Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

Completed · Not applicable

Conditions studied: Rheumatoid Arthritis

In brief

This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.

Key facts

Study ID

NCT01643928

Run by

Pfizer

People needed

185

Starts

2012-08-16

Expected to finish

2016-03-14

Last updated by the study team

2019-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• 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.

You may not qualify if…

• Investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
• 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.

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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