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

NCT07678112 | Recruiting

• 1 other identifier: REMRABIT-Plus
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 9

Brief 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)

Keywords

Rheumatoid arthritis; Treatment Optimization; TNF Inhibitors (TNFi); Biologic Therapy; Personalized Medicine; Precision Medicine

Outcome Measures

Primary Outcomes (2)

• 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

  Up to 12 months

• 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.

  Baseline to 70 days after last dose

Secondary Outcomes (18)

• Proportion of patients achieving sustained acceptable therapeutic target

  Up to 12 months

• Proportion of patients experiencing disease flare (0-6 months).

  Up to 6 months

• Proportion of patients experiencing disease flare (6-12 months)

  6 to 12 months

• Number of disease flares (0-6 months)

  Up to 6 months

• Number of disease flares (6-12 months)

  6 to 12 months

Other Outcomes (3)

• Performance of predictive models based on molecular biomarkers

  Up to 12 months

• Performance of predictive models based on imaging biomarkers

  Up to 12 months

• Biobank sample collection

  Baseline

Study Arms (2)

Standard of care

NO INTERVENTION

Treatment optimization decisions are made by the treating physician according to routine clinical practice.

OPTIBIO-guided decision

EXPERIMENTAL

Treatment optimization decisions are guided by the OPTIBIO predictive model, which integrates clinical and biomarker data to estimate the risk of disease flare.

Device: Predictive Model-Guided Decision Strategy

Interventions

Predictive Model-Guided Decision Strategy DEVICE

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.

OPTIBIO-guided decision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Francisco J. Blanco: lead

Study Sites (9)

Complejo Hospitalario Universitario de A Coruña

A Coruña, A Coruña, 15006, Spain

RECRUITING

Hospital Universitario Araba

Alava, Alava, 01009, Spain

RECRUITING

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

RECRUITING

Hospital Universitario La Princesa

Madrid, Madrid, 28006, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, Málaga, 29010, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Francisco J. Blanco, MD, PhD

  Complejo Hospitalario Universitario de A Coruña

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco J. Blanco, MD, PhD

CONTACT

+34981176399; fblagar@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Three levels of blinding are implemented: * Participants and blinded consulting investigators are aware of whether treatment has been optimized, but are not informed about the decision-making process that led to treatment optimization. * Blinded outcome assessors are not aware of either the treatment optimization status or the decision-making process. * Non-blinded investigators have full knowledge of both treatment optimization and the decision-making process.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 1, 2026
• Study Start: August 28, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

ES (9)