AIM: The primary objective of the BeLimumab Antiphospholipid Syndrome Trial (BLAST) is to evaluate the safety and tolerability of belimumab for up to 24 months in patients with persistent aPL positivity and clinical features attributable to aPL that are resistant to warfarin and/or heparin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
INTERVENTION DRUG: BELIMUMAB 10 MG/KG
San Giovanni Bosco Hospital
Turin, Piedmont, Italy
RECRUITINGNumber of Participants Experiencing Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 104 weeks
The Efficacy of Belimumab-thrombocytopenia
Outcome measures scored as complete response (CR), partial (PR), and none (NR) at 24, 52, 104 weeks. For thrombocytopenia, CR defined as a platelet count of ≥150×109/μl,PR as 100-149,and NR as \<100.
Time frame: 104 weeks
The Efficacy of Belimumab-CVD
Outcome measures scored as complete response (CR), partial (PR), and none (NR) at 24, 52, 104 weeks.For CVD,CR defined as the disappearance of cardiac lesions, PR as 50%improvement,and NR as no change.
Time frame: 104 weeks
The Efficacy of Belimumab-renal involvement
Outcome measures scored as complete response (CR), partial (PR), and none (NR) at 24, 52, 104 weeks. For aPL nephropathy, CR defined as a normal serum creatinine level, inactive urinary sediment, and urinary protein: creatinine 0.5;PR as a serum cr level 15% above baseline, RBCs per high-power field 50% above baseline with no casts, 50%improvement in the urinary prt:cr, and estimated GFR 10%above baseline; and NR as the absence of C/PR.
Time frame: 104 weeks
The Efficacy of Belimumab-cognitive impairment
Outcome measures scored as complete response (CR), partial (PR), and none (NR) at 24, 52, 104 weeks. For cognitive dysfunction,CR defined as normalization of the cognitive impairment index with 50%improvement,PR as abnormal index with 50%, and NR as no change.
Time frame: 104 weeks
The Efficacy of Belimumab-thrombosis
Rate of documented thrombotic events
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Time frame: 104 weeks
Change in aPL profile
Change in aPL levels at 24, 52, 104 weeks
Time frame: 104 weeks