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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03555240
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10-27
• Status Verified: 2018-05
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-13
• Primary Completion: 2018-09-28
• Study Completion: 2018-09-28
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biobank creation	through study completion, an average of 5 years	Collection of biological samples from patients included into Emilia Romagna Rheumatoid Arthritis Registry

Secondary Outcome Measures

Name	Time	Method
Identification of genes potentially predictive of response to biological drugs	at 12 Months	Pharmacogenetics analysis of genes involved in the response to biological drugs

Trial Locations

Locations (10)

Rheumatology Unit IRCCS Orthopedic Rizzoli Institute; 🇮🇹 Bologna, BO, Italy

Rheumatology Unit, Internal Medicine Department of Internal Medicine and Nephrology diseases and Aging; 🇮🇹 Bologna, BO, Italy

Rheumatology Unit, Department of Internal Medicine Buflini Hospital; 🇮🇹 Cesena, FC, Italy

Medical Genetics Unit, Dept. of Biomedical and Specialty Surgery; 🇮🇹 Ferrara, FE, Italy

Rheumatology Unit S.Anna University Hospital; 🇮🇹 Ferrara, FE, Italy

Rheumatology Unit, Internal Medicine Department Morgagni Hospital; 🇮🇹 Forlì, Fo, Italy

Unit of Internal Medicine, Medical Internistic Department Ospedale Santa maria delle croci; 🇮🇹 Ravenna, RA, Italy

Division of Rheumatology Azienda Ospedaliera-IRCC S, Reggio Emilia; 🇮🇹 Reggio Emilia, RE, Italy

Department of Internal Medicine Infermis' Hospital; 🇮🇹 Rimini, RN, Italy

Laboratory of Immunorheumatology and Tissue Regeneration IRCC Rizzoli Orthopedic Institute; 🇮🇹 Bologna, Italy