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Italian Registry of Arthritis on Biologic Therapy (GISEA)

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ClinicalTrials.gov Identifier: NCT01543594
Recruitment Status : Recruiting
First Posted : March 5, 2012
Last Update Posted : March 20, 2018
Information provided by (Responsible Party):
Prof. Florenzo Iannone, Gruppo Italiano Studio Early Arthritis

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.

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis
Study Start Date : January 2009
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2025

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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by active polyarthritis beginning conventional biologic drugs

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543594

Contact: Giovanni Lapadula, MD +390805478867 g.lapadula@reumbari.uniba.it

GISEA Recruiting
Bari, Italy, 70124
Contact: Giovanni Lapadula, MD    +390805478866    g.lapadula@reumabari.uniba.it   
Principal Investigator: Giovanni Lapadula, MD         
Sponsors and Collaborators
Gruppo Italiano Studio Early Arthritis
Study Chair: Florenzo Iannone, MD University of Bari, Italy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Florenzo Iannone, Associate Professor of Rheumatology, University of Bari, Gruppo Italiano Studio Early Arthritis
ClinicalTrials.gov Identifier: NCT01543594     History of Changes
Other Study ID Numbers: DG-624
2012 ( Other Identifier: ANMAR )
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Prof. Florenzo Iannone, Gruppo Italiano Studio Early Arthritis:
Rheumatoid arthritis
Seronegative polyarthritis
Biologic drugs
Safety efficacy biologics polyarthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases