NCT04671706Not yet recruiting
Belimumab in Patients With Systemic Lupus Erythematosus
Effectiveness, Tolerability, and Safety of Belimumab in Patients With Systemic Lupus Erythematosus Treated at the Spanish Departments of Internal Medicine
Source: ClinicalTrials.gov · Last updated 17 Dec 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The BeliLES-GEAS project pretends to obtain an extensive data registry of patients with systemic lupus erythematosus (SLE). The main objective is to create a national SLE patients registry treated with belimumab to describe effectiveness and safety of intravenous (IV) or subcutaneous (SC) belimumab in patients with active SLE treated in the Spanish departments of Internal Medicine in a real-life setting. This research project aspires to cover the vast majority (if not the whole) of SLE patients treated with belimumab in all of the Spanish Departments of Internal Medicine.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 11 Dec 2020
- Start date
- Jan 2021
- Primary completion date
- Dec 2025
- Lead sponsor
- Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Fundación Española de Medicina
- Diseases
- Lupus (SLE)
- NCT number
- NCT04671706
What you commit to
- Study type: Observational
- Planned participants: 3000
- From Jan 2021 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 1\) Negative from the patient to participate in the study.
Who the study is looking for
- Fulfillment of the 2019 EULAR/ACR classification criteria for SLE, SLICC classification criteria, 1997 American College of Rheumatology (ACR) revised criteria for SLE or patients with only 3 criteria but SLE diagnosed according to the clinical judgment of the treating physician.
- Age of 18 years or more.
- Having received at least one dose of intravenous or subcutaneous belimumab according the physician criteria regardless the clinical/immunological response.
- Signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.