Registry of patients with rheumatoid arthritis on biologic therapy
Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis
This study is collecting information from people with rheumatoid arthritis who are starting biologic treatments to see how well these drugs work and how safe they are over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | Gruppo Italiano Studio Early Arthritis Research network |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Bari) |
| Trial ID | NCT01543594 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect clinical data from patients diagnosed with rheumatoid arthritis and related conditions who are starting treatment with biologic drugs. The focus is on assessing the long-term safety and efficacy of these therapies in real-world settings, particularly for patients whose disease has not responded to conventional treatments. By gathering comprehensive data, the study seeks to fill the gap in long-term outcomes associated with biologic therapies.
Who should consider this trial
Good fit: Ideal candidates include patients with rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis who have active disease and are refractory to traditional disease-modifying drugs.
Not a fit: Patients who do not meet the criteria for biologic therapy according to international guidelines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of biologic treatments for rheumatoid arthritis.
How similar studies have performed: Other studies have shown success in assessing the long-term effects of biologic therapies in similar patient populations, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bari
- Gisea — Bari, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Lapadula, MD
- Email: g.lapadula@reumbari.uniba.it
- Phone: +390805478867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.