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

Primary Purpose

Relapsing Multiple Scelrosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ofatumumab subcutaneous injection

Teriflunomide-matching placebo capsules

Teriflunomide capsule

Matching placebo of ofatumumab subcutaneous injections

About this trial

This is an interventional treatment trial for Relapsing Multiple Scelrosis focused on measuring Relapsing multiple sclerosis, Ofatumumab, adult, OMB157, multiple sclerosis, T1 lesions, T2 lesions, relapse, GD-enhancing MRI, McDonald criteria, RRMS, SPMS

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OMG 20 mg

TER 14 mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

Annualized Relapse Rate (ARR)

ARR was the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). Comparisons were made to the previous rating (the last EDSS rating that did not occur during a relapse).

Secondary Outcome Measures

3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data

A 3-month confirmed disability worsening (3mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 3 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of ≥1.5, for patients with a baseline EDSS of 1 to 5 or ≥5.5, the criterion for disability worsening was an increase in EDSS of ≥1 or ≥0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.

3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302

6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data

A 6-month confirmed disability worsening (6mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of ≥1.5, for patients with a baseline EDSS of 1 to 5 or ≥5.5, the criterion for disability worsening was an increase in EDSS of ≥1 or ≥0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.

6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2302

6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data

A 6-month confirmed disability improvement (6mCDI) was defined as a decrease from baseline EDSS sustained for at least 6 months. For patients with a baseline EDSS of 0 to 1.5, no disability improvement was possible based on the protocol definition of an improvement; for patients with a baseline EDSS of ≥2 to 6 or ≥6.5 to 9.5, the criterion for disability improvement was a decrease in EDSS of ≤1 or ≤0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.

6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2302

Number of Gadolinium-enhancing T1 Lesions Per MRI Scan

Total number of Gd-enhancing T1 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)

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

The NfL concentration (geometric mean concentration) was estimated by treatment and time point with using a repeated measures model on the basis of all evaluable log-transformed NfL values.

Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline

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

Participants With Confirmed Relapse

A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system).

Annualized Relapse Rate (ARR) >8 Weeks After Onset of Treatment

3-month Confirmed Disability Worsening (3mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data

6-month Confirmed Disability Worsening (6mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data

6-month Confirmed Cognitive Decline on Symbol Digit Modalities Test (SDMT) - Pooled Data

A 6-month confirmed cognitive decline was defined as a decrease from baseline of at least 4 points in SDMT score sustained for at least 6 months. Processing speed was measured by the Symbol Digit Modalities Test (SDMT) score. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint

6-month Confirmed Disability Worsening (6mCDW) or 6-month Confirmed Cognitive Decline (6mCCD) - Pooled Data

A 6-month confirmed disability worsening (6mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of ≥1.5, for patients with a baseline EDSS of 1 to 5 or ≥5.5, the criterion for disability worsening was an increase in EDSS of ≥1 or ≥0.5, respectively. A 6-month confirmed cognitive decline (6mCCD) was defined as a 4-point worsening on Symbol Digit Modalities Test (SDMT) sustained for at least 6 months. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.

Change in Cognitive Performance Measured by the Symbol Digit Modalities Test (SDMT) - Pooled Data

Processing speed is being measured by the Symbol Digit Modalities Test (SDMT) score. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.

6-month Confirmed Worsening of at Least 20% in the Timed 25-Foot Walk (T25FW) - Pooled Data

The patient is directed to walk 25 feet quickly and safely as possible from one marked end to the other. The time is calculated from the initiation of the patient instructed to begin, until the patient has reached the 25-foot mark. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.

6-month Confirmed Worsening of at Least 20% in the 9-Hole Peg Test (9HPT) - Pooled Data

9-Hole Peg Test is a test of upper limb function. Participants place 9 pegs on pegboard and remove pegs and this is timed for each hand. Time recorded in seconds. Longer time indicates poorer upper limb function. 20% improvement is defined as 20% shorter time in seconds. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.

