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

Rheumatoid Arthritis Clinical Trial

— RABiobank  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555240
• Other study ID #: PRUA1GR-2013-00000203
• Status: Completed
• Start date: October 27, 2014
• Est. completion date: September 28, 2018

Study information

• Verified date: May 2018
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
Italy	Laboratory of Immunorheumatology and Tissue Regeneration IRCC Rizzoli Orthopedic Institute	Bologna
Italy	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

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli	Regione Emilia Romagna - Italy within PRU-Liberati project

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biobank creation	Collection of biological samples from patients included into Emilia Romagna Rheumatoid Arthritis Registry	through study completion, an average of 5 years
Secondary	Identification of genes potentially predictive of response to biological drugs	Pharmacogenetics analysis of genes involved in the response to biological drugs	at 12 Months