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BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus

NCT05624437 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2022-11-22

No results posted yet for this study

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)

Interventions

OTHER

data record

data record

Sponsors & Collaborators

  • Centre Hospitalier de Niort

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-19
Primary Completion
2021-11-19
Completion
2022-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05624437 on ClinicalTrials.gov