Status:
COMPLETED
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
Lead Sponsor:
Pfizer
Conditions:
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 des...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03334851
Start Date
November 17 2017
End Date
February 15 2022
Last Update
October 30 2023
Active Locations (17)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36201
2
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
3
Wallace Rheumatic Studies Center
Beverly Hills, California, United States, 90211
4
Prive aftercare
Los Angeles, California, United States, 90048