An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study
- Conditions
- MedDRA version: 9.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisRelapsing multiple sclerosis
- Registration Number
- EUCTR2008-005021-11-FR
- Lead Sponsor
- Merck Serono International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
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 for Participation in Study 28851:
- Premature discontinuation of core study 28063.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method