Design of a phase IV randomised, double-blind, placebo-controlled trial assessing the ImP act of R esidual Inflammation Detected via Imaging TE chniques, D rug Levels and Patient Characteristics on the Outcome of Dose TaperI ng of Adalimumab in C linical Remission Rheumatoid ArT hritis (RA ) patients (PREDICTRA)

BMJ Open
Paul EmeryPhilip G Conaghan

Abstract

The current American College of Rheumatology and European League Against Rheumatism treatment recommendations advise tapering biological disease-modifying antirheumatic drug (bDMARD) therapy in patients with rheumatoid arthritis (RA) who achieve stable clinical remission while receiving bDMARDs. However, not all patients maintain remission or low disease activity after tapering or discontinuation of bDMARDs. The aim of the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) study, or PREDICTRA, is to generate data on patient and disease characteristics that may predict the clinical course of a fixed dose-tapering regimen with the bDMARD adalimumab. PREDICTRA is an ongoing, multicentre, phase IV, randomised, double-blind, parallel-group study of adalimumab dose tapering controlled by withdrawal in participants with RA who achieved stable clinical remission while receiving adalimumab. The study includes a screening period, a 4-week lead-in period with open-label adalimumab 40 mg every other week and a subsequent 36-week double-blind period during which participants are randomised 5:1 t...Continue Reading

References

Oct 31, 2009·Arthritis and Rheumatism·Frederick Wolfe, Kaleb Michaud
Jul 20, 2012·Oman Medical Journal·Firdous JahanRizwan Qasim
Oct 10, 2012·Arthritis Research & Therapy·Fiona M McQueen
Mar 29, 2014·Postgraduate Medical Journal·Fiona M McQueen
Nov 6, 2014·The New England Journal of Medicine·Paul EmeryBonnie Vlahos
Apr 16, 2015·Annals of the Rheumatic Diseases·Ronald F van VollenhovenKarin Franck-Larsson
May 15, 2015·Annals of the Rheumatic Diseases·Josef S SmolenDesirée van der Heijde

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Methods Mentioned

BETA
imaging techniques

Clinical Trials Mentioned

NCT02198651

Software Mentioned

PREDICTRA
SAS
OPTIMA

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