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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05624437
Other study ID # CHNiort
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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