Italian Registry of Arthritis on Biologic Therapy (GISEA)

  • STATUS
    Recruiting
  • End date
    Dec 26, 2025
  • participants needed
    10000
  • sponsor
    Gruppo Italiano Studio Early Arthritis
Updated on 1 March 2022
methotrexate
spondyloarthropathy
rheumatic diseases
tumor necrosis factor alpha
sulfasalazine
leflunomide
psoriatic arthritis
ankylosing spondylitis

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.

Details
Condition Rheumatoid Arthritis
Clinical Study IdentifierNCT01543594
SponsorGruppo Italiano Studio Early Arthritis
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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