6-month Confirmed Disability Improvement (6mCDI) Sustained Until End of Study (EOS) as Measured by EDSS - Pooled Data

A 6-month confirmed disability improvement (6mCDI) sustained until EOS was defined as a decrease from baseline EDSS sustained until EOS. For patients with a baseline EDSS of 0 to 1.5, no disability improvement was possible based on the protocol definition of an improvement; for patients with a baseline EDSS of ≥2 to 6 or ≥6.5 to 9.5, the criterion for disability improvement was a decrease in EDSS of ≤1 or ≤0.5, respectively. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.

Number of New or Enlarging T2 Lesions on MRI Per Year From Month 12 Until End of Study (EOS)

Number of new/enlarging T2 lesions on the last available MRI scan compared to Month 12 adjusted for different time of scans versus Month 12 due to variable follow up time in study.

Percent Change in T2 Lesion Volume Relative to Baseline

Percent change from baseline in total T2 lesion volume

No Evidence of Disease Activity (NEDA-4)

NEDA-4 was defined as no 3-month confirmed disability worsening, no confirmed MS relapse, no new or enlarging T2 lesions compared to baseline, and the annualized rate of brain atrophy >-0.04%.

Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score Change From Baseline

MSIS-29 is a 29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life.

Multiple Sclerosis Impact Scale (MSIS-29) Psychological Impact Score Change From Baseline

Annualized Relapse Rates (ARR) by NfL High-low Subgroups - Pooled Data

Number of New or Enlarging T2 Lesions Per Year by NfL High-low Subgroups - Pooled Data

Number of new or enlarging T2 lesions on MRI per year (annualized lesion rate).

Brain Volume Loss by NfL High-low Subgroups - Pooled Data

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.

Pharmacokinetic (PK) Concentrations of Ofatumumab

Summary statistics of pharmacokinetic (PK) concentrations from trough samples collected within a 7-day window prior or at day of dosing.

Full Information

NCT ID

NCT02792231

First Posted

June 2, 2016

Last Updated

October 21, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02792231

Brief Title

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

Acronym

ASCLEPIOS II

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

August 26, 2016 (Actual)

Primary Completion Date

July 10, 2019 (Actual)

Study Completion Date

October 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

Detailed Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Multiple Scelrosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

955 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OMG 20 mg

Arm Type

Experimental

Arm Description

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

Arm Title

TER 14 mg

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ofatumumab subcutaneous injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Teriflunomide-matching placebo capsules

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Teriflunomide capsule

Intervention Description

Teriflunomide 14 mg oral capsule taken once daily

Intervention Type

Drug

Intervention Name(s)

Matching placebo of ofatumumab subcutaneous injections

Intervention Description

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

Primary Outcome Measure Information:

Title

Annualized Relapse Rate (ARR)

Description

Time Frame

Baseline up to 2.5 years

Secondary Outcome Measure Information:

Title

3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data

Description

Time Frame

Baseline, every 3 months up to 2.5 years

Title

3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302

Description

Time Frame

Baseline, every 3 months up to 2.5 years

Title

6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data

Description

Time Frame

Baseline, every 3 months up to 2.5 years

Title

6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2302

Description

Time Frame

Baseline, every 3 months up to 2.5 years

Title

6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data

Description

Time Frame

Baseline, every 3 months up to 2.5 years

Title

6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2302

Description

Time Frame

Baseline, every 3 months up to 2.5 years

Title

Number of Gadolinium-enhancing T1 Lesions Per MRI Scan

Description

Total number of Gd-enhancing T1 lesions across all scans per patient adjusted for different number of scans due to variable follow-up time in study.

Time Frame

Baseline, yearly up to 2.5 years

Title

Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate)

Description

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

Time Frame

Baseline, yearly up to 2.5 years

Title

Neurofilament Light Chain (NfL) Concentration in Serum

Description

The NfL concentration (geometric mean concentration) was estimated by treatment and time point with using a repeated measures model on the basis of all evaluable log-transformed NfL values.

