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An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab (ARTIOS)

Primary Purpose

Relapsing Multiple Sclerosis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ofatumumab

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring RMS, MS, multiple sclerosis, relapsing multiple sclerosis, OMB157, adult, secondary progressive MS, SPMS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of MS according to the 2017 Revised McDonald criteria
Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS)
Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive)
MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT
Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration
Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
Neurologically stable within one month prior to first study drug administration

Exclusion Criteria:

Subjects with primary progressive MS or SPMS without disease activity
Subjects meeting criteria for neuromyelitis optica
Disease duration of more than 10 years since diagnosis
Pregnant or nursing (lactating) women
Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication
Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome
Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)
Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML
Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice
Subjects with active hepatitis B and C disease, assessed locally
Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.)
Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ofatumumab

Arm Description

Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days

Outcomes

Primary Outcome Measures

Annual Relapse Rate (ARR)

ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient

Secondary Outcome Measures

Safety evaluation

Proportion of patients with adverse events, including injection related reactions, abnormal laboratory results or vital signs, as well as proportion of patients discontinuing treatment due to insufficient effectiveness or tolerability/safety reasons

Full Information

NCT ID

NCT04353492

First Posted

April 16, 2020

Last Updated

September 29, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04353492

Brief Title

An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

Acronym

ARTIOS

Official Title

A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 14, 2020 (Actual)

Primary Completion Date

April 11, 2025 (Anticipated)

Study Completion Date

April 11, 2025 (Anticipated)

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

5. Study Description

Brief Summary

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Detailed Description

This is a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.

6. Conditions and Keywords

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

Relapsing Multiple Sclerosis

Keywords

RMS, MS, multiple sclerosis, relapsing multiple sclerosis, OMB157, adult, secondary progressive MS, SPMS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

564 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ofatumumab

Arm Type

Experimental

Arm Description

Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days

Intervention Type

Biological

Intervention Name(s)

Ofatumumab

Other Intervention Name(s)

OMB157

Intervention Description

Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)

Primary Outcome Measure Information:

Title

Annual Relapse Rate (ARR)

Description

ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient

Time Frame

Up to 96 weeks from baseline

Secondary Outcome Measure Information:

Title

Safety evaluation

Description

Time Frame

96 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of MS according to the 2017 Revised McDonald criteria Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS) Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive) MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions) Neurologically stable within one month prior to first study drug administration Exclusion Criteria: Subjects with primary progressive MS or SPMS without disease activity Subjects meeting criteria for neuromyelitis optica Disease duration of more than 10 years since diagnosis Pregnant or nursing (lactating) women Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS) Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice Subjects with active hepatitis B and C disease, assessed locally Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.) Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator

Facility Information:

Facility Name

Novartis Investigative Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

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

Newark

State/Province

Delaware

ZIP/Postal Code

19713

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

Maitland

State/Province

Florida

ZIP/Postal Code

32751

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

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

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

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

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

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

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

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131-0001

Country

United States

Facility Name

Novartis Investigative Site

City

Woodmere

State/Province

New York

ZIP/Postal Code

11598

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

Westerville

State/Province

Ohio

ZIP/Postal Code

43082

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

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107-5098

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

Novartis Investigative Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22030

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

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000BZL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSW

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1424BYD

Country

Argentina

Facility Name

Novartis Investigative Site

City

Tucuman

ZIP/Postal Code

4000

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

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Novartis Investigative Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Novartis Investigative Site

City

Linz

State/Province

Oberoesterreich

ZIP/Postal Code

A 4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1010

Country

Austria

Facility Name

Novartis Investigative Site

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

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

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

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

Hradec Kralove

State/Province

CZE

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

11315

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

D 33647

Country

Germany

Facility Name

Novartis Investigative Site

City

Cottbus

ZIP/Postal Code

03048

Country

Germany

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Novartis Investigative Site

City

Koln

ZIP/Postal Code

50935

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04275

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Osnabrück

ZIP/Postal Code

49076

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14471

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

89073

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Westerstede Oldenburg

ZIP/Postal Code

26655

Country

Germany

Facility Name

Novartis Investigative Site

City

Larissa

State/Province

ZIP/Postal Code

411 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Greece

ZIP/Postal Code

53246

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

State/Province

HUN

ZIP/Postal Code

1204

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

Komarom Esztergom

ZIP/Postal Code

1138

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00152

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37134

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

Ashrafieh

ZIP/Postal Code

166830

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Beirut

ZIP/Postal Code

10999

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Beirut

ZIP/Postal Code

1107 2020

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Beirut

ZIP/Postal Code

8610

Country

Lebanon

Facility Name

Novartis Investigative Site

City

Ciudad de Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Novartis Investigative Site

City

Morelia

State/Province

Michoacan

ZIP/Postal Code

58260

Country

Mexico

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

NO 0450

Country

Norway

Facility Name

Novartis Investigative Site

City

Bydgoszcz

State/Province

Woj Kujawsko-pomorskie

ZIP/Postal Code

85-796

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

90-153

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Novartis Investigative Site

City

Braga

ZIP/Postal Code

4710243

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1349-019

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

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115516

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127015

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

190000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Riyadh

State/Province

ZIP/Postal Code

11525

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Jeddah

ZIP/Postal Code

21499

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

04066

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

813 69

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

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08026

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

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

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Santa Cruz de Tenerife

ZIP/Postal Code

38009

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Sancaktepe

State/Province

Istanbul

ZIP/Postal Code

34785

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Novartis Investigative Site

City

Trabzon

ZIP/Postal Code

61080

Country

Turkey

Facility Name

Novartis Investigative Site

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Swansea

ZIP/Postal Code

SA12 7BR

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

Learn more about this trial

An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

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An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab (ARTIOS)

Relapsing Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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

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