GISEA: Italian Registry of Arthritis on Biologic Therapy

Sponsor

Gruppo Italiano Studio Early Arthritis (Other)

Overall Status

Recruiting

CT.gov ID

NCT01543594

Collaborator

(none)

10,000

Enrollment

Location

203

Duration (Months)

49.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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