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



Status:Recruiting
Conditions:Arthritis, Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:October 26, 2017
End Date:June 15, 2020
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com
Phone:844-734-6643

Use our guide to learn which trials are right for you!

Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip

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 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 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 OA of the knee or hip


Key Inclusion Criteria (additional criteria may apply at screening):

1. A clinical diagnosis of osteoarthritis (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.

2. Willing to discontinue current pain medications and to adhere to study requirements
for rescue treatments (paracetamol/acetaminophen to be taken as needed with a maximum
daily dose of 2500 mg in Europe and 2600 mg in countries outside of Europe)

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

Key Exclusion Criteria (additional criteria may apply at screening):

1. Non-compliance with the numeric rating scale (NRS) recording during the
pre-randomization period

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 corticosteroid 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
We found this trial at
68
sites
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
?
mi
from
DeLand, FL
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
400 Tower Rd Ne
Marietta, Georgia 30060
678-581-5252
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Anaheim, California 92805
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Anniston, Alabama 36207
?
mi
from
Anniston, AL
Click here to add this to my saved trials
Bay City, Michigan 48706
?
mi
from
Bay City, MI
Click here to add this to my saved trials
4641 Main Street
Bridgeport, Connecticut 06606
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Brooklyn, New York 11230
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Caro, Michigan 48723
?
mi
from
Caro, MI
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charlottesville, Virginia 22911
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dayton, Ohio
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Denver, Colorado 80209
?
mi
from
Denver, CO
Click here to add this to my saved trials
El Cajon, California 92020
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
?
mi
from
Elkhorn, NE
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
10672 Chapman Avenue
Garden Grove, California 92840
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Great Neck, New York
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greenville, South Carolina 29601
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
Hartsdale, New York 10530
?
mi
from
Hartsdale, NY
Click here to add this to my saved trials
Indian Land, South Carolina 29707
?
mi
from
Indian Land, SC
Click here to add this to my saved trials
841 Hospital Road
Indiana, Pennsylvania 15701
?
mi
from
Indiana, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89144
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Louisville, Kentucky 40213
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lubbock, Texas 79410
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
1101 Medical Center Boulevard
Marrero, Louisiana 70072
?
mi
from
Marrero, LA
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33144
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Mobile, Alabama 36608
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Montclair, California 91763
?
mi
from
Montclair, CA
Click here to add this to my saved trials
Newport News, Virginia 23606
?
mi
from
Newport News, VA
Click here to add this to my saved trials
North Charleston, South Carolina 29406
?
mi
from
North Charleston, SC
Click here to add this to my saved trials
Oak Lawn, Illinois 60453
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
100 West Gore Street
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
Plano, Texas 75093
?
mi
from
Plano, TX
Click here to add this to my saved trials
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Raritan, New Jersey 08869
?
mi
from
Raritan, NJ
Click here to add this to my saved trials
Richfield, Minnesota 55423
?
mi
from
Richfield, MN
Click here to add this to my saved trials
Roseville, California 95661
?
mi
from
Roseville, CA
Click here to add this to my saved trials
Sacramento, California 95827
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92703
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Shelby, North Carolina 28150
?
mi
from
Shelby, NC
Click here to add this to my saved trials
Spokane, Washington 99218
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Spring Valley, California 91978
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
Stamford, Connecticut 06095
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
Thousand Oaks, California 91360
?
mi
from
Thousand Oaks, CA
Click here to add this to my saved trials
Vista, California 92083
?
mi
from
Vista, CA
Click here to add this to my saved trials
1202 Medical Center Drive
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Woodstock, Georgia 30189
?
mi
from
Woodstock, GA
Click here to add this to my saved trials