Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. (ASCLEPIOS II)
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|ClinicalTrials.gov Identifier: NCT02792231|
Recruitment Status : Active, not recruiting
First Posted : June 7, 2016
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsing Multiple Scelrosis||Drug: Ofatumumab subcutaneous injection Drug: Placebo orally matching to teriflunomide Drug: Teriflunomide orally Drug: Placebo subcutaneous injection matching to ofatumumab||Phase 3|
This is a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multicenter study with variable treatment duration in approximately 900 patients with relapsing MS. The maximal treatment duration in the study for an individual patient will be 2.5 years.
Eligible patients will be randomized to receive either experimental ofatumumab subcutaneous (sc) injections every 4 weeks or active comparator teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.|
|Actual Study Start Date :||August 26, 2016|
|Actual Primary Completion Date :||July 10, 2019|
|Estimated Study Completion Date :||March 27, 2020|
Syringes for subcutaneous injection
Patients will also take a placebo capsule (matching in appearance to teriflunomide)
Drug: Ofatumumab subcutaneous injection
Patients randomized to the ofatumumab arm will receive subcutaneous injections of ofatumumab every 4 weeks
Drug: Placebo orally matching to teriflunomide
Placebo orally, matching in appearance to teriflunomide, administered once daily
Active Comparator: Teriflunomide
Patients will also take subcutaneous injections of placebo (syringes matching in appearance to ofatumumab)
Drug: Teriflunomide orally
Patients randomized to the teriflunomide arm will take teriflunomide orally once daily
Other Name: Aubagio
Drug: Placebo subcutaneous injection matching to ofatumumab
Placebo-containing syringes, matching in appearance to syringes containing ofatumumab, administered every 4 weeks
- Annualized relapse rate (ARR) [ Time Frame: up to 2.5 years ]ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient
- Time to 3-month confirmed disability worsening on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]A 3-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3 months.
- Time to 6-month confirmed disability worsening on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]A 6-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 6 months.
- Time to 6-month confirmed disability improvement on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]A 6-month confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months.
- Number of gadolinium (Gd)-enhancing lesions per MRI scan [ Time Frame: Baseline, yearly up to 2.5 years ]Total number of Gd-enhancing lesions across all scans per patient adjusted for different number of scans due to variable follow up time in study
- Number of new or enlarging T2 lesions on MRI per year (annualized lesion rate) [ Time Frame: Baseline, yearly up to 2.5 years ]Number of new/enlarging T2 lesions on last available MRI scan compared to baseline adjusted for different time of scans versus baseline due to variable follow up time in study
- Neurofilament light chain (Nfl) concentration in serum [ Time Frame: Baseline, every 3 months up to 2.5 years ]The NfL concentration (geometric mean concentration) will be estimated by treatment and time point with using a repeated measures model on the basis of all evaluable log-transformed NfL values.
- Rate of brain volume loss based on assessments of percentage brain volume change from baseline [ Time Frame: Baseline, yearly up to 2.5 years ]Percent change from baseline in brain volume loss (BVL) on all MRI scans adjusted for different time of scan versus baseline due to variable follow up time in study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792231
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|Study Director:||Novartis Pharmaceuticals||Novartis|