Proactive infliximab optimisation using a pharmacokinetic dashboard versus standard of care in patients with Crohn’s disease: study protocol for a randomised, controlled, multicentre, open-label study (the OPTIMIZE trial)

• Vipul Jairath,
• Guangyong Zou,
• Niels Vande Casteele,
• Michelle Smith,
• Marla Dubinsky,
• Konstantinos Papamichael,
• Bruce Sands,
• John Valentine,
• Corey Siegel,
• Benjamin Cohen,
• Timothy Ritter,
• Adam Cheifetz

Affiliations

Vipul Jairath

18 Alimentiv, Inc (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada

Guangyong Zou

Department of Biostatistics and Epidemiology, Western University, London, Ontario, Canada

Niels Vande Casteele

Department of Medicine, University of California San Diego, La Jolla, California, USA

Michelle Smith

4Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, Queensland, Australia

Marla Dubinsky

7 Department of Pediatrics, Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, Mount Sinai, New York, USA

Konstantinos Papamichael

Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA

Bruce Sands

4 Icahn School of Medicine at Mount Sinai, New York, New York, USA

John Valentine

Division of Gastroenterology, University of Utah School of Medicine, Salt Lake City, Utah, USA

Corey Siegel

Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA

Benjamin Cohen

Department of Gastroenterology, Hepatology & Nutrition, Cleveland Clinic, Cleveland, Ohio, USA

Timothy Ritter

GI Alliance, Southlake, Texas, USA

Adam Cheifetz

Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA