Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip



Status:Completed
Conditions:Arthritis, Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - 80
Updated:12/24/2016
Start Date:May 2015
End Date:November 2016

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

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

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.


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
We found this trial at
72
sites
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
16
mi
from 91732
Anaheim, CA
Click here to add this to my saved trials
2386
mi
from 91732
Bensalem, PA
Click here to add this to my saved trials
Beverly Hills, California 90211
21
mi
from 91732
Beverly Hills, CA
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2434
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
356
mi
from 91732
Chandler, AZ
Click here to add this to my saved trials
Charlotte, North Carolina 28207
2102
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
2117
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
1335
mi
from 91732
Cypress, TX
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1924
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
2200
mi
from 91732
Duncansville, PA
Click here to add this to my saved trials
106
mi
from 91732
El Cajon, CA
Click here to add this to my saved trials
2296
mi
from 91732
Elkridge, MD
Click here to add this to my saved trials
2131
mi
from 91732
Fleming Island, FL
Click here to add this to my saved trials
2258
mi
from 91732
Frederick, MD
Click here to add this to my saved trials
2442
mi
from 91732
Hartsdale, NY
Click here to add this to my saved trials
1676
mi
from 91732
Hattiesburg, MS
Click here to add this to my saved trials
2141
mi
from 91732
High Point, NC
Click here to add this to my saved trials
2573
mi
from 91732
Honolulu, HI
Click here to add this to my saved trials
1427
mi
from 91732
Hot Spring, AR
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
1653
mi
from 91732
Jackson, TN
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Jefferson City, Tennessee 37760
1946
mi
from 91732
Jefferson City, TN
Click here to add this to my saved trials
2377
mi
from 91732
Jenkintown, PA
Click here to add this to my saved trials
1341
mi
from 91732
Kansas City, MO
Click here to add this to my saved trials
812
mi
from 91732
Lakewood, CO
Click here to add this to my saved trials
1463
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
925
mi
from 91732
Lubbock, TX
Click here to add this to my saved trials
1586
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
1235
mi
from 91732
Mesquite, TX
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
1757
mi
from 91732
Mobile, AL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
2187
mi
from 91732
Mount Pleasant, SC
Click here to add this to my saved trials
1655
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
2117
mi
from 91732
Palm Harbor, FL
Click here to add this to my saved trials
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
2461
mi
from 91732
Plainview, NY
Click here to add this to my saved trials
1227
mi
from 91732
Plano, TX
Click here to add this to my saved trials
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
364
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
561
mi
from 91732
Sandy, UT
Click here to add this to my saved trials
24
mi
from 91732
Santa Ana, CA
Click here to add this to my saved trials
1975
mi
from 91732
St. Clair Shores, MI
Click here to add this to my saved trials
1572
mi
from 91732
St. Louis, MO
Click here to add this to my saved trials
2306
mi
from 91732
Tamarac, FL
Click here to add this to my saved trials
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Thousand Oaks, California 91360
50
mi
from 91732
Thousand Oaks, CA
Click here to add this to my saved trials
1861
mi
from 91732
Traverse City, MI
Click here to add this to my saved trials
1253
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
435
mi
from 91732
Tuscon, AZ
Click here to add this to my saved trials
20
mi
from 91732
Upland, CA
Click here to add this to my saved trials
1219
mi
from 91732
Waco, TX
Click here to add this to my saved trials
347
mi
from 91732
Walnut Creek, CA
Click here to add this to my saved trials
2560
mi
from 91732
Warwick, RI
Click here to add this to my saved trials
561
mi
from 91732
West Jordan, UT
Click here to add this to my saved trials
2304
mi
from 91732
West Palm Beach, FL
Click here to add this to my saved trials
2303
mi
from 91732
Weston, FL
Click here to add this to my saved trials
2176
mi
from 91732
Winter Haven, FL
Click here to add this to my saved trials
2540
mi
from 91732
Worcester, MA
Click here to add this to my saved trials