Regional Registry-based Biobank Development and Pharmacogenetic Analysis in Rheumatoid Arthritis

Study Overview
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Brief Summary
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Aim of this project is the building-up of an integrated model of multidisciplinary research tools to support large-scale and high-quality disease-based studies.

Detailed Description
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Biologics have revolutionized rheumatoid arthritis (RA) management, with a great impact on patient that justifies treatment with these high-cost drugs. Nevertheless, timing and proper therapeutic decision making remain the main challenge in clinical practice. Pharmacogenetics approach might open promising perspectives, increasing our understanding on genetic-related drug efficacy. Nevertheless, to ensure feasibility and reliability of translational applications of this strategy in clinical practice, large population-based research studies represent a crucial key step. Objectives Major aim of this project is the building-up of an integrated model of multidisciplinary research tools to support large-scale and high-quality disease-based studies. The main targets of this proposal will be: to develop a disease-based biobank, integrated with already established Emilia-Romagna regional RA Registry, providing a large-scale prospective collection and storing of multiple biological samples to perform a pharmacogenetic study analyzing a panel of gene variants potentially influencing the response to Tumor Necrosis Factor (TNF) blockers. Methods Biobank development. A step-wise plan will be considered for: designing biobank governance frame-work, defining Standard Operating Procedures, implementing information system resources. All these procedures will be applied for collecting, processing and storing biological samples of patients included in regional RA registry. Pharmacogenetic study. A panel of candidate gene variants will be studied in genomic DNA from 300 patients enrolled in the regional RA registry. The association between genotypes and response to biological drugs will be assessed by data-mining approach, and a predictive model will be defined. Expected Results This proposal will create a disease-based biobank, tightly integrated with the already established Emilia-Romagna regional RA Registry, and pave the way towards personalized therapy applications in Rheumatology.

Official Title
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Regional Registry-based Biobank Development and Pharmacogenetic Analysis: Synergistic Strategies Driving Towards Personalized Medicine in Rheumatoid Arthritis Management

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Biobank creation and Pharmacogenetic analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Arthritis Rheumatoid according American College of Rheumatology (ACR)1987 or according ACR/European League Against Rheumatism (EULAR) 2010 criteria Patients with new diagnosis or patients already diagnosed with active disease [with Disease Activity Score (DAS) 28 > o = 4,2] or patients switching therapy Male and female patients of minimum 18 years old Provision of informed consent Exclusion Criteria: 1) Patients living outside Emilia Romagna region

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with Rheumatoid Arthritis<br>Patient with Rheumatoid Arthritis living in the Emilia Romagna Italian region whom samples will be collected for the Biobank creation and Pharmacogenetic analysis | Other: Biobank creation and Pharmacogenetic analysis<br>* Collection of biological samples (blood, serum, plasma) form patient enrolled in the Emilia Romagna rheumatoid arthritis registry and genotyping genomic DNA samples, and assessing the association between genotypes and response to biological drugs, using multivariate and data-mining approaches that includes also clinical and demographic parameters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biobank creation | Collection of biological samples from patients included into Emilia Romagna Rheumatoid Arthritis Registry | through study completion, an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genes potentially predictive of response to biological drugs | Pharmacogenetics analysis of genes involved in the response to biological drugs | at 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis