Back to results

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

Primary Purpose

Relapsing Multiple Sclerosis

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 Sclerosis 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:

18 to 55 years of age
Diagnosis of multiple sclerosis (MS)
Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
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
Expanded disability status scale (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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OMB 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 COMB157G2302 to address this endpoint.

3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2301

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 COMB157G2302 to address this endpoint.

6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2301

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 COMB157G2302 to address this endpoint.

6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2301

Number of Gd-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

Percentage of 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 COMB157G2302 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 COMB157G2302 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.

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 COMB157G2302 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 COMB157G2302 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 COMB157G2302 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).

Annual Rate of Percent Change in 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

NCT02792218

First Posted

June 2, 2016

Last Updated

September 3, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02792218

Brief Title

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

Acronym

ASCLEPIOS I

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

September 2021

Overall Recruitment Status

Completed

Study Start Date

September 20, 2016 (Actual)

Primary Completion Date

July 5, 2019 (Actual)

Study Completion Date

July 20, 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 comparator-controlled, 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 Sclerosis

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

930 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OMB 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 pre-filled 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 COMB157G2301

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 COMB157G2301

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 COMB157G2301

Description

Time Frame

Baseline, every 3 months up to 2.5 years

Title

Number of Gd-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

Percentage of 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 COMB157G2302 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

Annual Rate of Percent Change in 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: 18 to 55 years of age Diagnosis of multiple sclerosis (MS) Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) 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 Expanded disability status scale (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

Facility Information:

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Novartis Investigative Site

City

Berkeley

State/Province

California

ZIP/Postal Code

94705

Country

United States

Facility Name

Novartis Investigative Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Novartis Investigative Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Novartis Investigative Site

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462-6608

Country

United States

Facility Name

Novartis Investigative Site

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Novartis Investigative Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Novartis Investigative Site

City

Loxahatchee Groves

State/Province

Florida

ZIP/Postal Code

33470

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33032

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Novartis Investigative Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Novartis Investigative Site

City

North Palm Beach

State/Province

Florida

ZIP/Postal Code

33408

Country

United States

Facility Name

Novartis Investigative Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32514

Country

United States

Facility Name

Novartis Investigative Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Novartis Investigative Site

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

Novartis Investigative Site

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Novartis Investigative Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Novartis Investigative Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Novartis Investigative Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Novartis Investigative Site

City

Northbrook

State/Province

Illinois

ZIP/Postal Code

60062

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Novartis Investigative Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314-2611

Country

United States

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Novartis Investigative Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Novartis Investigative Site

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Facility Name

Novartis Investigative Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70810

Country

United States

Facility Name

Novartis Investigative Site

City

Clinton Township

State/Province

Michigan

ZIP/Postal Code

48035

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

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

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Novartis Investigative Site

City

Ozark

State/Province

Missouri

ZIP/Postal Code

65721

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Novartis Investigative Site

City

Latham

State/Province

New York

ZIP/Postal Code

12110

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Novartis Investigative Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Novartis Investigative Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Novartis Investigative Site

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37604

Country

United States

Facility Name

Novartis Investigative Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Novartis Investigative Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79935

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Novartis Investigative Site

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Novartis Investigative Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23456

Country

United States

Facility Name

Novartis Investigative Site

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54311

Country

United States

Facility Name

Novartis Investigative Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Novartis Investigative Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Novartis Investigative Site

City

Neenah

State/Province

Wisconsin

ZIP/Postal Code

54956

Country

United States

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000BZL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

1061

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5004CDT

Country

Argentina

Facility Name

Novartis Investigative Site

City

New Lambton Heights

State/Province

New South Wales

ZIP/Postal Code

2305

Country

Australia

Facility Name

Novartis Investigative Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Novartis Investigative Site

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pelt

ZIP/Postal Code

3900

Country

Belgium

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T 1Z3

Country

Canada

Facility Name

Novartis Investigative Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J9J 0A5

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Novartis Investigative Site

City

Rijeka

State/Province

HRV

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Praha 4 Krc

State/Province

Czech Republic

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hradec Kralove

State/Province

CZE

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

State/Province

CZE

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

JIhlava

ZIP/Postal Code

586 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Pardubice

ZIP/Postal Code

532 03

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novartis Investigative Site

City

Nancy

State/Province

Cedex

ZIP/Postal Code

54035

Country

France

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Nimes Cedex

ZIP/Postal Code

30029

Country

France

Facility Name

Novartis Investigative Site

City

Barsinghausen

ZIP/Postal Code

30890

Country

Germany

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

D 33647

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80377

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuburg an der Donau

ZIP/Postal Code

86633

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14471

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 25

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 28

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

GR 54636

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1135

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110017

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560054

Country

India

Facility Name

Novartis Investigative Site

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682 026

Country

India

Facility Name

Novartis Investigative Site

City

Chandigarh

State/Province

Punjab

ZIP/Postal Code

160012

Country

India

Facility Name

Novartis Investigative Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700068

Country

India

Facility Name

Novartis Investigative Site

City

Mangalore

ZIP/Postal Code

575018

Country

India

Facility Name

Novartis Investigative Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

310 9601

Country

Israel

Facility Name

Novartis Investigative Site

City

Sefad

ZIP/Postal Code

13100

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00189

Country

Italy

Facility Name

Novartis Investigative Site

City

Gallarate

State/Province

ZIP/Postal Code

21013

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Novartis Investigative Site

City

Sittard-Geleen

State/Province

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80 952

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-462

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40 571

Country

Poland

Facility Name

Novartis Investigative Site

City

Kielce

ZIP/Postal Code

25 726

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90 324

Country

Poland

Facility Name

Novartis Investigative Site

City

Guaynabo

ZIP/Postal Code

00968

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630007

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saransk

ZIP/Postal Code

430032

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sestroretsk

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Tyumen

ZIP/Postal Code

625000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Banska Bystrica

ZIP/Postal Code

97517

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

82606

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

83305

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nitra

ZIP/Postal Code

94901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trnava

ZIP/Postal Code

917 75

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Cadiz

State/Province

Andalucia

ZIP/Postal Code

11009

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08026

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

L Hospitalet De Llobregat

State/Province

Catalunya

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Salt

State/Province

Cataluña

ZIP/Postal Code

17190

Country

Spain

Facility Name

Novartis Investigative Site

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Goeteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

102 35

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Khon Kaen

State/Province

THA

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34147

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Novartis Investigative Site

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Novartis Investigative Site

City

Headington

State/Province

Oxfordshire

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

E1 1BB

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

We'll reach out to this number within 24 hrs

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

Relapsing Multiple Sclerosis

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