Regional Registry-based Biobank Development and Pharmacogenetic Analysis in Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Other: Biobank creation and Pharmacogenetic analysis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- 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
- Patients living outside Emilia Romagna region
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient with Rheumatoid Arthritis Biobank creation and Pharmacogenetic analysis Patient with Rheumatoid Arthritis living in the Emilia Romagna Italian region whom samples will be collected for the Biobank creation and Pharmacogenetic analysis
- 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
Medical Genetics Unit, Dept. of Biomedical and Specialty Surgery
🇮🇹Ferrara, FE, 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
Rheumatology Unit, Internal Medicine Department Morgagni Hospital
🇮🇹Forlì, Fo, Italy
Division of Rheumatology Azienda Ospedaliera-IRCC S, Reggio Emilia
🇮🇹Reggio Emilia, RE, Italy
Rheumatology Unit S.Anna University Hospital
🇮🇹Ferrara, FE, Italy
Unit of Internal Medicine, Medical Internistic Department Ospedale Santa maria delle croci
🇮🇹Ravenna, RA, Italy
Department of Internal Medicine Infermis' Hospital
🇮🇹Rimini, RN, Italy
Laboratory of Immunorheumatology and Tissue Regeneration IRCC Rizzoli Orthopedic Institute
🇮🇹Bologna, Italy