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NCT05659407: PREDICT
BAFF-var as a Biomarker of Response to B-depletive Treatment in Systemic Lupus Erythematosus and Rheumatoid Arthritis
trial testing Belimumab in SLE patients / Rituximab in RA patients in Systemic Lupus Erythematosus in 60 participants. Status unknown.
31 January 2023
Quick facts
| Lead sponsor | University of Cagliari |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 24 July 2020 |
| Primary completion | 31 January 2023 |
| Estimated completion | 31 January 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Belimumab in SLE patients / Rituximab in RA patients — full drug profile →
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- BLyS Polymorphism — all drugs for BLyS Polymorphism →
Sponsor
University of Cagliari
Who can join
18 and older, any sex, with Systemic Lupus Erythematosus or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A variant of the TNFSF13B gene, commonly referred to as BAFF-var has been associated with an increased risk of developing immune-mediated diseases, such as Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA). This polymorphism leads to the production of higher levels of BAFFs, that in turns are associated with more severe disease, high anti-Sm and anti-dsDNA titre, complement consumption, and increased risk of flare in SLE, and higher disease activity in RA. This is a prospective study aiming to explore the immunological basis of a potential role of BAFF-var as a prognostic biomarker for response to belimumab and rituximab, the main B-depletive treatments, in SLE and RA patients, respectively. More in detail, the study aims to evaluate if the condition of BAFF-var carrier in SLE and RA patients, treated respectively, with belimumab plus standard of care or rituximab influences immunological, molecular and clinical variables, such as: (a) soluble BAFF (BAFFs) cytokine, (b) mRNA-BAFF (c) miRNA-15a (d) B-cell subpopulations (d) disease activity, as assessed by standardized clinimetric tools.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05659407
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05659407 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Cagliari
- Last refreshed: 21 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05659407.
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