Ignite Creation Date:
2024-05-06 @ 10:08 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03177083
Status:
COMPLETED
Last Update Posted:
2020-11-25
First Post:
2017-01-26
Brief Title:
Evaluate SafetyTolerability in Portuguese Participants With RRMS Transitioning From Current Therapy
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
Open-label Randomized 2-arm Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis MS Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a PLEGRIDY
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLENO
Brief Summary:
The primary objective of the study is to evaluate safety and tolerability as defined by the frequency of the adverse events AEs of flu-like symptoms FLS chills pyrexia myalgia and asthenia injection site reactions ISRs and injection site reaction pain ISR-P over 24 weeks of treatment the active comparator period with PLEGRIDY 125 microgram μg subcutaneous SC every 2 weeks versus current SC IFN-β therapy in participants with Relapsing Remitting Multiple Sclerosis RRMS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-000434-21 | EUDRACT_NUMBER | None | None |