Regional Registry-based Biobank Development and Pharmacogenetic Analysis in Rheumatoid Arthritis
NCT ID: NCT03555240
Last Updated: 2019-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2014-10-27
2018-09-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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Regione Emilia Romagna - Italy within PRU-Liberati project
UNKNOWN
Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Principal Investigators
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Elisa Assirelli, BSc
Role: PRINCIPAL_INVESTIGATOR
Rizzoli Orthopedic Institute
Locations
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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
Countries
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References
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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.
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. doi: 10.1001/archopht.1990.01070060099057.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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PRUA1GR-2013-00000203
Identifier Type: -
Identifier Source: org_study_id
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