BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus

NCT05624437 | Completed

• 1 other identifier: CHNiort
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SLE (Systemic Lupus)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB

  12, 18 and 24 months after BELIMUMAB

• cumulative dose of steroids at 6, 12, 18, 24 months

  6, 12, 18, 24 months

Interventions

data record OTHER

data record

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier de Niort: lead

Study Sites (1)

CH Niort

Niort, 79021, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: November 22, 2022
• Study Start: November 19, 2021
• Primary Completion: November 19, 2021
• Study Completion: August 31, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

FR (1)