Italian Registry of Arthritis on Biologic Therapy (GISEA)

Gruppo Italiano Studio Early Arthritis

Status: Enrolling

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01543594

DG-624

2012

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

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