Italian Registry of Arthritis on Biologic Therapy (GISEA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Gruppo Italiano Studio Early Arthritis.
Recruitment status was  Recruiting
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
  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:


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
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, see Learn About Clinical Studies.

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 by Gruppo Italiano Studio Early Arthritis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014