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Synergetic B-cell Immunomodulation in SLE - 2nd Study.

NCT03747159 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-10-17

No results posted yet for this study

Summary

In follow-up of the previous SynBioSe Study the present study is a randomized controlled trial designed to further investigate the long-term clinical and imunological efficacy of combination B-cell targeting by starting treatment with belimumab (anti-BAFF) followed by rituximab(anti-CD20) in lupus nephritis patients.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

Belimumab Injection

Weekly injection of belimumab prior to two infusions of rituximab with continuation of the belimumab as maintenance therapy

Sponsors & Collaborators

  • Dutch Kidney Foundation

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Dr. Y.K.O. Teng, MD, PhD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2024-06-07
Completion
2026-06-07

Countries

  • Netherlands

Study Locations

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Entities

Companies

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 NCT03747159 on ClinicalTrials.gov