Transcriptional and Immune Parameters of Response to Belimumab

Plain-language summary

This study examines the gene-expression (transcriptional) and immune markers of response to Belimumab in patients with systemic lupus erythematosus. It enrolled adults over 18 with active disease who were started on Belimumab. The study was conducted as a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Biomedical Research Foundation, Academy of Athens

Intervention

Belimumab

Start date

12/16/2020

Estimated completion

12/16/2023

Countries

Greece

Related genes

Locations

• Athens, Greece

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria: SLE patients:

* who meet the Systemic Lupus International Collaborating Clinics (SLICC) 2012 and/or European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria;
* have active disease defined as the combination of clinical (i.e., excluding serology) SLEDAI-2000 ≥6 and/or physician global assessment (PhGA) ≥1.5. Both flaring (acute exacerbation) and persistent disease activity will be considered;
* are started belimumab (standard approved dose of i.v. 10 mg/kg or subcutaneous 200 mg/week) due to active disease. The intention to start belimumab will be made by the treating Rheumatologist(s), in accordance to the current standard of care, and on the basis of shared physician-patient decision making.

Exclusion Criteria:

* age \<18 years
* co-existing rheumatic or other autoimmune disease
* pregnancy
* active infection
* history of malignant disorder