Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip



Status:Active, not recruiting
Conditions:Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 28, 2016
End Date:January 13, 2020

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A Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

This study of up to 7,000 participants will further characterize the safety profile of
fasinumab.

A subset of approximately 1,000 participants at select sites will also participate in a
sub-study to characterize the efficacy of fasinumab.


Key Inclusion Criteria:

1. Male or female ≥18 years of age at the screening visit

2. Clinical diagnosis of OA of the knee or hip based on the American College of
Rheumatology criteria with radiologic evidence of OA (K-L score ≥2) for the index
joint at the screening visit

3. Moderate to severe pain in the index joint defined as a WOMAC average pain subscale
score of ≥4

4. A history of 12 weeks of analgesic use for OA of the knee or hip

5. History of regular use of analgesic medications for OA pain

Key Exclusion Criteria:

1. History or presence at the screening visit of non OA inflammatory joint disease

2. History or presence on imaging of arthropathy, stress fracture, recent stress
fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital
hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence
of bone fragmentation or collapse, or primary metastatic tumor with the exception of
chondromas or pathologic fracture during the screening period

3. Patient is not a candidate for MRI

4. Is scheduled for a joint replacement surgery to be performed during the study period

5. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the
screening visit.

6. History or presence at the screening visit of multiple sclerosis, autonomic
neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex
sympathetic dystrophy

7. History or diagnosis of chronic autonomic failure syndrome including pure autonomic
failure, multiple system atrophy

8. Pregnant or breast-feeding women

9. Women of childbearing potential who have a positive pregnancy test result or do not
have their pregnancy test result at baseline

Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
50
sites
626
mi
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Edina, MN
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110
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Akron, OH
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Anderson, South Carolina
377
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Anderson, SC
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Atlanta, Georgia
436
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Atlanta, GA
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Aurora, Colorado
1154
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Aurora, CO
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Beverly Hills, California
1979
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Beverly Hills, CA
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Birmingham, Alabama
491
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Birmingham, AL
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5274
mi
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Burgas,
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Carlsbad, California
1949
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Carlsbad, CA
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Chandler, Arizona
1654
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Chandler, AZ
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Chicago, Illinois
274
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Chicago, IL
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Cincinnati, Ohio
94
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Cincinnati, OH
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Clearwater, Florida
829
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Clearwater, FL
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Colorado Springs, Colorado
1163
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Colorado Springs, CO
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Columbus, Ohio
1
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Columbus, OH
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Council Bluffs, Iowa
678
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Council Bluffs, IA
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911
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Dallas, TX
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Duncansville, Pennsylvania 16635
244
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Duncansville, PA
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Elkhorn, Nebraska
698
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Elkhorn, NE
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Evansville, Illinois
392
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Evansville, IL
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Frederick, Maryland
300
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Frederick, MD
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Fremont, Nebraska
711
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Fremont, NE
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Glendale, Arizona
1665
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Glendale, AZ
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Greer, South Carolina
350
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Greer, SC
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Henderson, Nevada
1751
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Henderson, NV
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High Point, North Carolina
322
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High Point, NC
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Houston, Texas
991
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Houston, TX
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Jamaica, New York
487
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Jamaica, NY
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Lakewood, Colorado
1167
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Lakewood, CO
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Las Vegas, Nevada
1756
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Las Vegas, NV
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Little Rock, Arkansas
623
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Little Rock, AR
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Littleton, Colorado
1164
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Littleton, CO
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1128
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Lubbock, TX
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1650
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Mesa, AZ
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New York, New York
477
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New York, NY
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Oklahoma City, Oklahoma
849
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Oklahoma City, OK
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Orlando, Florida
795
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Orlando, FL
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1662
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Phoenix, AZ
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Pinellas Park, Florida
837
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Pinellas Park, FL
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896
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Plano, TX
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Raleigh, North Carolina
375
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Raleigh, NC
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Saint Louis, Missouri
394
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Saint Louis, MO
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San Antonio, Texas
1138
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San Antonio, TX
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San Diego, California
1951
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San Diego, CA
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Santa Rosa, California
2109
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Santa Rosa, CA
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Scottsdale, Arizona
1651
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1654
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Tempe, AZ
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1639
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Tucson, AZ
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Vista, California
1942
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Vista, CA
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Worcester, Massachusetts
604
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Worcester, MA
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