Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:8/2/2018
Start Date:December 2011
End Date:January 2016

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

A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate

This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy
of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in
the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding
adequately to MTX.


Inclusion Criteria:

- Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined by
the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology
(ACR) classification criteria (Aletaha D et al, 2010)

- Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic
Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at
Screening

- Subject must have moderate to severe RA disease at Screening and Baseline defined as:

1. Screening (all criteria required)

- ≥ 4 swollen joints (of 28 prespecified joints)

- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2

- C-Reactive Protein (CRP) concentration ≥ 10 mg/L (or 1.0 mg/dL) or
Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hr

2. Baseline (both criteria required)

- ≥ 4 swollen joints (of 28 prespecified joints)

- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2

- Subject must have inadequately responded previously to Methotrexate (MTX)

- Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has
used the same MTX regimen for a minimum of 28 days prior to Baseline

Exclusion Criteria:

- Subject has previously received any biological Disease Modifying Antirheumatic Drug
(DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase,
phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine
kinase

- Diagnosis of any other inflammatory arthritis

- Infected with Tuberculosis (TB) or high risk of acquiring TB infection

- Subjects with concurrent acute or chronic viral hepatitis B or C infection

- Subjects with a history of chronic or recurrent infections or subjects at high risk of
infection

- Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological
DMARDs excluding study medications, experimental therapy, IA hyaluronic acid
We found this trial at
60
sites
617
mi
from 98109
Roseville, CA
Click here to add this to my saved trials
2348
mi
from 98109
Albany, NY
Click here to add this to my saved trials
1184
mi
from 98109
Albuquerque, NM
Click here to add this to my saved trials
2320
mi
from 98109
Arlington, VA
Click here to add this to my saved trials
1775
mi
from 98109
Austin, TX
Click here to add this to my saved trials
2724
mi
from 98109
Aventura, FL
Click here to add this to my saved trials
2328
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
1834
mi
from 98109
Battle Creek, MI
Click here to add this to my saved trials
2341
mi
from 98109
Bethlehem, PA
Click here to add this to my saved trials
2079
mi
from 98109
Birmingham, AL
Click here to add this to my saved trials
2404
mi
from 98109
Brooklyn, NY
Click here to add this to my saved trials
7750
mi
from 98109
Camperdown,
Click here to add this to my saved trials
Charleston, South Carolina 29412
2424
mi
from 98109
Charleston, SC
Click here to add this to my saved trials
1967
mi
from 98109
Cincinnati, OH
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
2155
mi
from 98109
Clarksburg, WV
Click here to add this to my saved trials
259
mi
from 98109
Coeur D'Alene, ID
Click here to add this to my saved trials
1916
mi
from 98109
Corpus Christi, TX
Click here to add this to my saved trials
964
mi
from 98109
Covina, CA
Click here to add this to my saved trials
1682
mi
from 98109
Dallas, TX
Click here to add this to my saved trials
1933
mi
from 98109
Detroit, MI
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
2205
mi
from 98109
Duncansville, PA
Click here to add this to my saved trials
1398
mi
from 98109
Eagan, MN
Click here to add this to my saved trials
2717
mi
from 98109
Fort Lauderdale, FL
Click here to add this to my saved trials
976
mi
from 98109
Fullerton, CA
Click here to add this to my saved trials
2450
mi
from 98109
Gainesville, FL
Click here to add this to my saved trials
1684
mi
from 98109
Glendale, WI
Click here to add this to my saved trials
1760
mi
from 98109
Hot Springs, AR
Click here to add this to my saved trials
1890
mi
from 98109
Houston, TX
Click here to add this to my saved trials
1897
mi
from 98109
Jackson, TN
Click here to add this to my saved trials
2113
mi
from 98109
Knoxville, TN
Click here to add this to my saved trials
1063
mi
from 98109
La Mesa, CA
Click here to add this to my saved trials
1853
mi
from 98109
Lansing, MI
Click here to add this to my saved trials
2414
mi
from 98109
Lewes, DE
Click here to add this to my saved trials
2005
mi
from 98109
Lexington, KY
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
1723
mi
from 98109
Maywood, IL
Click here to add this to my saved trials
1000
mi
from 98109
Menifee, CA
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
2435
mi
from 98109
Myrtle Beach, SC
Click here to add this to my saved trials
1523
mi
from 98109
Oklahoma City, OK
Click here to add this to my saved trials
1366
mi
from 98109
Omaha, NE
Click here to add this to my saved trials
2351
mi
from 98109
Orangeburg, SC
Click here to add this to my saved trials
?
mi
from 98109
Orchard Park, NY
Click here to add this to my saved trials
2428
mi
from 98109
Plainview, NY
Click here to add this to my saved trials
576
mi
from 98109
Reno, NV
Click here to add this to my saved trials
1450
mi
from 98109
Rochester, MN
Click here to add this to my saved trials
626
mi
from 98109
Sacramento, CA
Click here to add this to my saved trials
1388
mi
from 98109
Saint Louis Park, MN
Click here to add this to my saved trials
1790
mi
from 98109
San Antonio, TX
Click here to add this to my saved trials
229
mi
from 98109
Spokane, WA
Click here to add this to my saved trials
1888
mi
from 98109
Sugar Land, TX
Click here to add this to my saved trials
2231
mi
from 98109
Syracuse, NY
Click here to add this to my saved trials
2395
mi
from 98109
Teaneck, NJ
Click here to add this to my saved trials
1220
mi
from 98109
Tucson, AZ
Click here to add this to my saved trials
2058
mi
from 98109
Tuscaloosa, AL
Click here to add this to my saved trials
949
mi
from 98109
Van Nuys, CA
Click here to add this to my saved trials
2633
mi
from 98109
Vero Beach, FL
Click here to add this to my saved trials
1877
mi
from 98109
Victoria, TX
Click here to add this to my saved trials
2385
mi
from 98109
Voorhees, NJ
Click here to add this to my saved trials
970
mi
from 98109
Whittier, CA
Click here to add this to my saved trials
2323
mi
from 98109
Wyomissing, PA
Click here to add this to my saved trials