The NASA Mission Operations and Control Architecture Program

The conflict between increases in space mission complexity and rapidly declining space mission budgets has created strong pressures to radically reduce the costs of designing and operating spacecraft. A key approach to achieving such reductions is through reducing the development and operations costs of the supporting mission operations systems. One of the efforts which the Communications and Data Systems Division at NASA Headquarters is using to meet this challenge is the Mission Operations Control Architecture (MOCA) project. Technical direction of this effort has been delegated to the Mission Operations Division (MOD) of the Goddard Space Flight Center (GSFC). MOCA is to develop a mission control and data acquisition architecture, and supporting standards, to guide the development of future spacecraft and mission control facilities at GSFC. The architecture will reduce the need for around-the-clock operations staffing, obtain a high level of reuse of flight and ground software elements from mission to mission, and increase overall system flexibility by enabling the migration of appropriate functions from the ground to the spacecraft. The end results are to be an established way of designing the spacecraft-ground system interface for GSFC's in-house developed spacecraft, and a specification of the end to end spacecraft control process, including data structures, interfaces, and protocols, suitable for inclusion in solicitation documents for future flight spacecraft. A flight software kernel may be developed and maintained in a condition that it can be offered as Government Furnished Equipment in solicitations. This paper describes the MOCA project, its current status, and the results to date

Safety and Dose-Response of Vidofludimus Calcium in Relapsing Multiple Sclerosis: Extended Results of a Placebo-Controlled Phase 2 Trial

BACKGROUND AND OBJECTIVES: Vidofludimus calcium suppressed MRI disease activity compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS) in the first cohort of the phase 2 EMPhASIS study. Because 30 mg and 45 mg showed comparable activity on multiple end points, the study enrolled an additional low-dose cohort to further investigate a dose-response relationship. METHODS: In a randomized, placebo-controlled, phase 2 trial, patients with RRMS, aged 18-55 years, and with ≥2 relapses in the last 2 years or ≥1 relapse in the last year, and ≥1 gadolinium-enhancing brain lesion in the last 6 months. Patients were randomly assigned (1:1:1) vidofludimus calcium (30 or 45 mg) or placebo in cohort 1 and vidofludimus calcium (10 mg) or placebo (4:1) in cohort 2 for 24 weeks. The primary end point was the cumulative number of combined unique active (CUA) lesions at week 24. Secondary end points were clinical outcomes and safety. RESULTS: Across cohorts 1 and 2, 268 patients were randomized to placebo (n = 81), 10 mg (n = 47) vidofludimus calcium, 30 mg (n = 71) vidofludimus calcium, or 45 mg (n = 69) vidofludimus calcium. The mean cumulative CUA lesions over 24 weeks was 5.8 (95% CI 4.1-8.2) for placebo, 5.9 (95% CI 3.9-9.0) for 10 mg treatment group, 1.4 (95% CI 0.9-2.1) for 30 mg treatment group, and 1.7 (95% CI 1.1-2.5) for 45 mg treatment group. Serum neurofilament light chain decreased in a dose-dependent manner. The number of patients with confirmed disability worsening after 24 weeks was 3 (3.7%) patients receiving placebo and 3 (1.6%) patients receiving any dose of vidofludimus calcium. Treatment-emergent adverse events occurred in 35 (43%) placebo patients compared with 11 (23%) and 71 (37%) patients in the 10 mg or any dose of vidofludimus calcium groups, respectively. The incidence of liver enzyme elevations and infections were similar between placebo and any dose of vidofludimus calcium. No new safety signals were observed. DISCUSSION: Compared with placebo, vidofludimus calcium suppressed the development of new brain lesions with daily doses of 30 mg and 45 mg, but not 10 mg, establishing the lowest efficacious dose is 30 mg. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that among adults with active RRMS and ≥1 Gd+ brain lesion in the past 6 months, the cumulative number of active lesions decreased with vidofludimus calcium. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov (NCT03846219) and EudraCT (2018-001896-19)