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NCT01211678 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Biogen.

Completed
Registry status
301
Enrollment target

NCT01211678: Completed study, sponsored by Biogen.

NCT01211678 is a clinical trial that has completed, run by Biogen. The registered enrollment target is 301 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01211678 has completed, sponsored by Biogen.

COMPLETED
Registry status
301 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 301 participants
Start Date 2010-06
Est. Completion 2013-07
Biogen

334 total trials

What the finished NCT01211678 record still lists

NCT01211678 is an observational study that tracks outcomes without assigning an intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01211678 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01211678 about?

NCT01211678 is a clinical study titled "Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive Patients". 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 (...

What is the current status of trial NCT01211678?

This trial is currently completed. The enrollment target is 301 participants. The study started on 2010-06. Estimated completion is 2013-07.

Who is sponsoring clinical trial NCT01211678?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01211678, the US trial registry maintained by the National Library of Medicine. NCT01211678 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.