A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)



Status:Completed
Conditions:Neurology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Neurology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:November 20, 2015
End Date:February 4, 2019

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

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis

This study will assess the efficacy and safety of tocilizumab compared with placebo in
participants with SSc across approximately 120 planned global study sites. The study will
consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week
open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind
treatment with active tocilizumab or matching placebo. In the open-label period, eligible
participants from either arm may receive active tocilizumab.


Inclusion Criteria:

- Diagnosis of SSc according to American College of Rheumatology (ACR) and European
League Against Rheumatism (EULAR) criteria, meeting criteria for active disease and
with total disease duration of less than or equal to (
- mRSS of 10-35 units, inclusive

- Agreement to remain abstinent or use an effective contraceptive method among males and
females with childbearing potential

Exclusion Criteria:

- Pregnant or lactating females

- Major surgery within 8 weeks prior to screening

- Scleroderma limited to the face or areas distal to the elbows or knees

- Rheumatic autoimmune disease other than SSc

- Immunization with a live or attenuated vaccine within 4 weeks prior to Baseline

- Known hypersensitivity to human, humanized, or murine monoclonal antibodies

- Moderately severe nervous system, renal, endocrine, pulmonary, cardiovascular, or
gastrointestinal (GI) disease not related to SSc, including diverticulitis or
ulcerative lower GI disorders, or myocardial infarction (MI) within 6 months prior to
screening

- Active or significant history of infection, including treatment with intravenous (IV)
antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to screening

- Significant history of tuberculosis (TB)

- Primary or secondary immunodeficiency

- Malignant disease, with the exception of excised/cured local basal or squamous cell
carcinoma of the skin or carcinoma in situ of the uterine cervix

- History of drug or alcohol abuse
We found this trial at
22
sites
Albany, New York 12203
?
mi
from
Albany, NY
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
1050 Northwest 15th Street
Boca Raton, Florida 33486
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
One Boston Medical Center Place
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
725 Uruguay
Buenos Aires, C1015ABO
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
El Cajon, California 92020
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
1847 Sunny Crest Drive
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Grand Rapids, Michigan 49546
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
6410 Fannin Street
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jackson, Tennessee 38305
?
mi
from
Jackson, TN
Click here to add this to my saved trials
1000 Veteran Avenue
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90045
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Ormond Beach, Florida
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
32615 US Highway 19 North
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
130 South 9th Street
Philadelphia, Pennsylvania 19131
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1221 Madison Street
Seattle, Washington 98104
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
3800 Reservoir Road Northwest
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials
Wyomissing, Pennsylvania 19610
?
mi
from
Wyomissing, PA
Click here to add this to my saved trials