Lupus & antiphospholipid syndrome

Open-label, prospective, phase II descriptive pilot trial of belimumab therapy for refractory and/or non-criteria manifestations of antiphospholipid syndrome: study protocol

Clin Exp RheumatolPublished Study protocol for a phase II descriptive pilot trial

Study context

Population
Patients persistently positive for aPL with refractory and/or non-criteria manifestations of antiphospholipid syndrome (APS), San Giovanni Bosco Hospital (Turin)planned
Participants
15 participants
Primary endpoint
Safety and adverse events (safety and tolerability of belimumab given for 24 months)
Follow-up
4, 16, 24, 36, 52 and 104 weeks
Methodological detailsinvestigator-initiated, single-centre, open-label, prospective
  • Investigator-initiated
  • Single-centre
  • Open-label
  • Prospective

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Open-label, prospective, phase II descriptive pilot trial of belimumab therapy for refractory and/or non-criteria manifestations of antiphospholipid syndrome: study protocol. Clin Exp Rheumatol. Published 10 January 2022. doi:10.55563/clinexprheumatol/qa2yb4

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