Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip
NCT ID: NCT02447276
Last Updated: 2017-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
421 participants
INTERVENTIONAL
2015-05-31
2016-11-30
Brief Summary
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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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Group A
Group A will receive REGN475 dosing regimen 1
REGN475
Group B
Group B will receive REGN475 dosing regimen 2
REGN475
Group C
Group C will receive REGN475 dosing regimen 3
REGN475
Group D
Group D will receive REGN475 dosing regimen 4
REGN475
Group E
Group E will receive matching placebo
Placebo
Interventions
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REGN475
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of OA of the knee or hip
3. History of inadequate pain relief or intolerance to analgesics used for OA
4. Moderate to severe pain in the index joint
5. History of regular use of analgesic medications for OA pain
6. Willing to discontinue current non-steroidal anti-inflammatory drug (NSAID) and opioid pain medications
Exclusion Criteria
2. History of osteonecrosis, destructive arthropathy (RPOA), hip dislocation, pathologic fractures, neuropathic joint arthropathy, knee dislocation or hip dislocation
3. Trauma to the index joint in the 30 days before screening
4. Active fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA
5. Prior to the start of the study has received a recommendation for, or is scheduled for joint replacement surgery to be performed during the study period
6. Presence of subchondral insufficiency fracture on screening films or MRI
7. Received an intra-articular injection of hyaluronic acid in the affected index joint within 90 days prior to the screening visit
8. Systemic (ie, oral or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks of the screening visit, or to any other joint within 30 days prior to the screening visit.
9. History of autonomic neuropathy, diabetic neuropathy, or presence of clinically relevant peripheral neuropathy at the time of screening
10. Women of childbearing potential who have a positive pregnancy test result, or who do not have their pregnancy test results at baseline
11. Pregnant or breastfeeding women
40 Years
80 Years
ALL
No
Sponsors
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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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Birmingham, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Tuscon, Arizona, United States
Hot Spring, Arkansas, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Beverly Hills, California, United States
El Cajon, California, United States
Sacramento, California, United States
San Diego, California, United States
Santa Ana, California, United States
Thousand Oaks, California, United States
Upland, California, United States
Walnut Creek, California, United States
Lakewood, Colorado, United States
Clearwater, Florida, United States
Fleming Island, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Weston, Florida, United States
Winter Haven, Florida, United States
Decatur, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
Elkridge, Maryland, United States
Frederick, Maryland, United States
Worcester, Massachusetts, United States
Saint Clair Shores, Michigan, United States
Traverse City, Michigan, United States
Hattiesburg, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Brooklyn, New York, United States
Hartsdale, New York, United States
New York, New York, United States
Plainview, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Bensalem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Jackson, Tennessee, United States
Jefferson City, Tennessee, United States
Memphis, Tennessee, United States
Cypress, Texas, United States
Dallas, Texas, United States
Lubbock, Texas, United States
Mesquite, Texas, United States
Plano, Texas, United States
Waco, Texas, United States
Salt Lake City, Utah, United States
Sandy City, Utah, United States
West Jordan, Utah, United States
Norfolk, Virginia, United States
Countries
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References
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Dakin P, DiMartino SJ, Gao H, Maloney J, Kivitz AJ, Schnitzer TJ, Stahl N, Yancopoulos GD, Geba GP. The Efficacy, Tolerability, and Joint Safety of Fasinumab in Osteoarthritis Pain: A Phase IIb/III Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Arthritis Rheumatol. 2019 Nov;71(11):1824-1834. doi: 10.1002/art.41012. Epub 2019 Sep 20.
Other Identifiers
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R475-PN-1227
Identifier Type: -
Identifier Source: org_study_id
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