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
NCT ID: NCT03304379
Last Updated: 2023-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1650 participants
INTERVENTIONAL
2017-10-26
2020-11-09
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dosing regimen 1
Fasinumab
Solution for injection in pre-filled syringe
Matching placebo
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
Dosing regimen 2
Diclofenac
NSAID active comparator (capsule)
Matching placebo
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
Dosing regimen 3
Celecoxib
NSAID active comparator (capsule)
Matching placebo
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
Dosing regimen 4
Matching placebo
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
Interventions
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Fasinumab
Solution for injection in pre-filled syringe
Diclofenac
NSAID active comparator (capsule)
Celecoxib
NSAID active comparator (capsule)
Matching placebo
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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 \[countries where 325 mg strength tablets/capsules are available\])
3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics used for pain due to OA of the knee or hip
4. Currently using a stable dose of NSAID
5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the 24 weeks of treatment
Exclusion Criteria
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, hip or knee dislocation, extensive subchondral cysts, evidence of severe structural damage, bone collapse, or primary metastatic tumor with the exception of chondromas 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 magnetic resonance imaging (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. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)
10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
11. Use of systemic corticosteroids 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
12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies
13. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 20 weeks after the last dose
18 Years
ALL
No
Sponsors
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Teva Pharmaceutical Industries, Ltd.
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Pinnacle Research Group, Llc
Anniston, Alabama, United States
Horizon Research Partners
Mobile, Alabama, United States
Clinical Research Advantage, Inc./Warner Family Practice, PC
Chandler, Arizona, United States
Synexus Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Clinical Research Consortium Arizona
Tempe, Arizona, United States
Advance Research Center
Anaheim, California, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Paragon Rx Clinical Research, Inc.
Garden Grove, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Sierra Clinical Research
Roseville, California, United States
UC Davis Center for Musculoskeletal Health
Sacramento, California, United States
Advanced Research Center, Inc
San Diego, California, United States
California Research Foundation
San Diego, California, United States
Paragon Rx Clinical Research, Inc
Santa Ana, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Westlake Medical Research
Thousand Oaks, California, United States
Synexus Clinical Research US, Inc.
Vista, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
New England Research Associates, LLC
Bridgeport, Connecticut, United States
CRM of Greater New Haven, LLC
Hamden, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
AMB Research Center, Inc
Miami, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Lakes Research, LLC
Miami Lakes, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Gulf Region Clinical Research institute
Pensacola, 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
Georgia Institute For Clinical Research LLC
Marietta, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Chicago Clinical Research Institute, Inc
Chicago, Illinois, United States
Affinity Clinical Research Institute
Oak Lawn, Illinois, 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
Tandem Clinical Research
Marrero, Louisiana, United States
Tufts Medical Center, Inc.
Boston, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Onyx Clinical Research
Caro, Michigan, United States
Synexus Clinical Research US, Inc.
Richfield, Minnesota, United States
Skyline Medical Center /Radiant Research, Inc.
Elkhorn, Nebraska, United States
Meridian Clinical Research Associates, LLC
Omaha, Nebraska, United States
Robert Kaplan, D.O.
Las Vegas, Nevada, United States
Amici Clinical Research, LLC
Raritan, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Drug Trial Brooklyn
Brooklyn, New York, United States
Northwell Health
Great Neck, New York, United States
Drug Trials America
Hartsdale, 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
Aventiv Research Inc
Columbus, Ohio, United States
DOC Clinical Research
Dayton, Ohio, United States
Center for Orthopaedics and Sports Medicine
Indiana, Pennsylvania, United States
Radiant Research, Inc.
Anderson, South Carolina, United States
Piedmont Comprehensive Pain Management Group
Greenville, South Carolina, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Coastal Carolina Research Center at LowCountry Orthopaedics
North Charleston, South Carolina, United States
Piedmont Research Partners, LLC
Old Point Station, South Carolina, United States
ACME Research, LLC
Orangeburg, South Carolina, United States
Office of Dr.Ramesh C. Gupta MD
Memphis, Tennessee, United States
West Texas Clinical Research
Lubbock, Texas, United States
Clinical Investigations Of Texas
Plano, Texas, United States
Synexus USA
Plano, Texas, United States
Charlottesville Medical Research Center LLC
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc
Newport News, Virginia, United States
Spokane Joint Replacement Center
Spokane, Washington, United States
Countries
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References
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DiMartino SJ, Gao H, Eng S, Valenzuela G, Fuerst T, Emeremni C, Ho T, Hassan HE, Turner KC, Davis JD, Zaim S, Chao J, Patel Y, Brener L, Trinh N, Manvelian G, Fetell M, Braunstein N, Geba GP, Dakin P. Efficacy and safety of fasinumab in an NSAID-controlled study in patients with pain due to osteoarthritis of the knee or hip. BMC Musculoskelet Disord. 2025 Feb 25;26(1):192. doi: 10.1186/s12891-025-08402-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001702-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R475-OA-1688
Identifier Type: -
Identifier Source: org_study_id
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