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

NCT03555240 | Completed

• 1 other identifier: PRUA1GR-2013-00000203
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 10

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Biobank creation

  Collection of biological samples from patients included into Emilia Romagna Rheumatoid Arthritis Registry

  through study completion, an average of 5 years

Secondary Outcomes (1)

• Identification of genes potentially predictive of response to biological drugs

  at 12 Months

Study Arms (1)

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

Interventions

Biobank creation and Pharmacogenetic analysis OTHER

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.

Patient with Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of Arthritis Rheumatoid according American College of Rheumatology (ACR)1987 or according ACR/European League Against Rheumatism (EULAR) 2010 criteria
• Patients with new diagnosis or patients already diagnosed with active disease \[with Disease Activity Score (DAS) 28 \> o = 4,2\] or patients switching therapy
• Male and female patients of minimum 18 years old
• Provision of informed consent

You may not qualify if:

• \) Patients living outside Emilia Romagna region

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Regione Emilia Romagna - Italy within PRU-Liberati project: collaborator

Study Sites (10)

Rheumatology Unit IRCCS Orthopedic Rizzoli Institute

Bologna, BO, 40136, Italy

Location

Rheumatology Unit, Internal Medicine Department of Internal Medicine and Nephrology diseases and Aging

Bologna, BO, 40138, Italy

Location

Rheumatology Unit, Department of Internal Medicine Buflini Hospital

Cesena, FC, 47521, Italy

Location

Medical Genetics Unit, Dept. of Biomedical and Specialty Surgery

Ferrara, FE, 44124, Italy

Location

Rheumatology Unit S.Anna University Hospital

Ferrara, FE, 44124, Italy

Location

Rheumatology Unit, Internal Medicine Department Morgagni Hospital

Forlì, Fo, 47121, Italy

Location

Unit of Internal Medicine, Medical Internistic Department Ospedale Santa maria delle croci

Ravenna, RA, 48100, Italy

Location

Division of Rheumatology Azienda Ospedaliera-IRCC S, Reggio Emilia

Reggio Emilia, RE, 42123, Italy

Location

Department of Internal Medicine Infermis' Hospital

Rimini, RN, 47921, Italy

Location

Laboratory of Immunorheumatology and Tissue Regeneration IRCC Rizzoli Orthopedic Institute

Bologna, 40136, Italy

Location

Related 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.

  PMID: 21359507 BACKGROUND

• 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.

  PMID: 2322158 BACKGROUND

• 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.

  PMID: 22166850 BACKGROUND

• 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.

  PMID: 23221586 BACKGROUND

• 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.

  PMID: 22044414 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Elisa Assirelli, BSc

  Rizzoli Orthopedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 13, 2018
• Study Start: October 27, 2014
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: November 12, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)