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Application of N-of-1 Clinical Trial Design in Rhematoid Arthritis

Application of the N-of-1 Trial Design Paradigm
Rheumatoid Arthritis Protocol

Rheumatoid arthritis
All genders
person-wave 18-65
Recruiting now


Principal Investigator: Harry Selker, MD

Rheumatoid arthritis (RA) is a chronic, slowly progressive condition for which numerous treatment options are available. The therapies vary in mechanism of action, mode of administration, side- effect (adverse event) profile, and cost. While consensus treatment guidelines are available, identifying an optimal treatment sequence is often based on clinician choice with treatment changes based on tolerability and short- term outcome. The N-of-1 trial will evaluate individual participant and aggregate data. Individual participants will be enrolled and randomized to a sequence of three U.S. Food and Drug Administration (FDA)-approved therapeutic agents – adalimumab, sarilumab, upadacitinib— plus matching placebos to enable blinding of patients, clinicians, and study personnel.

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Dorothy Dulko, PhD

Study details

Inclusion Criteria
  • 1. Newly diagnosed with moderate to severe RA
  • 2. First-line therapy with MTX for at least the 12 weeks prior to study entry with a continuous, non-changing dose for at least 8 weeks prior to study entry
  • 3. Had to discontinue MTX due to intolerability or toxicity, irrespective of treatment duration
Exclusion Criteria
  • 1. Is currently receiving corticosteroids at doses > (greater than) 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
  • 2. Has experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure
  • 3. Tuberculosis, Hepatitis B or C infection
Study Requirements

Individual participants will complete all visits within 36 weeks of enrollment; with a final telehealth visit at 30-days post study completion. Adverse events will be monitored and collected by the research team from the point of signed consent until Week 36; with a final adverse event assessment at the 30-day post study completion visit.

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