Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Brief Summary: Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both well tolerated and efficacious in several indications, including a small, placebo-controlled trial in RRMS using an intravenous (IV) formulation.

This double-blind, placebo-controlled, parallel-group study will investigate the safety and efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS. The primary objective of the study is to investigate the efficacy as assessed by magnetic resonance imaging. Other objectives will include evaluation of tolerability/safety, dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as other clinical endpoints.


Options:
A: Arm Label: GTR; Type: EXPERIMENTAL; Interventions: Drug: Glatiramer Acetate (GTR) | Arm Label: Copaxone®; Type: ACTIVE_COMPARATOR; Interventions: Drug: Glatiramer Acetate (Copaxone®) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Glatiramer Acetate (GTR); Assigned to Arm(s): GTR | Intervention Type: DRUG; Name: Glatiramer Acetate (Copaxone®); Assigned to Arm(s): Copaxone® | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Cohort 1; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab 3mg, Drug: Placebo | Arm Label: Cohort 2; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab 3mg, Drug: Placebo | Arm Label: Cohort 3.1; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab 30mg, Drug: Placebo | Arm Label: Cohort 3.2; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab 3mg, Drug: Ofatumumab 30mg, Drug: Placebo | Arm Label: Cohort 4.1; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab 60mg, Drug: Placebo | Arm Label: Cohort 4.2; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab 3mg, Drug: Ofatumumab 60mg, Drug: Placebo | Arm Label: Cohort 5.1; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab 60mg, Drug: Placebo | Arm Label: Cohort 5.2; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab 3mg, Drug: Ofatumumab 60mg | Intervention Type: DRUG; Name: Ofatumumab 3mg; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3.2, Cohort 4.2, Cohort 5.2 | Intervention Type: DRUG; Name: Ofatumumab 30mg; Assigned to Arm(s): Cohort 3.1, Cohort 3.2 | Intervention Type: DRUG; Name: Ofatumumab 60mg; Assigned to Arm(s): Cohort 4.1, Cohort 4.2, Cohort 5.1, Cohort 5.2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3.1, Cohort 3.2, Cohort 4.1, Cohort 4.2, Cohort 5.1
C: Arm Label: ALKS 8700; Type: EXPERIMENTAL; Interventions: Drug: ALKS 8700 | Arm Label: Dimethyl Fumarate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dimethyl Fumarate | Intervention Type: DRUG; Name: ALKS 8700; Assigned to Arm(s): ALKS 8700 | Intervention Type: DRUG; Name: Dimethyl Fumarate; Assigned to Arm(s): Dimethyl Fumarate
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: methylprednisolone, Drug: Placebo | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: methylprednisolone, Drug: Placebo | Intervention Type: DRUG; Name: methylprednisolone; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: methylprednisolone; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 1, 2

Answer: B