)
🇺🇸Plantation, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Allied Biomedical Research Institute
🇺🇸Miami, Florida, United States
Chicago Clinical Research Institute, Inc
🇺🇸Chicago, Illinois, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Tufts Medical Center, Inc.
🇺🇸Boston, Massachusetts, United States
Skyline Medical Center /Radiant Research, Inc.
🇺🇸Elkhorn, Nebraska, United States
Northwell Health
🇺🇸Great Neck, New York, United States
Upstate Clinical Research Associates, LLC
🇺🇸Williamsville, New York, United States
Carolina Research Center
🇺🇸Shelby, North Carolina, United States
PMG Research of Wilmington LLC
🇺🇸Wilmington, North Carolina, United States
The Center For Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Office of Dr.Ramesh C. Gupta MD
🇺🇸Memphis, Tennessee, United States
Charlottesville Medical Research Center LLC
🇺🇸Charlottesville, Virginia, United States
AMB Research Center, Inc
🇺🇸Miami, Florida, United States
Synexus Clinical Research US, Inc.
🇺🇸Richfield, Minnesota, United States
Paragon Rx Clinical Research, Inc.
🇺🇸Garden Grove, California, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
Radiant Research, Inc.
🇺🇸Greer, South Carolina, United States
Gulf Region Clinical Research institute
🇺🇸Pensacola, Florida, United States
Amici Clinical Research, LLC
🇺🇸Raritan, New Jersey, United States
Piedmont Comprehensive Pain Management Group
🇺🇸Greenville, South Carolina, United States
Drug Trial Brooklyn
🇺🇸Brooklyn, New York, United States
Spokane Joint Replacement Center
🇺🇸Spokane, Washington, United States
Onyx Clinical Research
🇺🇸Caro, Michigan, United States
Sierra Clinical Research
🇺🇸Roseville, California, United States