Atacicept in Multiple Sclerosis Extension Study, Phase II
An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)
Sponsor: EMD Serono + Merck KGaA, Darmstadt, Germany
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity
Time frame: From the first dose of study drug administration up to Week 24
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36
Change From Baseline in Vital Signs: Pulse Rate
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36
Change From Baseline in Vital Signs: Temperature
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36
Secondary Endpoints
Number of Subjects With Clinical Attacks/Relapses
Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12
Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12
Eligibility Criteria
Inclusion Criteria: * Participation in study 28063. * Completion of Week 36 visit of the core study 28063. * Willingness and ability to comply with study procedures for the duration of the study. * Voluntary provision of written informed consent (including, for the USA, subject authorization under the Health Insurance Portability and Accountability Act (HIPAA)), given before any study-related procedure that is not part of normal medical care and with the understanding that the subject may withdraw consent at any time without prejudice to his or her future medical care. Exclusion Criteria: * Premature discontinuation of core study 28063. * Subjects who meet criteria listed below will receive IMP in study 28851: * Subjects who are eligible for participation in extension study 28851 but do not meet these criteria will not be treated with IMP but will undergo scheduled visits, irrespective of their treatment. * All subjects must satisfy the following criteria before Extension Study D…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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