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)
Completed · Phase 2
Conditions studied: Rheumatoid Arthritis
In brief
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 MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.
Key facts
- Study ID
- NCT01526057
- Run by
- Pfizer
- People needed
- 220
- Starts
- 2012-03-20
- Expected to finish
- 2014-05-07
- Last updated by the study team
- 2019-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham - Arthritis Clinical Intervention Program (ACIP) SRC 076 — Birmingham, Alabama, United States
- Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States
- ArthroCare, Arthritis Care & Research, PC — Gilbert, Arizona, United States
- Mercy Clinic Hot Springs Communities — Hot Springs, Arkansas, United States
- UCLA David Geffen School of Medicine — Los Angeles, California, United States
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
- Desert Medical Advances — Palm Desert, California, United States
- Advances In Medicine — Rancho Mirage, California, United States
- New England Research Assoc. LLC — Trumbull, Connecticut, United States
- Arthritis Associates — Orlando, Florida, United States
- University of South Florida - College of Medicine, Frank and Carol Morsani Center — Tampa, Florida, United States
- Loyola Center for Health at Burr Ridge — Burr Ridge, Illinois, United States
- Loyola Medical Medical Center Outpatient Center — Maywood, Illinois, United States
- Loyola University Medical Center Pharmacy — Maywood, Illinois, United States
- Illinois Bone and Joint Institute — Morton Grove, Illinois, United States
- Loyola Center for health at Oakbrook Terrace North — Oakbrook Terrace, Illinois, United States
- Bluegrass Community Research, Inc. — Lexington, Kentucky, United States
- Klein & Associates, M.D., P.A. — Cumberland, Maryland, United States
- Klein & Associates, M.D., P.A. — Hagerstown, Maryland, United States
- Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
- UMass Memorial Medical Center - Memorial Campus — Worcester, Massachusetts, United States
- UMass Memorial Medical Center-Rheumatology Center-Memorial Campus — Worcester, Massachusetts, United States
- Bronson Internal Medicine & Rheumatology — Battle Creek, Michigan, United States
- Rheumatology/Arthritis Center — Lansing, Michigan, United States
- University of Alabama at Bermingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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