ArticleArthritis & rheumatology (Hoboken, N.J.)2017
Brief Report: Clinical Trials Aiming to Prevent Rheumatoid Arthritis Cannot Detect Prevention Without Adequate Risk Stratification: A Trial of Methotrexate Versus Placebo in Undifferentiated Arthritis as an Example.
Article in Arthritis & rheumatology (Hoboken, N.J.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis.Annals of the rheumatic diseases · 2021Guideline
- Prevention of rheumatoid arthritis: state-of-the-art and considerations for the design of new trials.EULAR rheumatology open · 2026Review
- Blood-based epigenetic biomarkers in rheumatoid arthritis: current knowledge and future perspectives.Frontiers in immunology · 2026Review
- A DNA methylation-based algorithm for diagnosing rheumatoid arthritis.Arthritis research & therapy · 2025Article
- Precision Medicine in Rheumatology: The Role of Biomarkers in Diagnosis and Treatment Optimization.Journal of clinical medicine · 2025Review
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- Preventive interventions in individuals at risk for Rheumatoid Arthritis: State of the art and perspectives.Joint bone spine · 2023Review
- A Roadmap for Investigating Preclinical Autoimmunity Using Patient-Oriented and Epidemiologic Study Designs: Example of Rheumatoid Arthritis.Frontiers in immunology · 2022Review
- Assessing improved risk prediction of rheumatoid arthritis by environmental, genetic, and metabolomic factors.Seminars in arthritis and rheumatism · 2021Article
- The Role of Imaging in Predicting the Development of Rheumatoid Arthritis.Rheumatology and immunology research · 2021Review
- Distinctive Clinical Characteristics and Outcome of ILD-Onset Rheumatoid Arthritis and ACPA-Positive ILD: a Longitudinal Cohort of 282 Cases.Clinical reviews in allergy & immunology · 2021Article
- [Management of early rheumatoid arthritis : Interdisciplinary guideline].Zeitschrift fur Rheumatologie · 2020Review
- Is the prevention of rheumatoid arthritis possible?Clinical rheumatology · 2020Review
- The earlier, the better or the worse? Towards accurate management of patients with arthralgia at risk for RA.Annals of the rheumatic diseases · 2020Article
- The Role of Ultrasound Across the Inflammatory Arthritis Continuum: Focus on "At-Risk" Individuals.Frontiers in medicine · 2020Review
- Impact of Cyclic Citrullinated Peptide Antibody Level on Progression to Rheumatoid Arthritis in Clinically Tested Cyclic Citrullinated Peptide Antibody-Positive Patients Without Rheumatoid Arthritis.Arthritis care & research · 2019Article
- A search to the target tissue in which RA-specific inflammation starts: a detailed MRI study to improve identification of RA-specific features in the phase of clinically suspect arthralgia.Arthritis research & therapy · 2019Article
- N-Linked Glycans in the Variable Domain of IgG Anti-Citrullinated Protein Antibodies Predict the Development of Rheumatoid Arthritis.Arthritis & rheumatology (Hoboken, N.J.) · 2019Article
- Oral and Subcutaneous Administration of a Near-Infrared Fluorescent Molecular Imaging Agent Detects Inflammation in a Mouse Model of Rheumatoid Arthritis.Scientific reports · 2019Article
- Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition.Nature reviews. Rheumatology · 2019Review
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivePrevention of rheumatoid arthritis (RA) was the aim of several trials in undifferentiated arthritis (UA), with overall negative results. As preparatory work has revealed that only ∼30% of UA patients progress to having RA, we hypothesized that inclusion of patients without imminent RA could lead to false-negative results. We undertook this study to evaluate this hypothesis by reinvestigating the Probable Rheumatoid Arthritis: Methotrexate versus Placebo Treatment (PROMPT) trial (a 1-year course of methotrexate [MTX] versus placebo in UA) after excluding patients without a high risk of developing RA.
methodsA validated prediction model was used to determine the risk of RA in all patients included in the PROMPT trial. Patients with a prediction score of ≥8 (positive predictive value of ≥84% for developing RA) were considered to have a high risk of developing RA. The effect of a 1-year course of MTX during 5 years of follow-up was reinvestigated in these patients.
resultsTwenty-two of the 110 patients in the PROMPT trial had a high risk of RA at baseline. In the MTX arm, 6 of 11 patients (55%) developed RA, compared to 11 of 11 patients (100%) in the placebo arm (P = 0.011). Time to RA development was longer in the MTX arm than in the placebo arm (median 22.5 months versus 3 months; P < 0.001). Drug-free remission was achieved by 4 of 11 patients (36%) in the MTX arm compared to 0 of 11 patients (0%) in the placebo arm (P = 0.031). These beneficial effects of MTX were observed both in anti-citrullinated protein antibody (ACPA)-positive and in ACPA-negative UA patients with a high risk of RA, but not in UA patients without a high risk of RA. In retrospect, 43 of 110 patients fulfilled the American College of Rheumatology/European League Against Rheumatism 2010 classification criteria for RA at baseline. In addition, beneficial effects were observed only in patients with a high prediction score.
conclusionA 1-year course of MTX delayed and prevented RA development in high-risk UA patients. This emphasizes the importance of adequate risk prediction in trials that aim to prevent RA.
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