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Italian Registry of Arthritis on Biologic Therapy (GISEA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Prof. Florenzo Iannone, Gruppo Italiano Studio Early Arthritis.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Prof. Florenzo Iannone, Gruppo Italiano Studio Early Arthritis Identifier:
First received: February 28, 2012
Last updated: March 2, 2012
Last verified: February 2012
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.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis

Resource links provided by NLM:

Further study details as provided by Prof. Florenzo Iannone, Gruppo Italiano Studio Early Arthritis:

Estimated Enrollment: 10000
Study Start Date: January 2009

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01543594

Contact: Giovanni Lapadula, MD +390805478867

GISEA Recruiting
Bari, Italy, 70124
Contact: Giovanni Lapadula, MD    +390805478866   
Principal Investigator: Giovanni Lapadula, MD         
Sponsors and Collaborators
Gruppo Italiano Studio Early Arthritis
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Florenzo Iannone, Associate Professor of Rheumatology, University of Bari, Gruppo Italiano Studio Early Arthritis Identifier: NCT01543594     History of Changes
Other Study ID Numbers: DG-624
2012 ( Other Identifier: ANMAR )
Study First Received: February 28, 2012
Last Updated: March 2, 2012

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 processed this record on May 25, 2017