A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2011
End Date:November 2013

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

A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the
reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in
combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients
with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study,
patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously
every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study,
patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from
Week 24 to Week 96 using a pre-filled syringe or an auto-injector.


Inclusion Criteria:

- Adult patients, ≥ years of age.

- Moderate to severe rheumatoid arthritis of ≥ 6 months duration.

- Receiving treatment on an outpatient basis.

- Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68
joint count) at screening and study start.

- On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior
to study start.

Exclusion Criteria:

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization.

- Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's
Syndrome with rheumatoid arthritis is allowed.

- Functional class IV as defined by the American College of Rheumatology (ACR)
Classification of Functional Status in Rheumatoid Arthritis.

- Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or
rheumatoid arthritis before the age of 16 years.

- Prior history of or current inflammatory joint disease other than rheumatoid
arthritis.

- History of malignancy, active or recurrent infections, positive to hepatitis B
surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to
biologics, or a history of diverticular disease or other symptomatic GI conditions
that might predispose to perforations.

Other inclusion and exclusion criteria applied to the study.
We found this trial at
41
sites
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Allentown, PA
Click here to add this to my saved trials
?
mi
from
Belmont, NC
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Crofton, MD
Click here to add this to my saved trials
?
mi
from
Dallas, TX
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
Flowood, MS
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Meridan, ID
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
Ormond Beach, FL
Click here to add this to my saved trials
?
mi
from
Peoria, AZ
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
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Springfield, IL
Click here to add this to my saved trials
?
mi
from
St Louis, MO
Click here to add this to my saved trials
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
?
mi
from
Trumbull, CT
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Vernon Hills, IL
Click here to add this to my saved trials
?
mi
from
West Hills, CA
Click here to add this to my saved trials
?
mi
from
Wexford, PA
Click here to add this to my saved trials
?
mi
from
Wheaton, MD
Click here to add this to my saved trials
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials