BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus

SLE (Systemic Lupus) Clinical Trial

— BESST  

Official title:

BElimumab corticoSteroids Sparing Treatment in Systemic Lupus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05624437
• Other study ID #: CHNiort
• Status: Completed
• Start date: November 19, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2022
• Source: Centre Hospitalier de Niort
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

BELIMUMAB, anti-BLyS human monoclonal antibody, is the first immunotherapy used for the treatment of systemic lupus erythematosus (SLE) which was licensed in 2011 in France. Currently, Belimumab is reimbursed for the treatment of active SLEwith autoantibody-positive after intolerant or initial failure of first-line traitment (anti malaria, non-steroidal anti-inflammatory drugs, glucocorticoids and/ou immunomodulatory agents). EUropean League Against Rheumatism (EULAR) suggest the following terminology of "low dose" when steroids are less than 7.5 mg/day (prednisone equivalent) because this dose range is often used for maintenance therapy for many rheumatic diseases requiring glucocorticoids and it is relatively few adverse effects. In patients with SLE, a significant proportion of the damage could be attributed to corticosteroid therapy, and this damage accumulated over time. Thanks to randomised and subgroups trials, post-hoc analysis , BELIMUMAB seems to be interesting in the maintain of lowest possible dose of glucocorticoids. However, these studies were not design with this aim, so it is impossible to conclude. Thus, BELIMUMAB seems to be very interesting treatment to redcuce glucocorticoids level. We conduce a multicentric French study in real-life settings, to assess the ability of belimumab to achieve low-dose of steroids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 31, 2022
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• person aged = 18 years
• with SLE according to ACR/EULAR criteria 2019
• started treatment by BELIMUMAB between 13 / July / 2011 to 13 / July / 2020
• following in an hospital center in Poitiers, La Rochelle, Rochefort, Niort, Angoulême, Nantes, Rennes, Tours, Angers
• affiliate or beneficiary of a social security scheme

Exclusion Criteria:

• Persons Under guardianship or curatorship or without civil law
• Pregnant and breastfeeding
• Persons who refused to participate
• Patients who stoppped BELIMUMAB before 6 months

Related Conditions & MeSH terms

• SLE (Systemic Lupus)

Intervention

Other:
• data record
data record

Locations

Country	Name	City	State
France	CH Niort	Niort

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Niort

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients whith low dose of steroids at six months after BELIMUMAB	number of patients whith low dose of steroids at six months after BELIMUMAB	at six months after BELIMUMAB
Secondary	number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB	number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB	12, 18 and 24 months after BELIMUMAB
Secondary	cumulative dose of steroids at 6, 12, 18, 24 months	cumulative dose of steroids at 6, 12, 18, 24 months	6, 12, 18, 24 months