Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. (ASCLEPIOS II)
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| ClinicalTrials.gov Identifier: NCT02792231 |
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Recruitment Status :
Recruiting
First Posted : June 7, 2016
Last Update Posted : September 11, 2018
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| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Estimated Primary Completion Date : | May 15, 2019 |
| Estimated Study Completion Date : | May 15, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ofatumumab
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 |
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Active Comparator: Teriflunomide
Oral capsule 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
- 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
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of multiple sclerosis (MS)
- Relapsing MS (RRMS or SPMS) course
- At least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan in previous year
- EDSS score of 0 to 5.5
Exclusion Criteria:
- Primary progressive MS
- Disease duration of more than 10 years in patients with an EDSS score of 2 or less
- Patients with an active chronic disease of the immune system other than MS
- Patients at risk of developing or having reactivation of hepatitis
- Patients with active systemic infections or with neurological findings consistent with PML
Other protocol-defined inclusion/exclusion criteria may apply
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
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | ||
| Contact: Novartis Pharmaceuticals | +41613241111 |
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| Study Director: | Novartis Pharmaceuticals | Novartis |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02792231 History of Changes |
| Other Study ID Numbers: |
COMB157G2302 2015-005419-33 ( EudraCT Number ) |
| First Posted: | June 7, 2016 Key Record Dates |
| Last Update Posted: | September 11, 2018 |
| Last Verified: | September 2018 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Relapsing multiple sclerosis Ofatumumab |
Additional relevant MeSH terms:
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Sclerosis Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Ofatumumab Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |