Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I)

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ClinicalTrials.gov Identifier: NCT02792218

Recruitment Status : Active, not recruiting

First Posted : June 7, 2016

Last Update Posted : April 24, 2018

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

Condition or disease	Intervention/treatment	Phase
Relapsing Multiple Sclerosis	Drug: Ofatumumab subcutaneous injection Drug: Placebo orally matching to teriflunomide Drug: Teriflunomide orally Drug: Placebo subcutanous injection matching to ofatumumab	Phase 3

Detailed Description:

This is a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multi-center 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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	928 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 :	September 19, 2016
Estimated Primary Completion Date :	May 15, 2019
Estimated Study Completion Date :	May 16, 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Teriflunomide Ofatumumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ofatumumab Syringes for subcutaneous injection Patients will also take a placebo capsules (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 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 subcutanous injection matching to ofatumumab Placebo-containing syringes, matching in appearance to syringes containing ofatumumab, administered every 4 weeks

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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): NCT02792218

Show 204 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02792218 History of Changes
Other Study ID Numbers:	COMB157G2301 2015-005418-31 ( EudraCT Number )
First Posted:	June 7, 2016 Key Record Dates
Last Update Posted:	April 24, 2018
Last Verified:	April 2018


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Relapsing multiple sclerosis Ofatumumab

Additional relevant MeSH terms:


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

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