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NCT03334851 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
74
Enrollment target
17
Study locations

NCT03334851 is a Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus that has completed, run by Pfizer. The registered enrollment target is 74 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower). The trial reports 17 study locations across 7 states.

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The verdict

NCT03334851, a Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
74 participants
Enrollment target
17
Study locations

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG PF-06835375

Study Locations (17)

Florida

  • Clinical Research of West Florida, Inc. - Clearwater
  • Private Practice of Robert W. Levin, MD - Clearwater
  • Avail Clinical Research - DeLand
  • Omega Research Maitland, LLC - Orlando
  • Larkin Hospital - South Miami
  • Qps Mra, Llc - South Miami
  • Qps-Mra, Llc - South Miami

Alabama

  • Pinnacle Research Group, LLC - Anniston
  • Pinnacle Research Group, LLC - Anniston

California

  • Wallace Rheumatic Studies Center - Beverly Hills
  • Prive aftercare - Los Angeles

Maryland

  • PAREXEL International - EPCU Baltimore - Baltimore
  • Rheumatology Express - Catonsville

Texas

  • Metroplex Clinical Research Center - Dallas
  • MPP Infusion Centers - Dallas

North Carolina

  • Carolina Phase 1 Research, LLC - Raleigh

Pennsylvania

  • Altoona Center for Clinical Research - Duncansville

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2017-11-17
Est. Completion 2022-02-15
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT03334851

The ClinicalTrials.gov registry entry for NCT03334851 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03334851 reports 17 study locations spanning 7 distinct geographic areas - top geographies include Florida, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT03334851 about?

NCT03334851 is a clinical study titled "Safety and Tolerability Study 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 ...

What is the current status of trial NCT03334851?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2017-11-17. Estimated completion is 2022-02-15.

What conditions does trial NCT03334851 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis, Systemic Lupus Erythematosus.

What interventions are being tested in trial NCT03334851?

The interventions under investigation include: Placebo (DRUG), PF-06835375 (DRUG).

Who is sponsoring clinical trial NCT03334851?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03334851 being conducted?

This trial has 17 study locations across Alabama, California, Florida, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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