MedTrace Logo

Synergetic B-cell Immodulation in SLE

NCT02284984 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-02-28

No results posted yet for this study

Summary

The present study investigates the potential of a new therapeutic approach in lupus nephritis combining rituximab (anti-CD20) and belimumab (anti-BAFF). The main goal of the study is to assess the reduction (and seroconversion) of pathogenic autoantibodies, to evaluate clinical improvement and assess the safety and feasibility of long-term B-cell depletion.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

Rituximab with belimumab

Rituximab treatment on dag 0 and 14, 1000mg iv Belimumab 10mg/kg on day 28, day 42 and day 56. Thereafter, patients will receive Belimumab 10mg/kg every 4 weeks through 72 weeks.

Sponsors & Collaborators

  • Dutch Kidney Foundation

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Onno YK Teng, MD, PhD · Leiden University Medical Center

  • A J Rabelink, MD, PhD · Leiden University Medical Center

  • T WJ Huizinga, MD, PhD · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT02284984 on ClinicalTrials.gov