Italian Registry of Arthritis on Biologic Therapy

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01543594

Acronym

GISEA

Enrollment

10000

Registered

2012-03-05

Start date

2009-01-31

Completion date

2025-12-31

Last updated

2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Seronegative polyarthritis, Biologic drugs, Safety efficacy biologics polyarthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 80 Years

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

Countries

Italy

Contacts

Primary ContactGiovanni Lapadula, MD

g.lapadula@reumbari.uniba.it+390805478867

Outcome results