Text Size

Italian Registry of Arthritis on Biologic Therapy (GISEA)

This study is currently recruiting participants.
Verified February 2012 by Gruppo Italiano Studio Early Arthritis
Sponsor:
Information provided by (Responsible Party):
Prof. Florenzo Iannone, Gruppo Italiano Studio Early Arthritis
ClinicalTrials.gov Identifier:
NCT01543594
First received: February 28, 2012
Last updated: March 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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
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:

U.S. FDA Resources

Further study details as provided by Gruppo Italiano Studio Early Arthritis:

Estimated Enrollment: 10000
Study Start Date: January 2009
  Eligibility

Ages Eligible for Study:   14 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients affected by active polyarthritis beginning conventional biologic drugs

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543594

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

Locations
Italy
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
  More Information

No publications provided

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
Study First Received: February 28, 2012
Last Updated: March 2, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Gruppo Italiano Studio Early Arthritis:
Rheumatoid arthritis
Seronegative polyarthritis
Biologic drugs
Safety efficacy biologics polyarthritis

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

ClinicalTrials.gov processed this record on May 16, 2013