The objective of this study is to assess the safety and tolerability of sifalimumab in adult participants with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) who participated in the following clinical studies: MI-CP151, MI-CP152, or MI-CP179.
The primary objective of this study is to evaluate the long-term safety and tolerability of multiple intravenous (IV) doses of sifalimumab in adult participants with active SLE or DM or PM who were previously treated with investigational product (sifalimumab or placebo) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
118
All participants will receive intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg is increased to 600 mg with subsequent protocol amendment.
Research Site
Anniston, Alabama, United States
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: From start of study drug administration until week 182
Maximum Observed Serum Concentration (Cmax) for Sifalimumab
The Cmax is the maximum observed plasma concentration of sifalimumab.
Time frame: Pre-infusion and End of Infusion on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab
The Tmax is the time to reach maximum observed plasma concentration of sifalimumab.
Time frame: Pre-infusion and End of Infusion on Day 1
Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab
The Tlast is the time to last quantifiable plasma concentration (Tlast) of sifalimumab.
Time frame: Pre-infusion and End of Infusion on Day 1
Minimum Observed Serum Concentration (Ctrough) of Sifalimumab
The Ctrough is the minimum observed serum concentration of sifalimumab.
Time frame: Pre-infusion and End of Infusion on Day 1
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Research Site
Scottsdale, Arizona, United States
Research Site
San Leandro, California, United States
Research Site
Upland, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Baltimore, Maryland, United States
Research Site
Cumberland, Maryland, United States
...and 18 more locations
Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab
The AUCtau is the area under the serum concentration-time curve over the dosing interval of sifalimumab.
Time frame: Pre-infusion and End of Infusion on Day 1
Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab
The Ctrough is the minimum observed serum concentration at steady state of sifalimumab.
Time frame: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168
Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab
The Ctrough is the minimum observed serum concentration of sifalimumab. Accumulation Index is calculated as Ctrough value at steady state divided by Ctrough value after first dose.
Time frame: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168
Number of Participants With Positive Anti-Drug Antibody
Participants tested for immunogenicity to Sifalimumab (MEDI-545) from Day 1 to the end of study.
Time frame: Day 1 and Week 12, 24, 52, 104, 156 and 168