Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTufts Medical Center

About this trial

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).

Eligibility criteria

Qualifiers

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 prior to study entry with a continuous, non-changing dose for at least 8 weeks prior to study entry but continue to exhibit active RA

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Etanercept
  • Adalimumab
  • Upadacitinib
  • Tocilizumab

Treatment groups

No treatment groups listed

Sponsors and collaborators