A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors



Status:Completed
Conditions:Arthritis, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Rheumatology
Healthy:No
Age Range:50 - Any
Updated:8/3/2016
Start Date:August 2011
End Date:June 2016

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

A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of
cardiovascular events of tocilizumab in comparison to etanercept in participants with
rheumatoid arthritis. Participants will be randomized to receive intravenous (IV) 8
milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 mg etanercept
weekly, with or without non-biologic disease modifying anti-rheumatic drug (DMARD). The
anticipated time on study drug is up to 5 years.


Inclusion Criteria:

- Male and female participants, greater than or equal to (>/=) 50 years of age

- Participants with moderate to severe rheumatoid arthritis of >/=6 months duration

- Inadequate response to at least one non-biologic DMARD

- Positive for Rheumatoid Factor (RF) and/or anti-cyclic citrullinated peptide (CCP)
antibodies at screening

- Have a C-Reactive Protein (CRP) greater than (>) 0.3 milligrams per deciliter (mg/dL)
at screening or at the baseline visit

- Swollen joint count (SJC) and Tender joint count (TJC) >/= 8 during screening or at
the baseline visit

- History of Coronary Heart Disease (CHD) or presence of one or more additional CHD
risk factors, including current cigarette smoking, hypertension, low High Density
Lipoprotein (HDL) cholesterol, family history of premature CHD, diabetes, presence of
extra-articular disease associated with rheumatoid arthritis

- At the time of randomization, will have discontinued infliximab, adalimumab,
golimumab, or certolizumab for >/= 4 weeks

- Females of childbearing potential must have a negative pregnancy test within 28 days
of randomization and must be ready to use reliable contraceptive methods

Exclusion Criteria:

- Major surgery (including joint surgery or coronary revascularization) within 8 weeks
prior to screening or planned major surgery within 1 year of study start

- Rheumatic autoimmune disease other than rheumatoid arthritis

- History of, or current, inflammatory joint disease other than rheumatoid arthritis

- Current or recent (within past 3 months) evidence of serious uncontrolled concomitant
cardiovascular or cerebrovascular disease (Myocardial infarction, revascularization,
stroke, transient ischemic attack, or acute coronary syndrome)

- Current or previous (within the past 2 years) evidence of serious uncontrolled
concomitant pulmonary (including obstructive pulmonary disease), renal, hepatic,
endocrine (including uncontrolled diabetes mellitus) or gastrointestinal disease

- Uncontrolled disease states, such as asthma or inflammatory bowel disease where
flares are commonly treated with oral or parenteral corticosteroids

- Pre-existing central nervous system demyelinating or seizure disorders

- History of diverticulitis, diverticulosis requiring treatment or other lower
gastrointestinal tract conditions that might predispose to perforations

- Current liver disease as determined by the investigator; a history of asymptomatic
elevations in liver function tests (LFTs) is not considered an exclusion

- Active current infection or history of recurrent bacterial, viral, fungal,
mycobacterial or other infections, including but not limited to tuberculosis and
atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding
fungal infections of nail beds

- Any major episode of infection requiring hospitalization or treatment with
intravenous (IV) antibiotics within four weeks of screening or oral antibiotics
within two weeks prior to screening visit

- Active tuberculosis (TB) requiring treatment within 3 years prior to baseline

- Latent TB diagnosed during screening that has not been appropriately treated

- Primary or secondary immunodeficiency (history of or currently active)

- Moderate to severe heart failure

- Evidence of active malignant disease, malignancies diagnosed within the previous 10
years (including hematologic malignancies and solid tumors, except basal cell
carcinoma of the skin that has been excised and cured), or breast cancer diagnosed
within the previous 20 years

- Breast feeding mothers

- History of alcohol, drug or chemical abuse within the six months prior to screening

- Participants with lack of peripheral venous access

- Participants with a history of allergic reactions to latex

- Previous treatment with non-TNF-inhibitor biologic therapy

- Treatment with any investigational agent within four weeks of screening visit

- Treatment with any cell depleting therapies within 1 year of baseline

- Treatment with IV gamma globulin, plasmapheresis or Prosorba? column within six
months of baseline visit

- Immunization with a live/attenuated vaccine within four weeks prior to baseline visit

