Synergetic B-cell Immunomodulation in SLE - 2nd Study.
Netherlands70 participantsStarted 2018-10-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Have a clinical diagnosis of SLE according to the SLICC criteria 2012
ā. Severe, active SLE disease defined as a situation in which 1 or more of the following criteria are met:
ā. SLEDAI-2K (SLE Disease Activity Index) with 12 or more points
ā. New or worse SLE-related activity of major organs, i.e.: CNS-SLE (includes NPSLE), vasculitis, nephritis, pericarditis and/or myocarditis, myositis, thrombocytopenia \< 60, hemolytic anemia \< 4.4mmol/L (=7.0g/dL)
ā. high disease activity that requires or warrants induction treatment by switching to or increasing dosage of oral mycophenolate
ā. New, persisting or progressive disease activity despite the use of conventional maintenance immunosuppressive treatment (e.g. mycophenolate or azathioprine)
ā. Positive for relevant SLE-specific autoantibodies defined as a situation in which 1 or more of the following criteria are met:
ā. ANA seropositivity, as defined by a positive ANA-titer ā„ 1:80, before and at screening :
Exclusion criteria
ā. Active pregnancy, as proven by a positive urine beta-HCG test or a positive serum beta-HCG
ā. Significant hypogammaglobulinemia (IgG \< 4.0 g/L) or an IgA deficiency (IgA \< 0.1 g/L)
ā. Immunization with a live vaccine 1 month before screening