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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 28, 2018

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.

Interventions

  • Other: Biobank creation and Pharmacogenetic analysis
    • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Identification of genes potentially predictive of response to biological drugs
    • Time Frame: at 12 Months
    • Pharmacogenetics analysis of genes involved in the response to biological drugs

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istituto Ortopedico Rizzoli
  • Collaborator
    • Regione Emilia Romagna – Italy within PRU-Liberati project
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elisa Assirelli, BSc, Principal Investigator, Rizzoli Orthopedic Institute

References

Boonen A, Severens JL. The burden of illness of rheumatoid arthritis. Clin Rheumatol. 2011 Mar;30 Suppl 1:S3-8. doi: 10.1007/s10067-010-1634-9. Epub 2011 Feb 26. Review.

Hamilton SR, Chatrian GE, Mills RP, Kalina RE, Bird TD. Cone dysfunction in a subgroup of patients with autosomal dominant cerebellar ataxia. Arch Ophthalmol. 1990 Apr;108(4):551-6.

Scott DL. Biologics-based therapy for the treatment of rheumatoid arthritis. Clin Pharmacol Ther. 2012 Jan;91(1):30-43. doi: 10.1038/clpt.2011.278. Epub 2011 Dec 14. Review.

Ruderman EM. Overview of safety of non-biologic and biologic DMARDs. Rheumatology (Oxford). 2012 Dec;51 Suppl 6:vi37-43. doi: 10.1093/rheumatology/kes283. Review.

Prajapati R, Plant D, Barton A. Genetic and genomic predictors of anti-TNF response. Pharmacogenomics. 2011 Nov;12(11):1571-85. doi: 10.2217/pgs.11.114. Review.

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