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Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.

NCT ID: NCT02792231

Last Updated: 2021-11-22

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

955 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-26

Study Completion Date

2020-10-22

Brief Summary

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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

Detailed Description

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This was a randomized, double-blind, double-dummy, active comparatorcontrolled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing multiple sclorosis (RMS). The maximal treatment duration in the study for an individual patient was 2.5 years. Eligible patients were randomized to receive either experimental ofatumumab subcutaneous (s.c.) injections every 4 weeks or active comparator teriflunomide orally once daily. The dose regimen for ofatumumab for this study was a loading dose regimen of 20 mg at Day 1, Day 7 and Day 14, followed by a maintenance dose regimen of 20 mg administered every 4 weeks starting at Week 4. In order to blind for the different formulations, double-dummy masking was used, i.e., all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).

Conditions

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Relapsing Multiple Scelrosis

Keywords

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Relapsing multiple sclerosis Ofatumumab adult OMB157 multiple sclerosis T1 lesions T2 lesions relapse GD-enhancing MRI McDonald criteria RRMS SPMS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OMG 20 mg

Ofatumumab 20 mg pre-filled syringes for subcutaneous injectionon on days 1

,7 ,14, week 4 and every 4 weeks thereafter and a teriflunomide-matching placebo, taken orally once daily

Group Type EXPERIMENTAL

Ofatumumab subcutaneous injection

Intervention Type DRUG

Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter

Teriflunomide-matching placebo capsules

Intervention Type DRUG

Placebo capsule, matching in appearance to teriflunomide, taken orally once daily

TER 14 mg

Teriflunomide 14 mg oral capsule taken once daily and matching placebo for subcutaneous injections to ofatumumab on days 1, 7, 14, week 4 and every 4 weeks thereafter

Group Type ACTIVE_COMPARATOR

Teriflunomide capsule

Intervention Type DRUG

Teriflunomide 14 mg oral capsule taken once daily

Matching placebo of ofatumumab subcutaneous injections

Intervention Type DRUG

Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter

Interventions

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Ofatumumab subcutaneous injection

Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter

Intervention Type DRUG

Teriflunomide-matching placebo capsules

Placebo capsule, matching in appearance to teriflunomide, taken orally once daily

Intervention Type DRUG

Teriflunomide capsule

Teriflunomide 14 mg oral capsule taken once daily

Intervention Type DRUG

Matching placebo of ofatumumab subcutaneous injections

Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients aged 18 to 55 years at Screening
* Diagnosis of multiple sclerosis (MS)
* Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with disease activity
* Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior to randomization
* Disability status at Screening with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5
* Neurologically stable within 1 month prior to randomization

Exclusion Criteria

* Patients with primary progressive MS or SPMS without disease activity
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

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Cullman, Alabama, United States

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Tucson, Arizona, United States

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Aurora, Colorado, United States

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Basalt, Colorado, United States

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Boulder, Colorado, United States

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Centennial, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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Fort Collins, Colorado, United States

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Fairfield, Connecticut, United States

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Newark, Delaware, United States

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Bradenton, Florida, United States

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Gainesville, Florida, United States

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Maitland, Florida, United States

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Ocala, Florida, United States

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Oldsmar, Florida, United States

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Ormond Beach, Florida, United States

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Palm Coast, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Suwanee, Georgia, United States

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Anderson, Indiana, United States

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Indianapolis, Indiana, United States

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Wellesley, Massachusetts, United States

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Detroit, Michigan, United States

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Golden Valley, Minnesota, United States

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Billings, Montana, United States

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Great Falls, Montana, United States

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Albuquerque, New Mexico, United States

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Charlotte, North Carolina, United States

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Akron, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Westerville, Ohio, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Greer, South Carolina, United States

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Cordova, Tennessee, United States

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Knoxville, Tennessee, United States

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Lubbock, Texas, United States

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Waukesha, Wisconsin, United States

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CABA, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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San Miguel de Tucumán, , Argentina

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Liverpool, New South Wales, Australia

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Vienna, , Austria

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Edegem, Antwerpen, Belgium

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Aalst, , Belgium

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Ghent, , Belgium

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Sofia, , Bulgaria

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London, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Osijek, , Croatia

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Zagreb, , Croatia

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Brno, Czech Republic, Czechia

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Havířov, Czech Republic, Czechia

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Tampere, , Finland

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Turku, , Finland

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Nice, Cedex1, France

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Drammen, , Norway

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Lima Cercado, Lima region, Peru

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San Isidro, Lima region, Peru

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Lima, , Peru

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Matosinhos Municipality, Porto District, Portugal

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Coimbra, , Portugal

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Kazan', , Russia

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Martin, , Slovakia

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Pretoria, , South Africa

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Rosebank, , South Africa

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Pozuelo de Alarcón, Madrid, Spain

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Barakaldo, Vizcaya, Spain

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Lugano, , Switzerland

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Tainan City, , Taiwan

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Haseki / Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Trabzon, , Turkey (Türkiye)

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Luton, Beds, United Kingdom

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Sheffield, South Yorkshire, United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Bulgaria Canada Croatia Czechia Finland France Germany Hungary India Italy Latvia Lithuania Mexico Norway Peru Poland Portugal Russia Slovakia South Africa Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

References

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Williams MJ, Amezcua L, Cohan SL, Cohen JA, Delgado SR, Hua LH, Lucassen EB, Piccolo RS, Koulouris CR, Stankiewicz J. Efficacy of Ofatumumab and Teriflunomide in Patients With Relapsing MS From Racial/Ethnic Minority Groups: ASCLEPIOS I/II Subgroup Analyses. Neurology. 2024 Aug 13;103(3):e209610. doi: 10.1212/WNL.0000000000209610. Epub 2024 Jul 17.

Reference Type DERIVED
PMID: 39018512 (View on PubMed)

Bhan V, Clift F, Baharnoori M, Thomas K, Patel BP, Blanchette F, Adlard N, Vudumula U, Gudala K, Dutta N, Grima D, Mouallif S, Farhane F. Cost-consequence analysis of ofatumumab for the treatment of relapsing-remitting multiple sclerosis in Canada. J Comp Eff Res. 2023 Sep;12(9):e220175. doi: 10.57264/cer-2022-0175. Epub 2023 Aug 22.

Reference Type DERIVED
PMID: 37606897 (View on PubMed)

Gartner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH, Deiva K, Ganjgahi H, Haring DA, Li B, Pingili R, Ramanathan K, Su W, Willi R, Kieseier B, Kappos L. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 Sep;28(10):1562-1575. doi: 10.1177/13524585221078825. Epub 2022 Mar 10.

Reference Type DERIVED
PMID: 35266417 (View on PubMed)

Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Haring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246.

Reference Type DERIVED
PMID: 32757523 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-005419-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

COMB157G2302

Identifier Type: -

Identifier Source: org_study_id