RecruitingNot ApplicableNCT07678112

Medical Device for Sustained Remission in Rheumatoid Arthritis Treated With Biological Therapy

Efficacy, Safety and Cost-effectiveness of a Biomarker-based Predictive Model for Persistent Remission in Rheumatoid Arthritis Patients Undergoing Biological Therapy Optimization


Sponsor

Francisco J. Blanco

Enrollment

184 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Predictive Model-Guided Decision Strategy for people with rheumatoid arthritis (ra). The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPredictive Model-Guided Decision Strategy

Treatment 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.


Locations(9)

Complejo Hospitalario Universitario de A Coruña

A Coruña, A Coruña, Spain

Hospital Universitario Araba

Alava, Alava, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Universitario La Princesa

Madrid, Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain

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NCT07678112


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