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

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ClinicalTrials.gov Identifier: NCT03555240
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Regione Emilia Romagna - Italy within PRU-Liberati project
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Biobank creation and Pharmacogenetic analysis

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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regional Registry-based Biobank Development and Pharmacogenetic Analysis: Synergistic Strategies Driving Towards Personalized Medicine in Rheumatoid Arthritis Management
Actual Study Start Date : October 27, 2014
Estimated Primary Completion Date : September 28, 2018
Estimated Study Completion Date : September 28, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with residents in Emilia Romagna Region, partecipating to the regional rheumatoid arthritis registy
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555240


Contacts
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Contact: Elisa Assirelli, BSc 00390513666 ext 6093 elisa.assirelli@ior.it
Contact: Lia Pulsatelli, BSc 00390513666 ext 6092 lia.pulsatelli@ior.it

Locations
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Italy
Rheumatology Unit IRCCS Orthopedic Rizzoli Institute Recruiting
Bologna, BO, Italy, 40136
Contact: Riccardo Meliconi, MD         
Principal Investigator: Riccardo Meliconi, MD         
Rheumatology Unit, Internal Medicine Department of Internal Medicine and Nephrology diseases and Aging Recruiting
Bologna, BO, Italy, 40138
Contact: Nazzarena Malavolta, MD         
Principal Investigator: Nazzarena Malavolta, MD         
Rheumatology Unit, Department of Internal Medicine Buflini Hospital Recruiting
Cesena, FC, Italy, 47521
Contact: Luca Montaguti, MD         
Principal Investigator: Luca Montaguti, MD         
Medical Genetics Unit, Dept. of Biomedical and Specialty Surgery Recruiting
Ferrara, FE, Italy, 44124
Contact: Michele Rubini, PhD         
Rheumatology Unit S.Anna University Hospital Recruiting
Ferrara, FE, Italy, 44124
Contact: Marcello Govoni, MD         
Rheumatology Unit, Internal Medicine Department Morgagni Hospital Recruiting
Forlì, Fo, Italy, 47121
Contact: Francesco Girelli, Girelli         
Principal Investigator: Francesco Girelli, Girelli         
Unit of Internal Medicine, Medical Internistic Department Ospedale Santa maria delle croci Recruiting
Ravenna, RA, Italy, 48100
Contact: Simona Bosi, MD         
Principal Investigator: Simona Bosi, MD         
Division of Rheumatology Azienda Ospedaliera-IRCC S, Reggio Emilia Recruiting
Reggio Emilia, RE, Italy, 42123
Contact: Carlo Salvarani, MD         
Principal Investigator: Carlo Salvarani, MD         
Department of Internal Medicine Infermis' Hospital Recruiting
Rimini, RN, Italy, 47921
Contact: Alessandra Bezzi, MD         
Principal Investigator: Alessandra Bezzi, MD         
Laboratory of Immunorheumatology and Tissue Regeneration IRCC Rizzoli Orthopedic Institute Recruiting
Bologna, Italy, 40136
Contact: Elisa Assirelli, BSc    +390516366 ext 6093    elisa.assirelli@ior.it   
Principal Investigator: Elisa Assirelli, BSc         
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Regione Emilia Romagna - Italy within PRU-Liberati project
Investigators
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Principal Investigator: Elisa Assirelli, BSc Rizzoli Orthopedic Institute
  Study Documents (Full-Text)

Documents provided by Istituto Ortopedico Rizzoli:
Study Protocol  [PDF] May 20, 2014


Publications:
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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03555240     History of Changes
Other Study ID Numbers: PRUA1GR-2013-00000203
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Ortopedico Rizzoli:
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases