Not yet recruitingPhase not listed

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares approved medicines for rheumatoid arthritis (RA), a disease that causes swollen, painful joints. It is for adults with newly diagnosed RA who still have symptoms after methotrexate or cannot tolerate it. The study aims to find which treatments work best for each person and for the group.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with newly diagnosed RA that began in adulthood.
  • Have active RA with at least 6 tender joints and 6 swollen joints.
  • Have a CRP blood test, which measures inflammation, at or above the upper end of normal.
  • Still have active RA after at least 12 weeks of methotrexate (MTX), with the same dose for at least 8 weeks, or have stopped MTX because of harmful or intolerable effects.
  • Have never taken etanercept, adalimumab, upadacitinib, or tocilizumab.
  • Give informed consent, with a qualified interpreter if needed.
  • Be able to take pills and willing to follow all study steps and treatment periods for the full study.
  • Have an insurance plan that takes part in this trial. A trained study doctor will decide if you qualify.

Who can't join

  • Arthritis that began before age 17, or another current joint disease that causes inflammation.
  • Allergy to ingredients in the study medicines; steroid shots into a joint, vein, or muscle within 28 days; more than 10 mg of prednisone daily or an equal dose of another steroid; or recent steroid dose changes.
  • Heart attack, unstable heart disease, or stroke within 12 weeks; the most severe level of heart failure; or a past blood clot in a deep vein or the lungs.
  • Tuberculosis, hepatitis B or C, a history of HIV, a current or recent serious infection, shingles symptoms within 12 weeks, or a weakened immune system that makes treatment unsafe.
  • Poor kidney function; chronic liver disease with certain abnormal blood tests; certain cancers or diseases that cause too many white blood cells; or another serious illness that could make the study unsafe or affect results.
  • A live vaccine within 12 weeks before treatment assignment, or a need for one during the study, except for a shingles vaccine.
  • Pregnant, breastfeeding, or able to become pregnant but unwilling to use effective birth control.
  • In the hospital or needing hospital care at screening, taking part in another RA treatment trial, or lacking internet access for online study visits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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 * Had to discontinue MTX due to intolerability or toxicity, irrespective of treatment duration * Have never received etanercept, adalimumab, upadacitinib, or tocilizumab prior to first dose of study drug. * Provision of informed consent in English or another language in which a validated consent form is available, or via short-form consent with the assistance of a qualified interpreter. * Stated willingness to comply with all study procedures and availability for the duration of the study * 18 years of age or older * Ability to take oral medication and be willing to adhere to all treatment periods * Patients are eligible whether their disease responded partially or inadequately to first-line MTX or if they were intolerant to first-line MTX * Enrollment in an insurance plan that participates in or is subscribed to this trial An individual who meets any of the following criteria will be excluded from participation in this study: * History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA * Has received intra-articular, intravenous, intramuscular corticosteroids within 28 days prior to baseline * Known allergic reactions to components of any of the investigative biologic agents * Is currently receiving corticosteroids at doses \> (greater than) 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization * Has experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure * Tuberculosis infection * Hepatitis B or C infection * History of venous thromboembolic event (deep vein thrombosis, pulmonary embolism) * Has a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk or could interfere with the interpretation of data * Has an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine of \< (less than) 40 milliliter per minute per 1.73 m\^2 (mL/min/1.73 m\^2) * Has a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN * Has a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for \<5 years * Has been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination) * Has a current or recent clinically serious viral, bacterial, fungal, or parasitic infection * Has had symptomatic herpes zoster infection within 12 weeks prior to study entry * Has immunocompromising condition and, in the opinion of the investigator, are at an unacceptable risk for participating in the study and using these medications * Has a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\* * Has evidence of active or latent tuberculosis (TB) * Current hospitalization or requiring hospital admission at screening * Pregnant or breastfeeding * Of childbearing potential, unwilling to use effective birth control method (highly effective contraceptive measure (e.g., combined (estrogen and progestogen containing) hormonal contraception; intrauterine device) * Participation in another therapeutic clinical trial for RA * Lack of internet access to telehealth platform State who will determine eligibility. Note that those who are designated to determine eligibility must have appropriate training, expertise, and oversight, for example a physician PI or Co-I on a biomedical study: Eligibility will be determined by the appropriately trained and delegated physician investigator or physician Co- investigator.

Study sites (1)

MA