Status:
COMPLETED
A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or Mab...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of rheumatoid arthritis
- Meets Class I, II or III of the ACR 1991 Revised Criteria
- RA seropositivity
- Stable dose of methotrexate
- Inadequate response to TNF inhibitors
Exclusion
- Any prior treatment with lymphocyte depleting therapies
- History of active TB infection
- Known or screen test positive for specific viruses or indicators of viral infection
Key Trial Info
Start Date :
March 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2014
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01526057
Start Date
March 20 2012
End Date
May 7 2014
Last Update
November 19 2019
Active Locations (84)
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1
University of Alabama at Bermingham
Birmingham, Alabama, United States, 35249
2
University of Alabama at Birmingham - Arthritis Clinical Intervention Program (ACIP) SRC 076
Birmingham, Alabama, United States, 35294
3
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States, 35801
4
ArthroCare, Arthritis Care & Research, PC
Gilbert, Arizona, United States, 85234