Clinical trial NCT02447276: Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Official title: A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 421
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effectiveness of REGN475 compared to placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history of inadequate joint pain relief or intolerance to current analgesic therapy.


Eligibility criteria: Key Inclusion Criteria:

1. Body mass index ≤39
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

Key Exclusion Criteria:

1. Other diseases that may involve index knee or hip, including inflammatory joint diseases, crystalline disease (gout or pseudogout), endocrinopathies, metabolic joint disease, lupus erythematosus, rheumatoid arthritis, joint infections, neuropathic disorders, avascular necrosis, Paget's disease, renal osteodystrophy or tumors
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

Primary outcomes:
measure: The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score.
timeFrame: Baseline to week 16
Secondary outcomes:
measure: Change from baseline to week 16 in the WOMAC physical function subscale score
timeFrame: Baseline to week 16
measure: Change from baseline to week 16 in the Patient Global Assessment score
timeFrame: Baseline to week 16
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline to week 36 (end of study)
measure: Incidence of anti-REGN475 antibody development
timeFrame: Baseline to week 36 (end of study)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tuscon
country: United States
state: Arizona
city: Hot Spring
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: El Cajon
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Thousand Oaks
country: United States
state: California
city: Upland
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Fleming Island
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: New Orleans
country: United States
state: Louisiana
city: Elkridge
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: St. Clair Shores
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Hattiesburg
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Brooklyn
country: United States
state: New York
city: Hartsdale
country: United States
state: New York
city: New York
country: United States
state: New York
city: Plainview
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Bensalem
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Mount Pleasant
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Jefferson City
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Cypress
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Sandy
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: 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.