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Clinical Trials in Spain / NCT04671706
Starting soon Observational

Belimumab in Patients With Systemic Lupus Erythematosus

NCT04671706 · tracked via the Priya Life Science Spain tracker
Sponsor
Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Fundación Española de Medicina
Phase
Observational
Started
2021-01
Last updated
2020-12-17

Condition(s) studied

Systemic Lupus Erythematosus

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Age of 18 years or more. 3. Having received at least one dose of intravenous or subcutaneous belimumab according the physician criteria regardless the clinical/immunological response. 4. Signed informed consent. Exclusion Criteria: 1\) Negative from the patient to participate in the study.

Primary outcome measure(s)

  • Disease activity, clinical outcomes, and describe overall patterns of SLE care — 2 years
    Study endpoints are clinically recognized (and objectively confirmed). Additional endpoints will be the identification of predictors of response in our patients

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinic Barcelona Barcelona Spain

Other trials for the same condition

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus Active, not recruiting
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE) Active, not recruiting
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) Active, not recruiting
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus Recruiting
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04671706 on ClinicalTrials.gov ↗ ← All trials in Spain