Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab

Completed

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab.

Key facts

Study ID

NCT01981473

Run by

Pfizer

People needed

605

Starts

2014-01-01

Expected to finish

2014-12-01

Last updated by the study team

2016-01-12

Who can join

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

You may qualify if…

• Age 18 years or older.
• Diagnosis of RA based on the 1987 American College of Rheumatology revised criteria
• Current continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months.

You may not qualify if…

• Treatment with biosimilar or investigational etanercept, adalimumab, or infliximab within past 6 months.
• Treatment with any other investigational drugs within past 3 months or five half lives of the drug, whichever is longer.
• Any medical condition that would interfere with rheumatoid arthritis evaluation or other study assessments (eg, fibromyalgia, lupus).

Where it is running

• Arizona Arthritis & Rheumatology Associates, P. C. — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology — Phoenix, Arizona, United States
• Arizona Arthritis and Rheumatology Research, PLLC — Phoenix, Arizona, United States
• Arizona Arthritis & Rheumatology Research — Sun City, Arizona, United States
• Mercy Clinic Hot Springs Communities — Hot Springs, Arkansas, United States
• Sutter Institute for Medical Research — Sacramento, California, United States
• Arthritis Care Center, Incorporated — San Jose, California, United States
• Rheumatology Consultants of Delaware dba Delaware Arthritis — Lewes, Delaware, United States
• Omega Research Consultants, LLC — DeBary, Florida, United States
• Center for Rheumatology, Immunology, and Arthritis — Fort Lauderdale, Florida, United States
• Florida Medical Research — Gainesville, Florida, United States
• Arthritis and Rheumatic Care Center — South Miami, Florida, United States
• Health Point Medical Group, Inc. — Tampa, Florida, United States
• Northeast Georgia Diagnostic Clinic, LLC — Gainesville, Georgia, United States
• Via Christi Hospitals Wichita, Inc. — Wichita, Kansas, United States
• Rheumatology Associates of Baltimore — Baltimore, Maryland, United States
• Phase III Clinical Research — Fall River, Massachusetts, United States
• David S. Rosenberg, M.D — Florissant, Missouri, United States
• Dr Melvin Albert Churchill Jr — Lincoln, Nebraska, United States
• Prospect Medical Offices — Midland Park, New Jersey, United States
• Advanced Arthritis Care Center — Brooklyn, New York, United States
• Prem C.Chatpar, M.D., LLC — Plainview, New York, United States
• Box Arthritis and Rheumatology — Charlotte, North Carolina, United States
• Clinical Research Center of Reading, LLC — Wyomissing, Pennsylvania, United States
• Arizona Arthritis & Rheumatology — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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