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 |
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.
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
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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733 North Broadway
Baltimore, Maryland 21205
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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Chapel Hill, North Carolina 27514
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Chapel Hill, North Carolina 27514
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Gainesville, Florida 32607
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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