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Medical Device for Sustained Remission in Rheumatoid Arthritis Treated With Biological Therapy (REMRABIT-Plus)

2026년 6월 24일 업데이트: Francisco J. Blanco

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

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Background Rheumatoid arthritis (RA) is a chronic, immune-mediated inflammatory disease characterized by persistent synovitis, progressive joint damage, and reduced quality of life. The introduction of biological therapies, particularly tumor necrosis factor inhibitors (TNFi), has substantially improved disease outcomes, allowing many patients to achieve sustained remission.

In patients who reach remission, clinical guidelines recommend considering treatment optimization strategies, including dose tapering or discontinuation. However, in routine clinical practice, such decisions remain largely empirical and are primarily based on physician judgment. This approach introduces clinical uncertainty, as treatment reduction may lead to disease reactivation in a subset of patients, while continued treatment may expose patients to unnecessary risks and increase healthcare costs.

Rationale There is a clear unmet need for tools that support personalized treatment decisions in patients with RA in remission. A reliable method to predict the risk of disease flare could enable clinicians to better identify patients in whom treatment reduction can be safely implemented.

The OPTIBIO model has been developed as a predictive tool to address this need. It integrates clinical variables with biomarker data derived from peripheral blood, including protein expression, cellular components, and genetic information. By combining these data sources, the model aims to provide individualized risk predictions of disease reactivation following treatment optimization.

Study Purpose The purpose of this study is to evaluate the clinical utility of the OPTIBIO predictive model when incorporated into routine clinical decision-making, compared with standard practice.

The study assesses whether use of the model can support safer and more effective treatment optimization in patients with rheumatoid arthritis in remission receiving TNFi therapy.

Scientific and Clinical Contribution In addition to its clinical focus, the study includes the prospective collection of clinical data and biological samples to further investigate biomarkers associated with disease activity and relapse. These data will contribute to improving the predictive performance of the OPTIBIO model and to identifying novel molecular and cellular signatures associated with disease reactivation.

With participant consent, residual biological samples may be stored in authorized biobanks for future research. These samples may be used in ethically approved studies related to rheumatoid arthritis, contributing to a better understanding of disease mechanisms and to the development of new diagnostic and therapeutic approaches.

Health and Economic Relevance The study also addresses the broader impact of treatment optimization strategies on healthcare systems. By collecting data on healthcare resource utilization, it aims to explore the potential cost-effectiveness of incorporating predictive tools into routine care.

This is particularly relevant in chronic diseases such as RA, where long-term treatment costs and resource utilization are significant, and where more efficient, personalized treatment strategies could have substantial clinical and economic benefits.

Expected Impact This study is expected to generate evidence on the usefulness of a biomarker-based predictive approach to guide treatment decisions in rheumatoid arthritis. The implementation of such tools has the potential to improve patient outcomes, reduce the risk of disease flare, minimize unnecessary treatment exposure, and support more efficient use of healthcare resources.

연구 유형

중재적

등록 (추정된)

184

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Francisco J. Blanco, MD, PhD
  • 전화번호: +34981176399
  • 이메일: fblagar@sergas.es

연구 장소

  • 스페인
    • A Coruña
      • A Coruña, A Coruña, 스페인, 15006
        • 모병
        • Complejo Hospitalario Universitario de A Coruña
        • 연락하다:
    • Alava
      • Alava, Alava, 스페인, 01009
    • Barcelona
      • Barcelona, Barcelona, 스페인, 08003
        • 모병
        • Hospital Del Mar
        • 연락하다:
    • Madrid
      • Madrid, Madrid, 스페인, 28040
        • 모병
        • Hospital Clinico San Carlos
        • 연락하다:
      • Madrid, Madrid, 스페인, 28041
        • 모병
        • Hospital Universitario 12 de Octubre
        • 연락하다:
      • Madrid, Madrid, 스페인, 28007
      • Madrid, Madrid, 스페인, 28006
        • 모병
        • Hospital Universitario La Princesa
        • 연락하다:
    • Málaga
      • Málaga, Málaga, 스페인, 29010
        • 모병
        • Hospital Regional Universitario de Málaga
        • 연락하다:
    • Santa Cruz de Tenerife
      • San Cristóbal de La Laguna, Santa Cruz de Tenerife, 스페인, 38320
        • 모병
        • Hospital Universitario de Canarias
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Standard of care
Treatment optimization decisions are made by the treating physician according to routine clinical practice.
실험적: OPTIBIO-guided decision
Treatment optimization decisions are guided by the OPTIBIO predictive model, which integrates clinical and biomarker data to estimate the risk of disease flare.
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of patients maintaining sustained remission.
기간: 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
Up to 12 months
Incidence of adverse events
기간: 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.
Baseline to 70 days after last dose

