Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04671706 |
| Other study ID # |
BeliLES |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2021 |
| Est. completion date |
December 2026 |
Study information
| Verified date |
December 2020 |
| Source |
Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Fundación Española de Medicina |
| Contact |
Almudena Sanchez Ledesma |
| Phone |
0034915357183 |
| Email |
almudena.sanchez[@]shmedical.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
