Status:
COMPLETED
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Biogen
Collaborating Sponsors:
AbbVie
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components: * An assessment of safety a...
Detailed Description
This study, an extension to Study 205MS201 (NCT00390221), will evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in MS. In Study 205MS201, study treatment was scheduled to stop at...
Eligibility Criteria
Inclusion
- Key
- Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator.
- Key
Exclusion
- Subjects with any significant change in their medical status from 205MS201 that would preclude administration of DAC HYP, as determined by the Investigator
- Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo
- Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant interferon-beta
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
517 Patients enrolled
Trial Details
Trial ID
NCT00870740
Start Date
February 1 2009
End Date
October 1 2012
Last Update
August 30 2016
Active Locations (58)
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1
Research Site
Brno, Czechia
2
Research Site
Hraddec Kralove, Czechia
3
Research Site
Olomouc, Czechia
4
Research Site
Pilsen, Czechia