Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 80
Updated:5/5/2014
Start Date:October 2013
End Date:August 2015
Contact:Amgen Call Center
Phone:866-572-6436

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

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

The purpose of this study is to compare the effectiveness and safety of ABP 501 against
Adalimumab (Humira®) in adult subjects with moderate to severe rheumatoid arthritis (RA) who
have an inadequate response to methotrexate (MTX).


Inclusion Criteria:

1. Men or women ≥ 18 and ≤ 80 years old

2. Subjects must be diagnosed with Rheumatoid Arthritis for at least 3 months before
baseline

3. Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and
baseline

4. Subjects must be taking MTX for ≥ 12 consecutive weeks and on a stable dose of 7.5 to
25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain
on stable dose throughout the study

5. Subject has no known history of active tuberculosis

Exclusion Criteria:

1. Class IV RA, Felty's syndrome or history of prosthetic or native joint infection

2. Major chronic inflammatory disease or connective tissue disease other than RA, with
the exception of secondary Sjögren's syndrome

3. Prior use of 2 or more biologic therapies for RA

4. Previous receipt of Humira® (adalimumab) or a biosimilar of adalimumab

5. Ongoing use of prohibited treatments

Other Inclusion/Exclusion criteria may apply
We found this trial at
43
sites
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Covina, CA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
?
mi
from
Eagan, MN
Click here to add this to my saved trials
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
?
mi
from
Frederick, MD
Click here to add this to my saved trials
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
?
mi
from
Hemet, CA
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
?
mi
from
Lansing, MI
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
?
mi
from
Mineola, NY
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Palm Desert, CA
Click here to add this to my saved trials
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
?
mi
from
Reno, NV
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Sandy Springs, GA
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Tustin, CA
Click here to add this to my saved trials
?
mi
from
Van Nuys, CA
Click here to add this to my saved trials
?
mi
from
Venice, FL
Click here to add this to my saved trials
?
mi
from
Victorville, CA
Click here to add this to my saved trials
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
?
mi
from
Wheaton, MD
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials