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

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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
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Rochester, New York 14623
1120
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Rochester, NY
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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687
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Birmingham, AL
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
801
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
1038
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Chapel Hill, NC
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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...
1168
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4820 Park Blvd N.
Pinellas Park, Florida 33781
1111
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Albuquerque, New Mexico
523
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Albuquerque, NM
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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...
808
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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...
808
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Anniston, Alabama 36207
728
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Anniston, Alabama 36207
732
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Atlanta, Georgia 30303
801
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Baltimore, Maryland 21287
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1148
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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1444
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Boston, MA
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1287
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1043
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Chapel Hill, NC
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Charleston, South Carolina 29406
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Charlotte, North Carolina 28204
958
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Charlotte, North Carolina 00000
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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...
609
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Clarksburg, West Virginia 26301
949
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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...
898
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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...
349
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Daytona Beach, Florida 32114
1130
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841
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Detroit, MI
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Fair Oaks, California 95628
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Gainesville, Florida 32607
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Gainesville, Florida 32607
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Granger, Indiana 46530
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571
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569
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Indianapolis, Indiana 46202
643
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Indianapolis, Indiana 46202
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Jackson, Tennessee 38305
518
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Jackson, Tennessee 38305
520
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La Plata, Buenos Aires
5633
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Lakewood, California 90712
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960
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Long Beach, California 90813
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Long Beach, California 90813
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Los Angeles, California 90048
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Los Angeles, California 90095
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Los Angeles, California 90095
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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...
1178
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1303
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Manhasset, NY
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Meridian, Idaho
1050
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Mesquite, Texas 75150
346
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Miami, Florida 33175
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Middleburg Heights, Ohio 44130
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New York, New York 10016
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Oklahoma City, Oklahoma 73104
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Orlando, Florida 32804
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Ormond Beach, Florida 32174
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Palm Harbor, Florida 34684
1098
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29200 Harper Avenue
Saint Clair Shores, Michigan 48081
852
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Seattle, Washington 98133
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Tacoma, Washington 98405
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Tampa, Florida 33614
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1135
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Wyomissing, Pennsylvania 19610
1182
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