Working… Menu

Italian Registry of Arthritis on Biologic Therapy (GISEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01543594
Recruitment Status : Recruiting
First Posted : March 5, 2012
Last Update Posted : September 29, 2020
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

Layout table for study information
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 2022
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01543594

Layout table for location contacts
Contact: Giovanni Lapadula, MD +390805478867

Layout table for location information
GISEA Recruiting
Bari, Italy, 70124
Contact: Giovanni Lapadula, MD    +390805478866   
Principal Investigator: Giovanni Lapadula, MD         
Sponsors and Collaborators
Gruppo Italiano Studio Early Arthritis
Layout table for investigator information
Study Chair: Florenzo Iannone, MD University of Bari, Italy
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Prof. Florenzo Iannone, Associate Professor of Rheumatology, University of Bari, Gruppo Italiano Studio Early Arthritis Identifier: NCT01543594    
Other Study ID Numbers: DG-624
2012 ( Other Identifier: ANMAR )
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
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:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases