Abstract | INTRODUCTION: METHODS AND ANALYSIS: 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 to adalimumab 40 mg every 3 weeks (taper arm) or placebo (withdrawal arm). The primary explanatory efficacy variables are lead-in baseline hand and wrist MRI-detected synovitis and bone marrow oedema scores, as well as a composite of both scores; the dependent variable is the occurrence of flare up to week 40. Additional efficacy variables, safety, pharmacokinetics, biomarkers and immunogenicity will also be assessed, and an ultrasound substudy will be conducted. ETHICS AND DISSEMINATION: The study is conducted in accordance with the International Conference on Harmonisation guidelines, local laws and the ethical principles of the Declaration of Helsinki. All participants are required to sign a written informed consent statement before the start of any study procedures. TRIAL REGISTRATION NUMBER: EudraCT 2014-001114-26 and NCT02198651; Pre-results.
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Authors | Paul Emery, Gerd R Burmester, Esperanza Naredo, Yijie Zhou, Maja Hojnik, Philip G Conaghan |
Journal | BMJ open
(BMJ Open)
Vol. 8
Issue 2
Pg. e019007
(02 28 2018)
ISSN: 2044-6055 [Electronic] England |
PMID | 29490959
(Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. |
Chemical References |
- Antirheumatic Agents
- Tumor Necrosis Factor-alpha
- Adalimumab
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Topics |
- Adalimumab
(administration & dosage, pharmacology)
- Antirheumatic Agents
(administration & dosage, pharmacology)
- Arthritis, Rheumatoid
(drug therapy)
- Double-Blind Method
- Humans
- Inflammation
(drug therapy)
- Regression Analysis
- Remission Induction
- Research Design
- Severity of Illness Index
- Tumor Necrosis Factor-alpha
(antagonists & inhibitors)
- United Kingdom
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