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

2026年6月24日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

184

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Francisco J. Blanco, MD, PhD
  • 電話番号：+34981176399
  • メール：fblagar@sergas.es

研究場所

  • スペイン
    • A Coruña
      • A Coruña、A Coruña、スペイン、15006
        • 募集
        • Complejo Hospitalario Universitario de A Coruña
        • コンタクト：
    • Alava
      • Alava、Alava、スペイン、01009
    • Barcelona
      • Barcelona、Barcelona、スペイン、08003
        • 募集
        • Hospital Del Mar
        • コンタクト：
    • Madrid
      • Madrid、Madrid、スペイン、28040
        • 募集
        • Hospital Clinico San Carlos
        • コンタクト：
      • Madrid、Madrid、スペイン、28041
        • 募集
        • Hospital Universitario 12 de Octubre
        • コンタクト：
      • Madrid、Madrid、スペイン、28007
        • 募集
        • Hospital General Universitario Gregorio Marañón
        • コンタクト：
      • Madrid、Madrid、スペイン、28006
        • 募集
        • Hospital Universitario La Princesa
        • コンタクト：
    • Málaga
      • Málaga、Málaga、スペイン、29010
        • 募集
        • Hospital Regional Universitario de Málaga
        • コンタクト：
    • Santa Cruz de Tenerife
      • San Cristóbal de La Laguna、Santa Cruz de Tenerife、スペイン、38320
        • 募集
        • Hospital Universitario de Canarias
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：ヘルスサービス研究
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
介入なし：Standard of care
Treatment optimization decisions are made by the treating physician according to routine clinical practice.
実験的：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.
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of patients maintaining sustained remission.
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of patients achieving sustained acceptable therapeutic target
時間枠：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).
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Baseline to 12 months
Changes over time in clinical parameters: acute phase reactants, ESR (mm/h).
Baseline to 12 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Performance of predictive models based on molecular biomarkers
時間枠：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
時間枠：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
時間枠：Baseline
Collection and storage of peripheral blood samples (serum, plasma, RNA, DNA) for future biomarker research.
Baseline

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Francisco J. Blanco

捜査官

  • 主任研究者：Francisco J. Blanco, MD, PhD、Complejo Hospitalario Universitario de A Coruña

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年8月28日

一次修了 (推定)

2027年8月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年6月18日

QC基準を満たした最初の提出物

2026年6月24日

最初の投稿 (実際)

2026年7月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月1日

QC基準を満たした最後の更新が送信されました

2026年6月24日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • REMRABIT-Plus

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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