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).
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
None
Outpatients 18 years of age or older with newly diagnosed RA following initial treatment with MTX, to which they are partial responders or non-responders.
Other
Prospective
Etanercept
Drug50 mg subcutaneously weekly
Adalimumab
Drug40 mg subcutaneously every 2 weeks
Upadacitinib
Drug15 mg orally once daily with subcutaneous placebo injection every 2 weeks
Tocilizumab
Drug162 mg administered SQ every 2 weeks
Change in Disease Activity Score (DAS) 28
Evaluates patient and physician overall assessment of disease activity, including the number of swollen and painful joints (out of 28 joints),
Change in The Routine Assessment of Patient Index Data 3 (RAPID3)
Assessment of a) function, b) pain, and c) patient global estimate of status
Change in American College of Rheumatology 20 (ACR20)
≥20% fewer tender and swollen joints and ≥20% improvement in three of five other domains; a) patient global assessment, b) physician global assessment, c) functional questionnaire, d) pain score, and f) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
Change in American College of Rheumatology 50 (ACR50)
≥50% fewer tender and swollen joints and ≥20% improvement in three of five other domains; a) patient global assessment, b) physician global assessment, c) functional questionnaire, d) pain score, and f) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
Change in American College of Rheumatology 70 (ACR70)
≥70% fewer tender and swollen joints and ≥20% improvement in three of five other domains; a) patient global assessment, b) physician global assessment, c) functional questionnaire, d) pain score, and f) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
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This trial is not recruiting at the moment. You can still explore other options:
