Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:12/21/2017
Start Date:December 2011
End Date:March 2014

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

A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)

The objective of this study is to evaluate and compare efficacy of 3 dose levels of
PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic
Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory
measures as well.


Inclusion Criteria:

- Male or female subjects between ages of 18 and 75 years old at time of signing
consent.

- Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American
College of Rheumatology (ACR) criteria.

- Have a unequivocally positive anti-nuclear antibody (ANA) test result.

- Active disease at screening defined by both: SLEDAI-2K score greater than or equal to
6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or
central nervous system) or BILAG B disease in more than or equal to 2 organ systems if
no level A disease in present.

Exclusion Criteria:

- Any prior history of treatment with PF-04236921, or anti-IL-6 agent;

- Have received any of the following within 364 days of day 1: a biologic
investigational agent other than B cell targeted therapy; required 3 or more courses
of systemic corticosteroids for concomitant conditions; history of previously
untreated or current evidence of active or untreated latent infection with
Tuberculosis (TB), evidence of prior untreated or currently active TB by chest
radiography, residing with or frequent close contact with an individual with active
TB.
We found this trial at
67
sites
Jackson, Tennessee 38305
?
mi
from
Jackson, TN
Click here to add this to my saved trials
2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
4820 Park Blvd N.
Pinellas Park, Florida 33781
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
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
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Anniston, Alabama 36207
?
mi
from
Anniston, AL
Click here to add this to my saved trials
Anniston, Alabama 36207
?
mi
from
Anniston, AL
Click here to add this to my saved trials
Atlanta, Georgia 30303
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29406
?
mi
from
Charleston, SC
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
Charlotte, North Carolina 00000
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
?
mi
from
Clarksburg, WV
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Daytona Beach, Florida 32114
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Fair Oaks, California 95628
?
mi
from
Fair Oaks, CA
Click here to add this to my saved trials
Gainesville, Florida 32607
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Gainesville, Florida 32607
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Gainesville, Florida 32607
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Granger, Indiana 46530
?
mi
from
Granger, IN
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
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
La Plata, Buenos Aires
?
mi
from
La Plata,
Click here to add this to my saved trials
Lakewood, California 90712
?
mi
from
Lakewood, CA
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Meridian, Idaho
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Mesquite, Texas 75150
?
mi
from
Mesquite, TX
Click here to add this to my saved trials
Miami, Florida 33175
?
mi
from
Miami, FL
Click here to add this to my saved trials
Middleburg Heights, Ohio 44130
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32804
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Rochester, New York 14623
?
mi
from
Rochester, NY
Click here to add this to my saved trials
29200 Harper Avenue
Saint Clair Shores, Michigan 48081
?
mi
from
Saint Clair Shores, MI
Click here to add this to my saved trials
Seattle, Washington 98133
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tampa, Florida 33614
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Upland, CA
Click here to add this to my saved trials
?
mi
from
Upland, CA
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