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of patients achieving sustained acceptable therapeutic target
기간: Up to 12 months
Proportion of patients maintaining an acceptable therapeutic target throughout follow-up, defined as low disease activity (DAS28-CRP < 3.2) and absence of persistent inflammation in major joints (shoulders, elbows, hips, and knees).
Up to 12 months
Proportion of patients experiencing disease flare (0-6 months).
기간: Up to 6 months
Proportion of patients experiencing disease flare during the first 6 months of follow-up, defined as DAS28-CRP > 2.6.
Up to 6 months
Proportion of patients experiencing disease flare (6-12 months)
기간: 6 to 12 months
Proportion of patients experiencing disease flare between months 6 and 12 of follow-up, defined as DAS28-CRP > 2.6.
6 to 12 months
Number of disease flares (0-6 months)
기간: Up to 6 months
Total number of disease flares occurring during the first 6 months of follow-up.
Up to 6 months
Number of disease flares (6-12 months)
기간: 6 to 12 months
Total number of disease flares occurring between months 6 and 12 of follow-up.
6 to 12 months
Proportion of patients achieving acceptable therapeutic target at final visit
기간: At 12 months
Proportion of patients meeting the acceptable therapeutic target definition at the last study visit.
At 12 months
Proportion of patients in remission at final visit
기간: At 12 months
Proportion of patients in remission at the last study visit, defined as DAS28-CRP < 2.6.
At 12 months
Time to disease flare
기간: Up to 12 months
Time from baseline to the first occurrence of disease flare, defined as DAS28-CRP > 2.6.
Up to 12 months
Change in clinical disease activity parameters (joint count)
기간: Baseline to 12 months
Changes over time in clinical parameters: tender joint count (28 joints).
Baseline to 12 months
Change in clinical disease activity parameters (joint count)
기간: Baseline to 12 months
Changes over time in clinical parameters: swollen joint count (28 joints).
Baseline to 12 months
Change in clinical disease activity parameters: patient and physician global assessment
기간: Baseline to 12 months
Changes over time in clinical parameters: patient and physician global assessment (0-100 mm scale).
Baseline to 12 months
Change in clinical disease activity parameters: CRP
기간: Baseline to 12 months
Changes over time in clinical parameters: acute phase reactants, CRP (mg/L)
Baseline to 12 months
Change in health-related quality of life (EQ-5D-5L)
기간: Baseline to 12 months
Change in health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The score ranges from 0 to 1, where 1 represents perfect health
Baseline to 12 months
Change in functional disability (HAQ)
기간: Baseline to 12 months
Change in functional disability assessed using the Health Assessment Questionnaire (HAQ). The HAQ score can range from 0 (no disability) to 3 (maximum disability).
Baseline to 12 months
Direct and indirect healthcare costs and cost-effectiveness
기간: Up to 12 months
Assessment of direct and indirect healthcare costs and incremental cost-effectiveness and cost-utility ratios.
Up to 12 months
Use of concomitant medication
기간: Up to 12 months
Use of analgesics, non-steroidal anti-inflammatory drugs, and corticosteroids, including route of administration.
Up to 12 months
Radiographic structural damage progression
기간: Baseline and 12 months
Progression of structural damage assessed by blinded independent evaluators using the modified Sharp/van der Heijde scoring method on radiographs of hands, wrists, and feet.
Baseline and 12 months
Change in clinical disease activity parameters (ESR)
기간: Baseline to 12 months
Changes over time in clinical parameters: acute phase reactants, ESR (mm/h).
Baseline to 12 months

기타 결과 측정

결과 측정
측정값 설명
기간
Performance of predictive models based on molecular biomarkers
기간: Up to 12 months
Evaluation of sensitivity, specificity, and predictive values of models based on PRIME and RETRO biomarkers using clinical outcomes.
Up to 12 months
Performance of predictive models based on imaging biomarkers
기간: Up to 12 months
Evaluation of predictive performance of ultrasound-based biomarkers, including validation of deep learning models for inflammation assessment.
Up to 12 months
Biobank sample collection
기간: Baseline
Collection and storage of peripheral blood samples (serum, plasma, RNA, DNA) for future biomarker research.
Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Francisco J. Blanco

수사관

  • 수석 연구원: Francisco J. Blanco, MD, PhD, Complejo Hospitalario Universitario de A Coruña

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 8월 28일

기본 완료 (추정된)

2027년 8월 1일

연구 완료 (추정된)

2027년 8월 1일

연구 등록 날짜

최초 제출

2026년 6월 18일

QC 기준을 충족하는 최초 제출

2026년 6월 24일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 24일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • REMRABIT-Plus

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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