Italian Registry of Arthritis on Biologic Therapy

Rheumatoid Arthritis Clinical Trial

— GISEA  

Official title:

Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01543594
• Other study ID #: DG-624
• Secondary ID: 2012
• Status: Recruiting
• Start date: January 2009
• Est. completion date: December 2025

Study information

• Verified date: September 2020
• Source: Gruppo Italiano Studio Early Arthritis
• Contact: Giovanni Lapadula, MD
• Phone: +390805478867
• Email: g.lapadula[@]reumbari.uniba.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2025
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Italy	GISEA	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Studio Early Arthritis

Country where clinical trial is conducted

Italy,