Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients

Completed

Conditions studied: Arthritis, Rheumatoid

In brief

The primary objective of this study was to validate the ability of an 8-gene biomarker set to differentiate between participants who met or did not meet European League Against Rheumatism (EULAR) Disease Activity Score (DAS)-28 Good Response criteria after treatment with anti-Tumor Necrosis Factor (TNF) therapy for 14 weeks in approximately 200 anti-TNF-naïve participants. The secondary objectives of this study was (i) to compare the behavior of the 8-gene marker set in participants who were anti-TNF naïve versus those who began their second anti-TNF treatment , (ii) to develop, maintain, and utilize a biorepository of serum, plasma, RNA, and deoxyribonucleic acid (DNA) samples for additional experiments and analyses and (iii) to discover novel genetic (DNA) predictors of response to anti-TNF therapy.

Key facts

Study ID

NCT01211678

Run by

Biogen

People needed

301

Starts

2010-06-01

Expected to finish

2013-07-01

Last updated by the study team

2014-06-09

Who can join

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

Where it is running

• Research Site — Murrieta, California, United States
• Research Site — Longmont, Colorado, United States
• Research Site — Lewes, Delaware, United States
• Research Site — Dunedin, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Orange Park, Florida, United States
• Research Site — Morton Grove, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Plymouth, Massachusetts, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Reno, Nevada, United States
• Research Site — Berkeley Heights, New Jersey, United States
• Research Site — Summit, New Jersey, United States
• Research Site — Floral Park, New York, United States
• Research Site — Orchard Park, New York, United States
• Research Site — Smithtown, New York, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Wilmington, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Mayfield Village, Ohio, United States
• Research Site — Middleburg Heights, Ohio, United States
• Research Site — Edmund, Oklahoma, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Mrytle Beach, South Carolina, United States
• Research Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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