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

Recruiting now · Not applicable

Conditions studied: Rheumatoid Arthritis (RA)

In brief

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.

Key facts

Study ID: NCT07678112
Run by: Francisco J. Blanco
People needed: 184
Starts: 2025-08-28
Expected to finish: 2027-08-01
Last updated by the study team: 2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).
Ability and willingness to provide written informed consent to participate in the study.

You may not qualify if…

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.

Where it is running

Complejo Hospitalario Universitario de A Coruña — A Coruña, A Coruña, Spain (enrolling)
Hospital Universitario Araba — Alava, Alava, Spain (enrolling)
Hospital del Mar — Barcelona, Barcelona, Spain (enrolling)
Hospital Universitario La Princesa — Madrid, Madrid, Spain (enrolling)
Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain (enrolling)
Hospital Clínico San Carlos — Madrid, Madrid, Spain (enrolling)
Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain (enrolling)
Hospital Regional Universitario de Málaga — Málaga, Málaga, Spain (enrolling)
Hospital Universitario de Canarias — San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain (enrolling)

Full record on ClinicalTrials.gov

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