NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Systemic Lupus Erythematosus
Date of first enrollment	28/01/2010
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : MEDI-545 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Single dose and multiple doses once every 2 weeks for 24 weeks

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	-Patients must have previously met 4 or more of the 11 revised ACR criteria -Have positive antinuclear antibody test (ANA) at 1:80 serum dilute or more in the past or at screening -Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score 6 or more
Exclude criteria	-Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1) -Have received the following medications within 28 days before Visit 2 (Day 1): - Systemic cyclophosphamide at any dose - Cyclosporine at any dose - Tacrolimus at any dose - Thalidomide at any dose - Mycophenolate mofetil >2 g/day - Methotrexate >15 mg/week - Azathioprine >2 mg/kg/day -Women who have a positive pregnancy test (serum hCG) at Visit 1