Status:
COMPLETED
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
Lead Sponsor:
Pfizer
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 (S...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01405196
Start Date
December 1 2011
End Date
March 1 2014
Last Update
December 19 2017
Active Locations (113)
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1
Anniston Medical Clinic, PC
Anniston, Alabama, United States, 36207
2
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
3
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
4
Med Investigations, Inc.
Fair Oaks, California, United States, 95628