1
Participants
Start Date
December 23, 2015
Primary Completion Date
March 23, 2016
Study Completion Date
March 23, 2016
Ofatumumab
Ofatumumab (human monoclonal antibody) will be provided as a liquid concentrate in a prefilled glass syringe with staked needle, stopper, and plunger containing 0.4 millilitre (mL) (20 mg) drug product of 50 mg/mL concentration
Acetaminophen/paracetamol
Acetaminophen/paracetamol will be supplied by study centre as 1 gram tablet, caplet, capsule or liquid for oral administration
Antihistamine (cetirizine or equivalent)
Antihistamine (cetirizine or equivalent) will be supplied by study center as 10 mg tablet, caplet, capsule or liquid for oral administration
Prednisone/Prednisolone
Prednisone/Prednisolone will be supplied from the dose range 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 25, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180, 200, 220 and 240 mg for oral administration
GSK Investigational Site, Ann Arbor
GSK Investigational Site, Los Angeles
Lead Sponsor
GlaxoSmithKline
INDUSTRY