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

Completed · Phase 1 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus, Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT03334851

Run by

Pfizer

People needed

74

Starts

2017-11-17

Expected to finish

2022-02-15

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• Wallace Rheumatic Studies Center — Beverly Hills, California, United States
• Prive aftercare — Los Angeles, California, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Private Practice of Robert W. Levin, MD — Clearwater, Florida, United States
• Avail Clinical Research — DeLand, Florida, United States
• Omega Research Maitland, LLC — Orlando, Florida, United States
• Larkin Hospital — South Miami, Florida, United States
• Qps Mra, Llc — South Miami, Florida, United States
• Qps-Mra, Llc — South Miami, Florida, United States
• PAREXEL International - EPCU Baltimore — Baltimore, Maryland, United States
• Rheumatology Express — Catonsville, Maryland, United States
• Carolina Phase 1 Research, LLC — Raleigh, North Carolina, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• MPP Infusion Centers — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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