Synergetic B-cell Immodulation in SLE

Sponsor
Leiden University Medical Center
Study ID
NCT02284984
Phase
PHASE2
Status
Completed

Conditions

  • Lupus Erythematosus, Systemic

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab with belimumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2014
Status verified
Feb 2019
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab with belimumab
    Rituximab 1000mg on day 0 and day 14 Belimumab 10mg/kg on day 28, day 42 and day 56. Thereafter, patients will receive Belimumab 10mg/kg every 4 weeks.

Primary Outcome Measure

Reduction of pathogenic autoantibodies [ Time Frame: 24 weeks ]

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