Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Brief Summary: The primary objective of the study is to determine which baseline and yearly response factors (clinical and para clinical) predict overall disease-free status at Month 12 and Month 24, and clinical disease-free status in subsequent Months 36 and 48. The secondary objectives are: To identify prognostic factors at Baseline that predict overall disease-free status at Month 12, and to assess if yearly overall disease-free response factors predict overall disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded Disability Status Scale \[EDSS\]) at each analysis time point of Months 12, 24, 36, and 48; To identify prognostic factors at Baseline that predict clinical disease-free status at Month 12, and to assess yearly clinical disease-free response factors that predict clinical disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: annualized relapse rate (ARR), sustained EDSS progression and improvement (24-week sustained); To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1 with Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month 48 on the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test \[SDMT\]), capacity for work (Work Productivity and Activity Impairment Questionnaire \[WPAI\]), quality of life (QoL) (Multiple Sclerosis Impact Scale \[MSIS-29\])


Options:
A: Arm Label: GA 40 mg / GA 40 mg; Type: EXPERIMENTAL; Interventions: Drug: Glatiramer acetate (GA) | Arm Label: Placebo / GA 40 mg; Type: PLACEBO_COMPARATOR; Interventions: Drug: Glatiramer acetate (GA), Drug: Placebo | Intervention Type: DRUG; Name: Glatiramer acetate (GA); Assigned to Arm(s): GA 40 mg / GA 40 mg, Placebo / GA 40 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo / GA 40 mg
B: Intervention Type: BIOLOGICAL; Name: natalizumab; Assigned to Arm(s): N/A
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: BG00012 plus placebo; Type: EXPERIMENTAL; Interventions: Drug: dimethyl fumarate, Drug: Placebo | Arm Label: BG00012; Type: EXPERIMENTAL; Interventions: Drug: dimethyl fumarate | Intervention Type: DRUG; Name: dimethyl fumarate; Assigned to Arm(s): BG00012, BG00012 plus placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BG00012 plus placebo

Answer: B