Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults. The management of MS-patients requires treatment with disease-modifying agents, monoclonal antibodies such as natalizumab or immunosuppressants. Natalizumab showed good efficacy and is approved for treatment of relapsing MS with a number of restrictions due to safety issues. Cognitive data related to natalizumab treatment are still scarce. Interferon-beta-1b is approved for high-frequency, subcutaneous (sc) administration in the treatment of multiple sclerosis. It reduces the relapse rate, severity, hospitalisation and the disease activity as seen on MRI.

This is a pilot study to explore the concept of de-escalating natalizumab treatment to interferon-beta-1b e.o.d compared to continuous treatment with natalizumab in patients with relapsing-remitting multiple sclerosis previously treated with natalizumab for 12 months. The study is designed as prospective, controlled, randomized, rater-blinded, parallel-group, two arm, mono-centric including patients of the Ticino Cohort. One arm will be treated with Interferon-beta 1b 250mcg given subcutaneously every other day, the other with Natalizumab 300 mg given intravenously (i.v.), every four weeks. The treatment duration is 12 months, the follow-up period 12 months. The time to first on-study relapse will be compared between the to treatment arms (primary outcome). Other efficacy parameter include clinical and radiological parameters, patient reported outcome on quality of life and fatigue. Safety is assessed by reports of adverse events.


Options:
A: Arm Label: Ozanimod 0.5 mg; Type: EXPERIMENTAL; Interventions: Drug: Ozanimod, Drug: Interferon beta-1a placebo | Arm Label: Ozanimod1 mg; Type: EXPERIMENTAL; Interventions: Drug: Ozanimod, Drug: Interferon beta-1a placebo | Arm Label: Interferon β-1a; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ozanimod placebo, Drug: Interferon beta-1a | Intervention Type: DRUG; Name: Ozanimod; Assigned to Arm(s): Ozanimod 0.5 mg, Ozanimod1 mg | Intervention Type: DRUG; Name: Ozanimod placebo; Assigned to Arm(s): Interferon β-1a | Intervention Type: DRUG; Name: Interferon beta-1a; Assigned to Arm(s): Interferon β-1a | Intervention Type: DRUG; Name: Interferon beta-1a placebo; Assigned to Arm(s): Ozanimod 0.5 mg, Ozanimod1 mg
B: Arm Label: Natalizumab; Type: ACTIVE_COMPARATOR; Interventions: Drug: Natalizumab | Arm Label: Interferon-beta-1b; Type: EXPERIMENTAL; Interventions: Drug: interferon beta-1b | Intervention Type: DRUG; Name: interferon beta-1b; Assigned to Arm(s): Interferon-beta-1b | Intervention Type: DRUG; Name: Natalizumab; Assigned to Arm(s): Natalizumab
C: Arm Label: Alemtuzumab 12 mg; Type: EXPERIMENTAL; Interventions: Biological: Alemtuzumab 12 mg | Arm Label: Alemtuzumab 24 mg; Type: EXPERIMENTAL; Interventions: Biological: Alemtuzumab 24 mg | Arm Label: Interferon Beta-1a; Type: ACTIVE_COMPARATOR; Interventions: Biological: Interferon beta-1a | Intervention Type: BIOLOGICAL; Name: Alemtuzumab 12 mg; Assigned to Arm(s): Alemtuzumab 12 mg | Intervention Type: BIOLOGICAL; Name: Alemtuzumab 24 mg; Assigned to Arm(s): Alemtuzumab 24 mg | Intervention Type: BIOLOGICAL; Name: Interferon beta-1a; Assigned to Arm(s): Interferon Beta-1a
D: Arm Label: OMB 20 mg; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab subcutaneous injection, Drug: Teriflunomide-matching placebo capsules | Arm Label: TER 14 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Teriflunomide capsule, Drug: Matching placebo of ofatumumab subcutaneous injections | Intervention Type: DRUG; Name: Ofatumumab subcutaneous injection; Assigned to Arm(s): OMB 20 mg | Intervention Type: DRUG; Name: Teriflunomide-matching placebo capsules; Assigned to Arm(s): OMB 20 mg | Intervention Type: DRUG; Name: Teriflunomide capsule; Assigned to Arm(s): TER 14 mg | Intervention Type: DRUG; Name: Matching placebo of ofatumumab subcutaneous injections; Assigned to Arm(s): TER 14 mg

Answer: B