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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Percentage of patients maintaining sustained remission. — Up to 12 months
  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 — Baseline to 70 days after last dose
  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.

Trial sites (9)

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