Time Frame

Month 3, 12 and 24

Title

Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline

Description

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

Time Frame

Baseline, Months 12 and 24

Title

Participants With Confirmed Relapse

Description

Time Frame

Baseline up to 2.5 years

Title

Annualized Relapse Rate (ARR) >8 Weeks After Onset of Treatment

Description

Time Frame

Baseline up to 2.5 years

Title

3-month Confirmed Disability Worsening (3mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data

Description

Time Frame

Baseline up to 2.5 years

Title

6-month Confirmed Disability Worsening (6mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data

Description

Time Frame

Baseline up to 2.5 years

Title

6-month Confirmed Cognitive Decline on Symbol Digit Modalities Test (SDMT) - Pooled Data

Description

Time Frame

Baseline, every 6 months up to 2.5 years

Title

6-month Confirmed Disability Worsening (6mCDW) or 6-month Confirmed Cognitive Decline (6mCCD) - Pooled Data

Description

A 6-month confirmed disability worsening (6mCDW) was defined as an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months. For patients with a baseline EDSS of 0, the criterion for disability worsening was an increase in EDSS of ≥1.5, for patients with a baseline EDSS of 1 to 5 or ≥5.5, the criterion for disability worsening was an increase in EDSS of ≥1 or ≥0.5, respectively. A 6-month confirmed cognitive decline (6mCCD) was defined as a 4-point worsening on Symbol Digit Modalities Test (SDMT) sustained for at least 6 months. This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.

Time Frame

Baseline up to 2.5 years

Title

Change in Cognitive Performance Measured by the Symbol Digit Modalities Test (SDMT) - Pooled Data

Description

Time Frame

Baseline up to 2.5 years

Title

6-month Confirmed Worsening of at Least 20% in the Timed 25-Foot Walk (T25FW) - Pooled Data

Description

Time Frame

Baseline, every 3 months up to 2.5 years

Title

6-month Confirmed Worsening of at Least 20% in the 9-Hole Peg Test (9HPT) - Pooled Data

Description

Time Frame

Baseline, every 6 months up to 2.5 years

Title

6-month Confirmed Disability Improvement (6mCDI) Sustained Until End of Study (EOS) as Measured by EDSS - Pooled Data

Description

Time Frame

Baseline, every 3 months up to 2.5 years

Title

Number of New or Enlarging T2 Lesions on MRI Per Year From Month 12 Until End of Study (EOS)

Description

Number of new/enlarging T2 lesions on the last available MRI scan compared to Month 12 adjusted for different time of scans versus Month 12 due to variable follow up time in study.

Time Frame

Month 12 up to 2.5 years

Title

Percent Change in T2 Lesion Volume Relative to Baseline

Description

Percent change from baseline in total T2 lesion volume

Time Frame

Baseline, Month 12, Month 24

Title

No Evidence of Disease Activity (NEDA-4)

Description

NEDA-4 was defined as no 3-month confirmed disability worsening, no confirmed MS relapse, no new or enlarging T2 lesions compared to baseline, and the annualized rate of brain atrophy >-0.04%.

Time Frame

Baseline, Month 12, Month 24

Title

Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score Change From Baseline

Description

Time Frame

Baseline, every 6 months up to 2.5 years

Title

Multiple Sclerosis Impact Scale (MSIS-29) Psychological Impact Score Change From Baseline

Description

Time Frame

Baseline, every 6 months up to 2.5 years

Title

Annualized Relapse Rates (ARR) by NfL High-low Subgroups - Pooled Data

Description

Time Frame

Baseline up to 2.5 years

Title

Number of New or Enlarging T2 Lesions Per Year by NfL High-low Subgroups - Pooled Data

Description

Number of new or enlarging T2 lesions on MRI per year (annualized lesion rate).

