Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788615
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2021-03-08
Brief Title:
Open Label Randomized Multicenter to Assess Efficacy Tolerability of Ofatumumab 20mg vs First Line DMT in RMS
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs First Line DMT - Physicians Choice in the Treatment of Newly Diagnosed RMS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
STHENOS
Brief Summary:
This study will compare ofatumumab vs European approved platform first line self-administered disease modifying therapy DMT in newly diagnosed MS patients
Detailed Description:
The study is a randomized 11 open-label rater-blind multi-center prospective parallel-arm active comparator study which will consist of 15 months treatment period and a 6 months observational safety extension period for patients who withdraw ofatumumab for any reason in 186 total patients with early relapsing multiple sclerosis RMS RMS patients are patients who are newly diagnosed or have never been on active treatment at the time of study entry with 5 years from first MS symptoms
There is a screening period and patients are randomized to either ofatumumab or first line DMT at baseline Patients will be treated until the end of study EOS or for a maximum duration of 15 months Patients who prematurely discontinue study drug or comparator will have their end of treatment EOT visit and assessments at the time of discontinuation After ofatumumab or the standard of care comparator DMT discontinuation patients may initiate alternative MS therapy according to local standard of care if clinically indicated
Patients who for any reason withdraw from ofatumumab during treatment will be invited to participate in the observational extension safety period for 6 months or until patient re-starts MS treatment with a new DMT treatment During this period clinical efficacy after ofatumumab withdrawal will be assessed
There is a screening period and patients are randomized to either ofatumumab or first line DMT at baseline Patients will be treated until the end of study EOS or for a maximum duration of 15 months Patients who prematurely discontinue study drug or comparator will have their end of treatment EOT visit and assessments at the time of discontinuation After ofatumumab or the standard of care comparator DMT discontinuation patients may initiate alternative MS therapy according to local standard of care if clinically indicated
Patients who for any reason withdraw from ofatumumab during treatment will be invited to participate in the observational extension safety period for 6 months or until patient re-starts MS treatment with a new DMT treatment During this period clinical efficacy after ofatumumab withdrawal will be assessed
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 |
|---|---|---|---|
| 2020-004505-32 | EUDRACT_NUMBER | None | None |