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)
Public ClinicalTrials.gov record NCT01526057. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01526057
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 220 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 20, 2012 (Actual)
- Primary completion
- Aug 13, 2013 (Actual)
- Completion
- May 7, 2014 (Actual)
- Last update posted
- Nov 19, 2019
2012 – 2014
United States locations
- U.S. sites
- 43
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Bermingham | Birmingham | Alabama | 35249 | — |
| University of Alabama at Birmingham - Arthritis Clinical Intervention Program (ACIP) SRC 076 | Birmingham | Alabama | 35294 | — |
| Rheumatology Associates of North Alabama, PC | Huntsville | Alabama | 35801 | — |
| ArthroCare, Arthritis Care & Research, PC | Gilbert | Arizona | 85234 | — |
| Mercy Clinic Hot Springs Communities | Hot Springs | Arkansas | 71913 | — |
| UCLA David Geffen School of Medicine | Los Angeles | California | 90095-1670 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | — |
| Desert Medical Advances | Palm Desert | California | 92260 | — |
| Advances In Medicine | Rancho Mirage | California | 92270 | — |
| New England Research Assoc. LLC | Trumbull | Connecticut | 06611 | — |
| Arthritis Associates | Orlando | Florida | 32804 | — |
| University of South Florida - College of Medicine, Frank and Carol Morsani Center | Tampa | Florida | 33612 | — |
| Loyola Center for Health at Burr Ridge | Burr Ridge | Illinois | 60527 | — |
| Loyola Medical Medical Center Outpatient Center | Maywood | Illinois | 60153 | — |
| Loyola University Medical Center Pharmacy | Maywood | Illinois | 60153 | — |
| Illinois Bone and Joint Institute | Morton Grove | Illinois | 60053 | — |
| Loyola Center for health at Oakbrook Terrace North | Oakbrook Terrace | Illinois | 60181 | — |
| Bluegrass Community Research, Inc. | Lexington | Kentucky | 40504 | — |
| Klein & Associates, M.D., P.A. | Cumberland | Maryland | 21502 | — |
| Klein & Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | — |
| UMass Memorial Medical Center - Memorial Campus | Worcester | Massachusetts | 01605 | — |
| UMass Memorial Medical Center-Rheumatology Center-Memorial Campus | Worcester | Massachusetts | 01605 | — |
| Bronson Internal Medicine & Rheumatology | Battle Creek | Michigan | 49015 | — |
| Rheumatology/Arthritis Center | Lansing | Michigan | 48910 | — |
| University Of Nevada School Of Medicine | Las Vegas | Nevada | 89102 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical Immunology | Great Neck | New York | 11021 | — |
| Box Arthritis & Rheumatology of the Carolinas, PLLC | Charlotte | North Carolina | 28210 | — |
| Hickory Family Practice Associates | Hickory | North Carolina | 28601 | — |
| PMG Research of Hickory, LLC - PI's Main Office (Subject visit, IP Storage, Infusion, & Lab Draws) | Hickory | North Carolina | 28602 | — |
| PMG Research of Hickory | Hickory | North Carolina | 28602 | — |
| Cincinnati Rheumatic Disease Study Group, Inc. | Cincinnati | Ohio | 45219 | — |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | 73103 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| The Arthritis Group | Philadelphia | Pennsylvania | 19152 | — |
| Clinical Research Center of Reading, LLP | Wyomissing | Pennsylvania | 19610 | — |
| Arthritis Associates, PLLC | Hixson | Tennessee | 37343 | — |
| Arthritis Clinic | Jackson | Tennessee | 38305 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | — |
| Center For Clinical Trials Of Houston | Houston | Texas | 77004 | — |
| Southwest Rheumatology Research LLC. | Mesquite | Texas | 75150 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01526057, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 19, 2019 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01526057 live on ClinicalTrials.gov.