Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis



Status:Recruiting
Conditions:Arthritis, Lupus, Rheumatoid Arthritis
Therapuetic Areas:Immunology / Infectious Diseases, Rheumatology
Healthy:No
Age Range:18 - 70
Updated:3/27/2019
Start Date:November 17, 2017
End Date:September 8, 2022
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS

This is a Phase 1 single and multiple dose escalation study to evaluate the safety,
tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with
seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This
study will include two parts: Part A and Part B. Part A will consist of single ascending dose
cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of
approximately 112 subjects at approximately 10 sites.


Inclusion Criteria:

- Patients with Rheumatoid Arthritis: confirmed diagnosis according to 2010 ACR/EULAR
criteria with symptom duration at least 6 months and positive with Rheumatoid Factor
and/or anti citrullinated peptide antibody

- Patients with Systemic Lupus Erythematosus: Confirmed diagnosis according to the SLICC
Classification Criteria with symptom duration at least 6 months and at least one of
the following: positive antinuclear antibody titer, positive anti-dsDNA, anti-Smith
antibodies

Exclusion Criteria:

- Active central nervous system manifestations, systemic vasculitis or
pleuro/pericarditis

- Active lupus nephritis

- Treatment with B cell depleting agents within 52 weeks prior to screening
We found this trial at
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8750 Wilshire Boulevard
Beverly Hills, California 90211
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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Anniston, Alabama 36207
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Baltimore, Maryland 21225
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Catonsville, Maryland 21228
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Clearwater, Florida 33765
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Duncansville, Pennsylvania 16635
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Glendale, California 91206
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Los Angeles, California 90048
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7912 Forest City Road
Orlando, Florida 32810
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3100 Duraleigh Road
Raleigh, North Carolina 27612
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South Miami, Florida 33143
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