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

November 8, 2019 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Laboratory of Immunorheumatology and Tissue Regeneration IRCC Rizzoli Orthopedic Institute
    • BO
      • Bologna, BO, Italy, 40136
        • Rheumatology Unit IRCCS Orthopedic Rizzoli Institute
      • Bologna, BO, Italy, 40138
        • Rheumatology Unit, Internal Medicine Department of Internal Medicine and Nephrology diseases and Aging
    • FC
      • Cesena, FC, Italy, 47521
        • Rheumatology Unit, Department of Internal Medicine Buflini Hospital
    • FE
      • Ferrara, FE, Italy, 44124
        • Medical Genetics Unit, Dept. of Biomedical and Specialty Surgery
      • Ferrara, FE, Italy, 44124
        • Rheumatology Unit S.Anna University Hospital
    • Fo
      • Forlì, Fo, Italy, 47121
        • Rheumatology Unit, Internal Medicine Department Morgagni Hospital
    • RA
      • Ravenna, RA, Italy, 48100
        • Unit of Internal Medicine, Medical Internistic Department Ospedale Santa maria delle croci
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Division of Rheumatology Azienda Ospedaliera-IRCC S, Reggio Emilia
    • RN
      • Rimini, RN, Italy, 47921
        • Department of Internal Medicine Infermis' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with residents in Emilia Romagna Region, partecipating to the regional rheumatoid arthritis registy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: at 12 Months
Pharmacogenetics analysis of genes involved in the response to biological drugs
at 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Collaborators

Regione Emilia Romagna - Italy within PRU-Liberati project

Investigators

  • Principal Investigator: Elisa Assirelli, BSc, Rizzoli Orthopedic Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 27, 2014

Primary Completion (ACTUAL)

September 28, 2018

Study Completion (ACTUAL)

September 28, 2018

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (ACTUAL)

June 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRUA1GR-2013-00000203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No Plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Biobank creation and Pharmacogenetic analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe