A pragmatic registry-based randomized trial of drug tapering in rheumatoid arthritis

 

Principal Investigator:  Glen Hazlewood, MD, PhD, FRCPC, Assistant Professor, Division of Rheumatology, Department of Medicine, Cumming School of Medicine, University of Calgary

Study Start Date:  April 2018         

Study End Date:  March 2021

 

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.

Co-investigators:

Nick Bansback, MSc, PhD – Associate Professor, School of Population and Public Health, University of British Columbia, Research Scientist, Arthritis Research Canada

Claire Barber, MD, PhD – Assistant Professor, Division of Rheumatology, Department of Medicine, Cumming School of Medicine, University of Calgary, Research Scientist, Arthritis Research Canada

Susan Bartlett, PhD – Associate Professor of Medicine, Divisions of Clinical Epidemiology, Rheumatology and Respiratory Medicine, McGill University, Research Scientist, Johns Hopkins Arthritis Center

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 Marshall, PhD, MHSA – Professor, Department of Community Health Sciences Faculty of Medicine, University of Calgary, Senior Research Scientist, Arthritis Research Canada

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

 

How do people get involved? If you would more information, please contact: Pauline Hull pauline.hull@ucalgary.ca