Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
NCT ID: NCT01643928
Last Updated: 2019-01-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
185 participants
INTERVENTIONAL
2012-08-16
2016-03-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis
NCT00443651
Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)
NCT02093026
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)
NCT01526057
Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
NCT03025308
A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
NCT00282308
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rituximab-Pfizer
Rituximab-Pfizer (PF-05280586) x 3 courses
1000 mg intravenous infusion \[IV\] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
Rituximab-EU+Rituximab-Pfizer
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.
Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Rituximab-US+Rituximab-Pfizer
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.
Rituximab-US + Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rituximab-Pfizer (PF-05280586) x 3 courses
1000 mg intravenous infusion \[IV\] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Rituximab-US + Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.
Exclusion Criteria
* Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Arthrocare, Arthritiscare & Research, PC
Gilbert, Arizona, United States
CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas, United States
UCLA Clinical & Translational Research Center
Los Angeles, California, United States
UCLA David Geffen School of Medicine
Los Angeles, California, United States
Desert Medical Advances
Palm Desert, California, United States
New England Research Associates, LLC
Trumbull, Connecticut, United States
QPS Labs
Newark, Delaware, United States
University of South Florida - College of Medicine Carol and Frank Morsani Center
Tampa, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
Illnois Bone & Joint Institute
Morton Grove, Illinois, United States
Covance Central Laboratory Services
Indianapolis, Indiana, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, United States
Klein & Associates, M.D., P.A.
Cumberland, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Bronson Internal Medicine and Rheumatology
Battle Creek, Michigan, United States
Justus J. Fiechtner, MD, PC
Lansing, Michigan, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, United States
North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical
Great Neck, New York, United States
PMG Research of Hickory LLC
Hickory, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
The Arthritis Group
Philadelphia, Pennsylvania, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, United States
Arthritis Associates, PLLC
Hixson, Tennessee, United States
Arthritis Clinic
Jackson, Tennessee, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Apocell, Inc
Houston, Texas, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, United States
Rheumatology Research Unit
Maroochydore, Queensland, Australia
Pharmacie Matte et Petit
Québec, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada
Clinique Medicale du Phare (ECG Only)
Rimouski, Quebec, Canada
Centre de Rhumatologie de l'Est du Quebec
Rimouski, Quebec, Canada
Clínica Medellín S.A. Sede Centro
Medellín, Antioquia, Colombia
IPS Rodrigo Botero S.A.S.
Medellín, Antioquia, Colombia
Mix Supplier S.A.
Medellín, Antioquia, Colombia
Rodrigo Botero S.A.S.
Medellín, Antioquia, Colombia
Centro de Reumatologia y Ortopedia
Barranquilla, Atlántico, Colombia
Clinica de La Costa Ltda.
Barranquilla, Atlántico, Colombia
Congregación de las Hermanas Franciscanas Misioneras de María Auxiliadora-Clinica La Asuncion
Barranquilla, Atlántico, Colombia
IPS Centro Integral de Reumatologia del Caribe, CIRCARIBE S.A.S.
Barranquilla, Atlántico, Colombia
IPS Centro Integral De Reumatologia del Caribe, CIRCARIBE S.A.S
Barranquilla, Atlántico, Colombia
Organizacion Clinica General Del Norte S.A.
Barranquilla, Atlántico, Colombia
Schlosspark-Klinik GmbH, Internal Medicine II
Berlin, , Germany
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Hospital Bernardette (Emergencies)
Guadalajara, Jalisco, Mexico
Private Office
Guadalajara, Jalisco, Mexico
C.T. Scanner de Mexico, S.A. de C.V. (CT ONLY)
Mexico City, Mexico City, Mexico
CLIDITER, S.A de C.V.
Mexico City, Mexico City, Mexico
Hospital Angeles Clinica Londres
Mexico City, Mexico City, Mexico
Hospital Angeles, Centro Medico del Potosi
San Luis Potosí City, , Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
San Luis Potosí City, , Mexico
LLC Scientific and Research Medical Complex "Your Health"
Kazan', Tatarstan Republic, Russia
State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans"
Kemerovo, , Russia
LLC Consulting and Diagnostic Rheumatological Center "Healthy Joints"
Novosibirsk, , Russia
St. Petersburg State Healthcare Institution "Clinical Rheumatology Hospital 25"
Saint Petersburg, , Russia
"AVA-PETER" Ltd - Affiliate Address
Saint Petersburg, , Russia
AVA-PETER Ltd.
Saint Petersburg, , Russia
Local Ethics Committee of LLC AVA-PETER
Saint Petersburg, , Russia
Laboratory of LLC AVA-PETER
Saint Petersburg, , Russia
State Budget Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin
Samara, , Russia
State Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin"
Samara, , Russia
Panorama Medical Centre - Room 136
Cape Town, , South Africa
Dr. Jan Fourie Medical Centre
KwaZulu Natal, , South Africa
Division of Rheumatic & Musculoskeletal Diseases
Leeds, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cohen SB, Burgos-Vargas R, Emery P, Jin B, Cronenberger C, Vazquez-Abad MD. Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1598-1606. doi: 10.1002/acr.23586.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ICON 9002/0101
Identifier Type: -
Identifier Source: secondary_id
2012-003223-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B3281004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.