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Open Access Highly Accessed Study protocol

A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial

Ruben Tavares1*, Karen Anne Beattie2, William George Bensen2, Raja S Bobba2, Alfred A Cividino2, Karen Finlay34, Ron Goeree56, Lawrence Errol Hart2, Erik Jurriaans34, Maggie J Larche2, Naveen Parasu34, Jean-Eric Tarride567, Colin E Webber8 and Jonathan D Adachi2

Author Affiliations

1 UNCOVER Clinical Research Company, Milton, ON, Canada

2 Department of Medicine, Division of Rheumatology, McMaster University, Hamilton, ON, Canada

3 Department of Diagnostic Imaging, Juravinski Hospital, Hamilton, ON, Canada

4 Department of Medicine, Division of Radiology, McMaster University, Hamilton, ON, Canada

5 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada

6 Programs for Assessment of Technology in Health (PATH) Research Institute, St Joseph’s Healthcare Hamilton, Hamilton, ON, Canada

7 Department of Economics, McMaster University, Hamilton, ON, Canada

8 Department of Nuclear Medicine, Hamilton Health Sciences, Hamilton, ON, Canada

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Trials 2014, 15:268  doi:10.1186/1745-6215-15-268

Published: 5 July 2014

Abstract

Background

Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6 months from symptom onset. Early, intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) can delay the onset and progression of joint damage. The primary objective of the study is to investigate the value of magnetic resonance imaging (MRI) or radiography (X-ray) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA.

Methods

A double-blind, randomized controlled trial has been designed. Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6 months. Baseline adaptive randomization will be used to allocate participants to MRI, X-ray, or sham-intervention groups on a background of standard of care. Prognostic markers, treating physician, and baseline DMARD therapy will be used as intervention allocation parameters. The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images, respectively. Radiologists will score anonymized images for all patients regardless of intervention allocation. Disease progression will be determined based on the study-specific, inter-rater smallest detectable difference. Allocation-dependent, intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist. Negative reports will be delivered for the sham-intervention group. Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care. DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective. A sample size of 186 (62 per group) patients will be required to determine a 36% difference in pharmacological treatment escalation between the three groups with intermediate dispersion of data with 90% power at a 5% level of significance.

Discussion

This study will determine if monitoring RA and undifferentiated inflammatory arthritis patients using MRI and X-ray every 6 months over 2 years provides incremental evidence over standard of care to influence pharmacotherapeutic decision-making and ultimately hinder disease progression.

Trial registration

This trial has been registered at ClinicalTrials.gov: NCT00808496 (registered on 12 December 2008).

Keywords:
Arthritis; Rheumatoid; Randomized control trial; Magnetic resonance imaging; Radiography; Antirheumatic agents; Disease management