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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: Completed Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by Pfizer.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLT was defined as any of the following events meeting the criteria: (1) \>=2 participants within a dose cohort developed Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 3 adverse event considered to be serious in the same organ system or 1 participant developed a CTCAE v4.0 Grade 4 or higher SAE considered related to study drug; (2) 50% or more participants within a dose cohort experienced a CTCAE v4.0 Grade 3 or higher infusion reaction; (3) a confirmed or probable case of Pr
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2017-11-17 |
| Est. Completion | 2022-02-15 |
| Phase | Phase 1 |
What the finished NCT03334851 record still lists
NCT03334851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower).
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 lists 17 locations in 7 states (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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Where NCT03334851's enrollment target sits among peer trials
74 130th of 197 higher than 67 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
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