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 |
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.
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
15
sites
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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