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
1725
mi
from 43215
Meridian, ID
Click here to add this to my saved trials
1333
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
1078
mi
from 43215
Amarillo, TX
Click here to add this to my saved trials
302
mi
from 43215
Asheville, NC
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
344
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
180
mi
from 43215
Beckley, WV
Click here to add this to my saved trials
Berkeley Heights, New Jersey 07922
455
mi
from 43215
Berkeley Heights, NJ
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
1714
mi
from 43215
Boise, ID
Click here to add this to my saved trials
1714
mi
from 43215
Boise, ID
Click here to add this to my saved trials
1714
mi
from 43215
Boise, ID
Click here to add this to my saved trials
276
mi
from 43215
Bowling Green, KY
Click here to add this to my saved trials
943
mi
from 43215
Boynton Beach, FL
Click here to add this to my saved trials
522
mi
from 43215
Bridgeport, CT
Click here to add this to my saved trials
478
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
478
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
5386
mi
from 43215
Buenos Aires,
Click here to add this to my saved trials
317
mi
from 43215
Burke, VA
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
150
mi
from 43215
Clarksburg, WV
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
1748
mi
from 43215
Coeur D'Alene, ID
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
1161
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
426
mi
from 43215
Columbia, SC
Click here to add this to my saved trials
6
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
6
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
995
mi
from 43215
Coral Gables, FL
Click here to add this to my saved trials
1174
mi
from 43215
Corpus Christi, TX
Click here to add this to my saved trials
1952
mi
from 43215
Covina, CA
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
749
mi
from 43215
Daytona Beach, FL
Click here to add this to my saved trials
416
mi
from 43215
Duluth, GA
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
243
mi
from 43215
Duncansville, PA
Click here to add this to my saved trials
354
mi
from 43215
Durham, NC
Click here to add this to my saved trials
616
mi
from 43215
Eagan, MN
Click here to add this to my saved trials
Fall River, Massachusetts 02720
631
mi
from 43215
Fall River, MA
Click here to add this to my saved trials
545
mi
from 43215
Farmington, CT
Click here to add this to my saved trials
213
mi
from 43215
Flint, MI
Click here to add this to my saved trials
660
mi
from 43215
Flowood, MS
Click here to add this to my saved trials
135
mi
from 43215
Fort Wayne, IN
Click here to add this to my saved trials
937
mi
from 43215
Fort Worth, TX
Click here to add this to my saved trials
1970
mi
from 43215
Glendale, AZ
Click here to add this to my saved trials
282
mi
from 43215
Hagerstown, MD
Click here to add this to my saved trials
539
mi
from 43215
Hamden, CT
Click here to add this to my saved trials
337
mi
from 43215
Hershey, PA
Click here to add this to my saved trials
304
mi
from 43215
Hickory, NC
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92646
1967
mi
from 43215
Huntington Beach, CA
Click here to add this to my saved trials
410
mi
from 43215
Huntsville, AL
Click here to add this to my saved trials
208
mi
from 43215
Indiana, PA
Click here to add this to my saved trials
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
668
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
506
mi
from 43215
Jonesboro, AR
Click here to add this to my saved trials
206
mi
from 43215
Kalamazoo, MI
Click here to add this to my saved trials
1640
mi
from 43215
Kalispell, MT
Click here to add this to my saved trials
1854
mi
from 43215
Kennewick, WA
Click here to add this to my saved trials
1926
mi
from 43215
La Jolla, CA
Click here to add this to my saved trials
206
mi
from 43215
Lansing, MI
Click here to add this to my saved trials
1421
mi
from 43215
Las Cruces, NM
Click here to add this to my saved trials
1767
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
1767
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
609
mi
from 43215
Lebanon, NH
Click here to add this to my saved trials
395
mi
from 43215
Limerick, PA
Click here to add this to my saved trials
622
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
1970
mi
from 43215
Los Alamitos, CA
Click here to add this to my saved trials
508
mi
from 43215
Memphis, TN
Click here to add this to my saved trials
902
mi
from 43215
Mesquite, TX
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
624
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
1066
mi
from 43215
Minot, ND
Click here to add this to my saved trials
Mission Viejo, California 92691
1953
mi
from 43215
Mission Viejo, CA
Click here to add this to my saved trials
721
mi
from 43215
Monroe, LA
Click here to add this to my saved trials
1930
mi
from 43215
Murrieta, CA
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
487
mi
from 43215
Myrtle Beach, SC
Click here to add this to my saved trials
629
mi
from 43215
Nashua, NH
Click here to add this to my saved trials
798
mi
from 43215
New Orleans, LA
Click here to add this to my saved trials
422
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
North Massapequa, New York 11758
505
mi
from 43215
North Massapequa, NY
Click here to add this to my saved trials
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
280
mi
from 43215
Olean, NY
Click here to add this to my saved trials
682
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
681
mi
from 43215
Orange Park, FL
Click here to add this to my saved trials
266
mi
from 43215
Owensboro, KY
Click here to add this to my saved trials
821
mi
from 43215
Palm Habor, FL
Click here to add this to my saved trials
1653
mi
from 43215
Paradise Valley, AZ
Click here to add this to my saved trials
695
mi
from 43215
Pensacola, FL
Click here to add this to my saved trials
1666
mi
from 43215
Peoria, AZ
Click here to add this to my saved trials
348
mi
from 43215
Peoria, IL
Click here to add this to my saved trials
410
mi
from 43215
Perkasie, PA
Click here to add this to my saved trials
385
mi
from 43215
Petoskey, MI
Click here to add this to my saved trials
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials