This study aims to evaluate a new tool designed to help doctors decide whether it is safe to reduce medication in patients with rheumatoid arthritis (RA) who are in remission.
Rheumatoid arthritis is a chronic inflammatory disease that affects the joints, causing pain, stiffness, and reduced mobility. Many patients receive long-term treatment with biological drugs to control the disease. When the disease is well controlled (remission), doctors may gradually reduce the medication dose. However, deciding when and in whom to reduce treatment is currently based on experience and trial-and-error.
The study evaluates a predictive tool (called OPTIBIO) that uses information from blood samples, genetic data, and clinical characteristics to estimate the risk that the disease will flare up if treatment is reduced.
Participants in the study will be randomly assigned to one of two groups:
* In one group, the decision to reduce medication will be made by their usual doctor. * In the other group, the decision will be guided by the predictive tool.
The study lasts 12 months and includes several hospital visits. During these visits, participants will:
* Answer questionnaires about their health and quality of life * Have physical examinations * Provide blood samples for routine tests and additional research purposes * Possibly undergo joint ultrasound (if they consent) Some additional blood samples may be stored in authorized biobanks for future research related to rheumatoid arthritis, but only if participants explicitly agree. These samples will be coded to protect personal identity and will only be used in ethically approved research projects.
Participation in the study is entirely voluntary. Participants can choose which procedures they agree to and may withdraw at any time without affecting their medical care.
The study may not provide direct benefit to participants, but it could help improve future treatment decisions and the overall management of rheumatoid arthritis.
Adults aged ≥18 years.
Diagnosis of rheumatoid arthritis according to either the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/EULAR classification criteria.
Clinical remission for at least 6 months prior to the baseline visit, defined as DAS28-CRP < 2.6.
Receiving biological anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab, or certolizumab).
Patients in whom biological therapy was prescribed due to systemic manifestations of rheumatoid arthritis.
Patients with rheumatoid arthritis and any known associated condition that may interfere with the assessment of study outcomes (e.g., fibromyalgia or concomitant chronic inflammatory diseases).
Patients receiving chronic anti-TNF biological therapy who are already undergoing treatment tapering or are on reduced or extended dosing regimens prior to study inclusion.
Parallel
Predictive Model-Guided Decision Strategy
DeviceTreatment optimization decisions are guided by the OPTIBIO predictive model, which integrates clinical variables with biomarker data derived from peripheral blood, including protein expression and genetic information. The model provides an individualized estimation of the risk of disease flare associated with treatment reduction and generates a recommendation on whether to maintain or taper biological therapy.
Percentage of patients maintaining sustained remission.
Proportion of patients who remain in sustained remission throughout the entire follow-up period, defined as DAS28-CRP \< 2.6 based on tender joint count (28 joints), swollen joint count (28 joints), C-reactive protein levels, and patient global assessment
Incidence of adverse events
Incidence and characteristics of adverse events, including serious infections requiring systemic antibiotics or hospitalization, serious treatment-related adverse events, and specific adverse reactions (e.g., infusion or injection reactions), including severity.
Proportion of patients achieving sustained acceptable therapeutic target
Proportion of patients maintaining an acceptable therapeutic target throughout follow-up, defined as low disease activity (DAS28-CRP \< 3.2) and absence of persistent inflammation in major joints (shoulders, elbows, hips, and knees).
Proportion of patients experiencing disease flare (0-6 months).
Proportion of patients experiencing disease flare during the first 6 months of follow-up, defined as DAS28-CRP \> 2.6.
Proportion of patients experiencing disease flare (6-12 months)
Proportion of patients experiencing disease flare between months 6 and 12 of follow-up, defined as DAS28-CRP \> 2.6.
Number of disease flares (0-6 months)
Total number of disease flares occurring during the first 6 months of follow-up.
Performance of predictive models based on molecular biomarkers
Evaluation of sensitivity, specificity, and predictive values of models based on PRIME and RETRO biomarkers using clinical outcomes.
Performance of predictive models based on imaging biomarkers
Evaluation of predictive performance of ultrasound-based biomarkers, including validation of deep learning models for inflammation assessment.
Biobank sample collection
Collection and storage of peripheral blood samples (serum, plasma, RNA, DNA) for future biomarker research.
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Francisco J. Blanco
Lead sponsor
Hospital San Carlos, Madrid
Sponsor institution
