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

NCT07678112 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-07-01

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DEVICE

Predictive 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.

Sponsors & Collaborators

  • Francisco J. Blanco

    lead OTHER

Principal Investigators

  • Francisco J. Blanco, MD, PhD · Complejo Hospitalario Universitario de A Coruña

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678112 on ClinicalTrials.gov