What the trial was testing
The MIRACLE enrolled 300 patients with rheumatoid arthritis. The study was sponsored by Keio University and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was long-term safety (phase 4). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
38% of patients on the lower dose achieved remission, matching the 44% on the higher dose.
The Lancet. Rheumatology · 2023 · NCT03505008
These findings — that lower and higher methotrexate doses worked equally well when combined with adalimumab — were published in the The Lancet. Rheumatology and represent the headline result of the study.
Researchers tracked outcomes across 300 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with rheumatoid arthritis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
If you take adalimumab and methotrexate together for rheumatoid arthritis, this study suggests a lower methotrexate dose might work just as well as a higher one — and may cause fewer side effects. Both drugs are FDA-approved for rheumatoid arthritis. Talk to your rheumatologist about whether a lower dose makes sense for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open rheumatoid arthritis trials
Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders
The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), anxiety disorders, depressive disorders and moderate depression. Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.
Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease
A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression. The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features.