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

NCT03334851

CompletedPhase 1

Sponsor: Pfizer

Conditions: Systemic Lupus Erythematosus, Rheumatoid Arthritis

Interventions: PF-06835375, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (17)
  • Anniston, Alabama, United States
  • Anniston, Alabama, United States
  • Beverly Hills, California, United States
  • Los Angeles, California, United States
  • Clearwater, Florida, United States
  • Clearwater, Florida, United States
  • DeLand, Florida, United States
  • Orlando, Florida, United States
  • South Miami, Florida, United States
  • South Miami, Florida, United States
  • South Miami, Florida, United States
  • Baltimore, Maryland, United States
  • Catonsville, Maryland, United States
  • Raleigh, North Carolina, United States
  • Duncansville, Pennsylvania, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States