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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor: Tufts Medical Center
Study ID: NCT06016517
Status: Not Yet Recruiting

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Conditions

Arthritis, Rheumatoid

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Etanercept — DRUG
50 mg subcutaneously weekly
Adalimumab — DRUG
40 mg subcutaneously every 2 weeks
Upadacitinib — DRUG
15 mg orally once daily with subcutaneous placebo injection every 2 weeks
Tocilizumab — DRUG
162 mg administered SQ every 2 weeks

Study Details

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).