- Any previous treatment with alkylating agents, such as cyclophosphamide or
chlorambucil, or with total lymphoid irradiation
We found this trial at
145
sites
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
922
mi
from 91732
Amarillo, TX
Click here to add this to my saved trials
2002
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
2062
mi
from 91732
Beckley, WV
Click here to add this to my saved trials
Berkeley Heights, New Jersey 07922
2410
mi
from 91732
Berkeley Heights, NJ
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
665
mi
from 91732
Boise, ID
Click here to add this to my saved trials
665
mi
from 91732
Boise, ID
Click here to add this to my saved trials
665
mi
from 91732
Boise, ID
Click here to add this to my saved trials
1777
mi
from 91732
Bowling Green, KY
Click here to add this to my saved trials
2309
mi
from 91732
Boynton Beach, FL
Click here to add this to my saved trials
2473
mi
from 91732
Bridgeport, CT
Click here to add this to my saved trials
2434
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
2434
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
6113
mi
from 91732
Buenos Aires,
Click here to add this to my saved trials
2269
mi
from 91732
Burke, VA
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
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
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
Clarksburg, West Virginia 26301
2102
mi
from 91732
Clarksburg, WV
Click here to add this to my saved trials
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
941
mi
from 91732
Coeur D'Alene, ID
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
2104
mi
from 91732
Columbia, SC
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
2318
mi
from 91732
Coral Gables, FL
Click here to add this to my saved trials
1293
mi
from 91732
Corpus Christi, TX
Click here to add this to my saved trials
7
mi
from 91732
Covina, CA
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
2187
mi
from 91732
Daytona Beach, FL
Click here to add this to my saved trials
1930
mi
from 91732
Duluth, 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
2202
mi
from 91732
Durham, NC
Click here to add this to my saved trials
1508
mi
from 91732
Eagan, MN
Click here to add this to my saved trials
Fall River, Massachusetts 02720
2576
mi
from 91732
Fall River, MA
Click here to add this to my saved trials
2489
mi
from 91732
Farmington, CT
Click here to add this to my saved trials
1935
mi
from 91732
Flint, MI
Click here to add this to my saved trials
1611
mi
from 91732
Flowood, MS
Click here to add this to my saved trials
1853
mi
from 91732
Fort Wayne, IN
Click here to add this to my saved trials
1194
mi
from 91732
Fort Worth, TX
Click here to add this to my saved trials
14
mi
from 91732
Glendale, AZ
Click here to add this to my saved trials
2241
mi
from 91732
Hagerstown, MD
Click here to add this to my saved trials
2487
mi
from 91732
Hamden, CT
Click here to add this to my saved trials
2295
mi
from 91732
Hershey, PA
Click here to add this to my saved trials
2069
mi
from 91732
Hickory, NC
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92646
28
mi
from 91732
Huntington Beach, CA
Click here to add this to my saved trials
1785
mi
from 91732
Huntsville, AL
Click here to add this to my saved trials
2163
mi
from 91732
Indiana, PA
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
1546
mi
from 91732
Jonesboro, AR
Click here to add this to my saved trials
1840
mi
from 91732
Kalamazoo, MI
Click here to add this to my saved trials
994
mi
from 91732
Kalispell, MT
Click here to add this to my saved trials
840
mi
from 91732
Kennewick, WA
Click here to add this to my saved trials
99
mi
from 91732
La Jolla, CA
Click here to add this to my saved trials
1894
mi
from 91732
Lansing, MI
Click here to add this to my saved trials
660
mi
from 91732
Las Cruces, NM
Click here to add this to my saved trials
208
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
208
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
2515
mi
from 91732
Lebanon, NH
Click here to add this to my saved trials
2354
mi
from 91732
Limerick, PA
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
19
mi
from 91732
Los Alamitos, CA
Click here to add this to my saved trials
1586
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
664
mi
from 91732
Meridian, ID
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
1511
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
1302
mi
from 91732
Minot, ND
Click here to add this to my saved trials
Mission Viejo, California 92691
37
mi
from 91732
Mission Viejo, CA
Click here to add this to my saved trials
1495
mi
from 91732
Monroe, LA
Click here to add this to my saved trials
58
mi
from 91732
Murrieta, CA
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
2234
mi
from 91732
Myrtle Beach, SC
Click here to add this to my saved trials
2556
mi
from 91732
Nashua, NH
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
North Massapequa, New York 11758
2461
mi
from 91732
North Massapequa, NY
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
2201
mi
from 91732
Olean, NY
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
2130
mi
from 91732
Orange Park, FL
Click here to add this to my saved trials
1741
mi
from 91732
Owensboro, KY
Click here to add this to my saved trials
2118
mi
from 91732
Palm Habor, FL
Click here to add this to my saved trials
349
mi
from 91732
Paradise Valley, AZ
Click here to add this to my saved trials
1810
mi
from 91732
Pensacola, FL
Click here to add this to my saved trials
333
mi
from 91732
Peoria, AZ
Click here to add this to my saved trials
1618
mi
from 91732
Peoria, IL
Click here to add this to my saved trials
2368
mi
from 91732
Perkasie, PA
Click here to add this to my saved trials
1905
mi
from 91732
Petoskey, MI
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials