A Pragmatic Registry-Based Randomized Trial of Drug Tapering in Rheumatoid Arthritis
Study Start Date:
April 2018
End Date:
July 2024
Why Do This Research?
Rheumatoid arthritis is a chronic autoimmune disease that affects up to 1% of the adult population and causes fatigue, joint pain, swelling and a reduced quality of life. Fortunately, the treatment for rheumatoid arthritis has advanced, and most patients can now have their disease effectively controlled with medications. After a patient’s disease has been successfully treated and controlled, the usual practice is to continue with these medications for life. Emerging evidence suggests some patients may be able to successfully reduce medication once their disease is under control, but this evidence has important limitations, and more clinical trials are needed.
What Will Be Done?
We will conduct a clinical trial to evaluate the effectiveness and safety of a patient-centered approach for treatment reduction in patients with rheumatoid arthritis. The study will be embedded within an ongoing national study of over 2000 patients with rheumatoid arthritis
We will identify patients whose disease has been well controlled for at least 6 months and ask if they would like to participate. Interested patients will be randomized to either usual care or a structured but flexible approach to reduce treatment in a shared decision with their physician. Treatment outcomes, including both benefits (ability to successfully reduce treatment) and harms (disease flares) will be compared over 18 months. Alongside these outcomes, we will also measure patient preferences for the benefits and harms, and other outcomes to evaluate the impact on healthcare costs. The data generated will provide real-world data on a patient-centered approach to treatment reduction in patients with rheumatoid arthritis, a common chronic disease with high drug costs.
Who Is Involved?
The study will be embedded within an ongoing national study of over 2000 patients with rheumatoid arthritis.
How do people get involved?
If you would more information, please contact: Pauline Hull pauline.hull@ucalgary.ca
Research Team
Principal Investigator:
Glen Hazlewood, MD, PhD, FRCPC, Research Scientist, Rheumatology, Arthritis Research Canada (University of Calgary)
Co-Investigators:
Nick Bansback, MSc, PhD, Research Scientist, Health Economics, Arthritis Research Canada (University of British Columbia)
Claire Barber, MD, PhD, FRCPC, Research Scientist, Rheumatology, Arthritis Research Canada (University of Calgary)
Susan Bartlett, Research Scientist, Licensed Psychologist, Arthritis Research Canada (McGill University)
Gilles Boire, MD, MSc – Professor, Department of Medicine, Division of Rheumatology, (Université de Sherbrooke)
Rob Deardon, MSc, PhD – Associate Professor (Biostatistics), (University of Calgary)
Edward Keystone, MD, FRCPC – Professor, Faculty of Medicine, (University of Toronto)
Deborah A. Marshall, PhD, Senior Scientist, Health Services Research and Health Economics, Arthritis Research Canada (University of Calgary)
Janet Pope, MD – Professor, Schulich School of Medicine, (Western University)
Laurie Proulx – Patient Collaborator, Member, Steering Committee, Canadian Arthritis Patient Alliance
Dawn Richards, PhD – Director of Patient and Public Engagement at Clinical Trials Ontario
Orit Schieir, MSc, PhD – Scientific Manager, Canadian Early Arthritis Cohort Study (CATCH)
Carter Thorne, MD, FRCP – Chief, Division of Rheumatology, Southlake Regional Health Centre
George Tomlinson, MSC, PhD – Associate Professor, Institute of Health Policy, Management and Evaluation, (University of Toronto)
Peter Tugwell, MD, FRCPC – Professor of Medicine and Epidemiology & Community Medicine at the (University of Ottawa)
Funding Agency:
Canadian Institutes of Health Research
