Belimumab in Patients With Systemic Lupus Erythematosus

NCT ID: NCT04671706

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

The goal of BeliLES-GEAS registry is to create an observational, non-randomized, non-controlled, national multicenter prospective and retrospective cohort with the aim to explore the real performance, with its lights and shadows, of Belimumab, either IV or SC, in a real-world population of lupus patients.

The intention is to perform a longer-term follow up, so that the measure of hard outcomes, such as improvement in mortality, could be feasible, but also reliable data regarding the safety profile could be recorded.

In order to achieve that, the following variables will be included: individual criteria as part of 2019 EULAR/ACR, SLICC or ACR 1997 classification criteria, gender, age at diagnosis, age at symptoms onset, duration of the disease, age at first Belimumab administration, mean time of follow-up prior to, and from Belimumab administration, complete medical history including other systemic autoimmune diseases, type/s of organ/systems affected by SLE, prior immunosuppressants received, number of flares 2 years prior Belimumab onset, number of medical visits, number of days of sick leave, type of disease, treatment and laboratory data. As a measure of damage, Systemic Lupus International Collaborating Clinics-Damage Index (SLICC-DI) score will be calculated at baseline and at 12, 18, 24 months and yearly of follow-up. All centers will be requested to provide the SLICC-DI calculated annually of the last five years before the initiation of belimumab, when available.

The efficacy will be evaluated as time to reach any of the definition of remission included in the DORIS (definitions of remission in SLE) consensus, or LLDAs (lupus low disease activity state). Regarding the safety of Belimumab in real-world setting, it will be defined and evaluated by documenting adverse events.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus; SLE; Belimumab

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Fundación Española de Medicina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerard Espinosa

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Locations

Hospital Clinic Barcelona

Barcelona, , Spain

Countries

Spain

Central Contacts

Almudena Sanchez Ledesma

Role: CONTACT

Phone: 0034915357183

Email: almudena.sanchez@shmedical.es

Facility Contacts

Gerard Espinosa

Role: primary

Other Identifiers

BeliLES

Identifier Type: -

Identifier Source: org_study_id