Italian Registry of Arthritis on Biologic Therapy

NCT ID: NCT01543594

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2025-12-31

Brief Summary

The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis
• Patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine)
• Patients eligible to begin conventional biologic therapy

Exclusion Criteria

• Any criteria excluding treatment with biologic drugs according to international guidelines

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Studio Early Arthritis

NETWORK

Sponsor Role: lead

Responsible Party

Prof. Florenzo Iannone

Associate Professor of Rheumatology, University of Bari

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Florenzo Iannone, MD

Role: STUDY_CHAIR

University of Bari

Locations

GISEA

Bari, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Lapadula, MD

Role: CONTACT

g.lapadula@reumbari.uniba.it

+390805478867

Facility Contacts

Giovanni Lapadula, MD

Role: primary

g.lapadula@reumabari.uniba.it

+390805478866

References

Cacciapaglia F, Manfredi A, Erre G, Piga M, Sakellariou G, Viapiana O, Gremese E, Spinelli FR, Atzeni F, Bartoloni E. Correspondence on 'Characteristics associated with hospitalisation for COVID-19 in people with rheumatic disease: data from the COVID-19 global rheumatology alliance physician-reported registry' by Gianfrancesco M et al. The impact of cardiovascular comorbidity on COVID-19 infection in a large cohort of rheumatoid arthritis patients. Ann Rheum Dis. 2023 Jul;82(7):e159. doi: 10.1136/annrheumdis-2020-218813. Epub 2020 Sep 15. No abstract available.

Reference Type: DERIVED

PMID: 32933920 (View on PubMed)

Iannone F, La Montagna G, Bagnato G, Gremese E, Giardina A, Lapadula G. Safety of etanercept and methotrexate in patients with rheumatoid arthritis and hepatitis C virus infection: a multicenter randomized clinical trial. J Rheumatol. 2014 Feb;41(2):286-92. doi: 10.3899/jrheum.130658. Epub 2014 Jan 15.

Reference Type: DERIVED

PMID: 24429167 (View on PubMed)

Other Identifiers

2012

Identifier Type: OTHER

Identifier Source: secondary_id

DG-624

Identifier Type: -

Identifier Source: org_study_id