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

NCT06016517 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2026-04-13

No results posted yet for this study

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).

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Etanercept

50 mg subcutaneously weekly

DRUG

Adalimumab

40 mg subcutaneously every 2 weeks

DRUG

Upadacitinib

15 mg orally once daily with subcutaneous placebo injection every 2 weeks

DRUG

Tocilizumab

162 mg administered SQ every 2 weeks

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Harry P Selker, MD · Tufts Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-15
Completion
2028-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06016517 on ClinicalTrials.gov