Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
Tufts Medical Center
Summary
The goal of this N-of-1 study is to learn about treatment for individual patients who have rheumatoid arthritis (RA,) for which many treatments are available. The treatments are different in how they work, the way they are given, side- effects, and cost. While treatment guidelines are available, finding the best treatment order of treatments is often based on physician choice. The main question this study aims to answer are: * What are the effects of different treatments on RA symptoms and condition for each individual patient * What is the effectiveness of different treatments across all patients enrolled in the N-of-1 study Participants will be enrolled and randomized to a sequence of three U.S. Food and Drug Administration (FDA) approved RA medications: 1. etanercept, 2. adalimumab, 3. upadacitinib 4. tocilizumab. Participants will be asked to complete questionnaires about their condition and quality of life fortnightly, monthly and/or quarterly (either in clinic or remotely) and report their level of pain on alternate days (remotely).
Description
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 a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
In order to be eligible to participate in this study, a subject must meet all the following criteria: * Newly diagnosed adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2021 Criteria for the Classification of RA * Moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints * C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥ 1 time the upper limit of normal * First-line therapy with MTX for at least the 12 weeks…
Interventions
- DrugEtanercept
50 mg subcutaneously weekly
- DrugAdalimumab
40 mg subcutaneously every 2 weeks
- DrugUpadacitinib
15 mg orally once daily with subcutaneous placebo injection every 2 weeks
- DrugTocilizumab
162 mg administered SQ every 2 weeks
Location
- Tufts Medical CenterBoston, Massachusetts