Relapsing multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Sponsors
Merck Serono SA - Geneva, An affiliate of Merck KGaA, Darmstadt, Germany
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Participation in Study 28851: - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Participation in Study 28851: - Premature discontinuation of core study 28063.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to monitor the long-term safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS).;Secondary Objective: - To describe the long-term course of measures of MS disease activity and progression, such as relapse activity and EDSS, under atacicept treatment in subjects with RMS. - To describe the long-term effects of atacicept treatment on inflammation and CNS tissue integrity as measured by magnetic resonance imaging (MRI). - To study atacicept’s long-term biological activity by the assessment of pharmacodynamic (PD) and pharmacogenomic markers. - To explore atacicept’s immunogenicity, in particular the potential late development and persistence of neutralizing antibodies. ;Primary end point(s): Parameters related to the main study objective: - Nature and severity of adverse events (AEs) and serious AEs (SAEs), in particular infections and malignancies. - Hematology and blood chemistry laboratory parameters. - Injection site reactions. - Vital signs, ECGs. - IgG levels, in particular IgG level <3 g/L at any time during the study. - Immunogenicity: development of NAb to atacicept, persistence of NAb in subjects who become NAb-positive either in the core study or in the extension study (if this occurs). | — |
Countries
Belgium, Czech Republic, France, Sweden
Outcome results
None listed