Italian Registry of Arthritis on Biologic Therapy

Overview

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.

Full Title of Study: “Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2022

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gruppo Italiano Studio Early Arthritis
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Florenzo Iannone, Associate Professor of Rheumatology, University of Bari – Gruppo Italiano Studio Early Arthritis
  • Overall Official(s)
    • Florenzo Iannone, MD, Study Chair, University of Bari, Italy
  • Overall Contact(s)
    • Giovanni Lapadula, MD, +390805478867, g.lapadula@reumbari.uniba.it

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