Time Frame

Baseline, yearly up to 2.5 years

Title

Brain Volume Loss by NfL High-low Subgroups - Pooled Data

Description

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.

Time Frame

Baseline, Months 12 and 24

Title

Pharmacokinetic (PK) Concentrations of Ofatumumab

Description

Summary statistics of pharmacokinetic (PK) concentrations from trough samples collected within a 7-day window prior or at day of dosing.

Time Frame

Baseline, Weeks 4, 12, 24, 48, 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233-0271

Country

United States

Facility Name

Novartis Investigative Site

City

Cullman

State/Province

Alabama

ZIP/Postal Code

35058

Country

United States

Facility Name

Novartis Investigative Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novartis Investigative Site

City

Basalt

State/Province

Colorado

ZIP/Postal Code

81621

Country

United States

Facility Name

Novartis Investigative Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

Facility Name

Novartis Investigative Site

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Novartis Investigative Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

907-280528

Country

United States

Facility Name

Novartis Investigative Site

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Novartis Investigative Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

Novartis Investigative Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Facility Name

Novartis Investigative Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Novartis Investigative Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Novartis Investigative Site

City

Oldsmar

State/Province

Florida

ZIP/Postal Code

34677

Country

United States

Facility Name

Novartis Investigative Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Novartis Investigative Site

City

Palm Coast

State/Province

Florida

ZIP/Postal Code

32164

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

Novartis Investigative Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34243

Country

United States

Facility Name

Novartis Investigative Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32312

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Novartis Investigative Site

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

Novartis Investigative Site

City

Anderson

State/Province

Indiana

ZIP/Postal Code

46011

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Novartis Investigative Site

City

Wellesley

State/Province

Massachusetts

ZIP/Postal Code

02481

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Novartis Investigative Site

City

Golden Valley

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Novartis Investigative Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

Novartis Investigative Site

City

Great Falls

State/Province

Montana

ZIP/Postal Code

59405

Country

United States

Facility Name

Novartis Investigative Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131-0001

Country

United States

Facility Name

Novartis Investigative Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28202

Country

United States

Facility Name

Novartis Investigative Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Facility Name

Novartis Investigative Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

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Ohio

ZIP/Postal Code

43221

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United States

Facility Name

Novartis Investigative Site

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Westerville

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Ohio

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43081

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United States

Facility Name

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Oregon

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97225

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United States

Facility Name

Novartis Investigative Site

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Pittsburgh

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Pennsylvania

ZIP/Postal Code

15212

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United States

Facility Name

Novartis Investigative Site

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Willow Grove

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Pennsylvania

ZIP/Postal Code

19090

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United States

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Novartis Investigative Site

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Greer

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South Carolina

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29650

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United States

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Cordova

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Tennessee

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38018

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United States

Facility Name

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Knoxville

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Tennessee

ZIP/Postal Code

37922

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United States

Facility Name

Novartis Investigative Site

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Nashville

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Tennessee

ZIP/Postal Code

37205

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United States

Facility Name

Novartis Investigative Site

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Greenville

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Texas

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75401

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United States

Facility Name

Novartis Investigative Site

City

Lubbock

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Texas

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79410

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United States

Facility Name

Novartis Investigative Site

City

Sherman

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Texas

ZIP/Postal Code

75092

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United States

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Orem

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Utah

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84058

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United States

Facility Name

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Salt Lake City

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Utah

ZIP/Postal Code

84103

Country

United States

Facility Name

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City

Salt Lake City

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Utah

ZIP/Postal Code

84132

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United States

Facility Name

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Kirkland

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Washington

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98034

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United States

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Seattle

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Washington

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98122

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United States

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Tacoma

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Washington

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98405

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United States

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Waukesha

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Wisconsin

ZIP/Postal Code

53188

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United States

Facility Name

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Caba

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Buenos Aires

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C1428AQK

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Argentina

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Rosario

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Santa Fe

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S2000DSW

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Argentina

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Tucuman

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4000

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Argentina

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Liverpool

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New South Wales

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2170

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Australia

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Vienna

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1090

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Austria

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Wien

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1010

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Austria

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Edegem

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Antwerpen

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2650

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Belgium

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City

Aalst

ZIP/Postal Code

9300

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Belgium

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Bruxelles

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1200

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Belgium

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Gent

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9000

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Belgium

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City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1413

