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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: Biobank creation and Pharmacogenetic analysis

Study type: Observational

Funder types: Other

Identifiers

NCT03555240

PRUA1GR-2013-00000203

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Patients living outside Emilia Romagna region

Trial design

600 participants in 1 patient group

Patient with Rheumatoid Arthritis

Description:

Patient with Rheumatoid Arthritis living in the Emilia Romagna Italian region whom samples will be collected for the Biobank creation and Pharmacogenetic analysis

Treatment:

Other: Biobank creation and Pharmacogenetic analysis