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Completed

NCT Number: NCT05624437

BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus

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.

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Key information

Conditions

SLE (Systemic Lupus) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Niort

Niort, 79021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

data record

Other

data record

Primary outcomes

  1. number of patients whith low dose of steroids at six months after BELIMUMAB

    Time frame: at six months after BELIMUMAB

    number of patients whith low dose of steroids at six months after BELIMUMAB

Secondary outcomes

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

    Time frame: 12, 18 and 24 months after BELIMUMAB

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

  2. cumulative dose of steroids at 6, 12, 18, 24 months

    Time frame: 6, 12, 18, 24 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Niort

Other

Registry information

Official study title

BElimumab corticoSteroids Sparing Treatment in Systemic Lupus

Acronym: BESST

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 22, 2022
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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