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

Novartis Investigative Site

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Novartis Investigative Site

City

Havirov

State/Province

Czech Republic

ZIP/Postal Code

736 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

Czech Republic

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava-Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Novartis Investigative Site

City

Nice

State/Province

Cedex1

ZIP/Postal Code

06001

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Novartis Investigative Site

City

Clermont-Ferrand

ZIP/Postal Code

63000

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Novartis Investigative Site

City

Rennes Cedex

ZIP/Postal Code

35033

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

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City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

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City

Hamburg

ZIP/Postal Code

22179

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

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City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

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City

Koln

ZIP/Postal Code

50935

Country

Germany

Facility Name

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City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04107

Country

Germany

Facility Name

Novartis Investigative Site

City

Minden

ZIP/Postal Code

32429

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1204

Country

Hungary

Facility Name

Novartis Investigative Site

City

Esztergom

State/Province

HUN

ZIP/Postal Code

2500

Country

Hungary

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500018

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 060

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400008

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400012

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

Novartis Investigative Site

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141008

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

ZIP/Postal Code

400016

Country

India

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

Novartis Investigative Site

City

Rome

ZIP/Postal Code

00178

Country

Italy

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

LV-1005

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Chihuahua

ZIP/Postal Code

31238

Country

Mexico

Facility Name

Novartis Investigative Site

City

Drammen

ZIP/Postal Code

1086

Country

Norway

Facility Name

Novartis Investigative Site

City

Cercado De Lima

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Lima

ZIP/Postal Code

LIMA 13

Country

Peru

Facility Name

Novartis Investigative Site

City

Glogow

ZIP/Postal Code

36-060

Country

Poland

Facility Name

Novartis Investigative Site

City

Rzeszow

ZIP/Postal Code

35 055

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 957

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Novartis Investigative Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Novartis Investigative Site

City

Matosinhos

State/Province

Porto

ZIP/Postal Code

4454509

Country

Portugal

Facility Name

Novartis Investigative Site

City

Amadora

ZIP/Postal Code

2720-276

Country

Portugal

Facility Name

Novartis Investigative Site

City

Braga

ZIP/Postal Code

4710243

Country

Portugal

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1169-050

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1500 650

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1600190

Country

Portugal

Facility Name

Novartis Investigative Site

City

Loures

ZIP/Postal Code

2674514

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4000001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Santa Maria da Feira

ZIP/Postal Code

4520 211

Country

Portugal

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Krasnoyarsk

ZIP/Postal Code

660049

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127015

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

ZIP/Postal Code

603137

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630087

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

813 69

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Ruzomberok

ZIP/Postal Code

03426

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0041

Country

South Africa

Facility Name

Novartis Investigative Site

City

Rosebank

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41017

Country

Spain

Facility Name

Novartis Investigative Site

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Novartis Investigative Site

City

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

ZIP/Postal Code

20014

Country

Spain

Facility Name

Novartis Investigative Site

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Haseki / Istanbul

ZIP/Postal Code

34096

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Facility Name

Novartis Investigative Site

City

Trabzon

ZIP/Postal Code

61080

Country

Turkey

Facility Name

Novartis Investigative Site

City

Luton

State/Province

Beds

ZIP/Postal Code

LU4 0DZ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Sheffield

State/Province

South Yorkshire

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

35266417

Citation

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.

Results Reference

derived

PubMed Identifier

32757523

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Relapsing Multiple Scelrosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial