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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03555240
Other study ID # PRUA1GR-2013-00000203
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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