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
Click here to add this to my saved trials
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials