What we are studying
If you agree to participate in the study by signing this consent form, your Study Doctor will have up to 45 days to complete tests to see if you are eligible to enter the study. This is called “screening”. The screening period will require two visits to the study site : one initial screening visit and a second “baseline” visit. Over the course of these two visits, your Study Doctor will ask you some questions about your health, your medical history and about any medications you have been taking.
During the study treatment period, you will receive either ofatumumab or teriflunomide. Since ofatumumab is taken as an injection (provided as prefilled syringes of 0.4 mL) and teriflunomide as a pill (a capsule), researchers must have a way to prevent you or the Study Doctor from knowing which drug you are on. For that reason, you will be taking a pill (capsule) daily, and injections every month. No matter which drug group you are assigned to, you will be taking one real drug, and one “dummy” drug. If you are assigned to the group taking the real ofatumumab (which is injected), you will also have to take pills every day even though they are an inactive “placebo”. Likewise, if you are assigned to the group taking the real teriflunomide (which is a pill), you will still have to take injections but they will only be filled with sterile liquid. In this way, the study remains “blinded” and neither you nor your Study Doctor will know which drug you are on. This entire procedure, to help make sure you cannot tell if you are assigned to take ofatumumab or teriflunomide, is called “double -blind, double-dummy” masking of the treatments.
You will be assigned to one of the two treatment groups below:
• Ofatumumab (20 mg subcutaneous injection at Day 1, 7, 14 and Day 28 and then once every 4 weeks) AND one capsule of placebo (‘inactive capsule’) taken orally daily (this is called the ‘ofatumumab group’)
• Teriflunomide (14 mg capsule taken orally daily) AND a subcutaneous injection of placebo (‘inactive injection’) at Day 1, 7, 14 and Day 28 and then once every 4 weeks (this is called the ‘teriflunomide group’).
You will be paid $1600.00 if you complete all the scheduled study visits. If you withdraw for any reason from the study before completion you will be paid $100.00 for each complete study visit.