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Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

Primary Purpose

Secondary Progressive Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

BAF312

Placebo

About this trial

This is an interventional treatment trial for Secondary Progressive Multiple Sclerosis focused on measuring Secondary Progressive Multiple Sclerosis

Eligibility Criteria

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

Inclusion Criteria:

Prior history of relapsing remitting MS
SPMS defined as progressive increase of disability over at least 6 months
EDSS score of 3.0 to 6.5
No relapse of corticosteroid treatment within 3 months

Exclusion Criteria:

Women of child bearing potential must use reliable forms of contraception.
Diagnosis of Macular edema during screening period
Any medically unstable condition determined by investigator.
Unable to undergo MRI scans
Hypersensitivity to any study drugs or drugs of similar class Other protocol defined inclusion/exclusion may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Siponimod (BAF312)

Placebo

Arm Description

Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on the treatment epoch for 3 months. During the Core Part of the study, participants participated in a maximum of 3 epochs. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312.

Matching placebo to BAF312 was administered orally during the Core Part of the trial. Following the Core Part, eligible participants enter the Extension Part during which all receive open-label BAF312.

Outcomes

Primary Outcome Measures

Percentage of Participants With 3-month Confirmed Disibility Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)

The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS steps, ranging from 0 (normal) to 10 (death due to MS). Confirmed disability is defined as an increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.

Secondary Outcome Measures

Efficacy of BAF312 Relative to Placebo in Confirmed Worsening of 25 Foot Walk Test

Delay in time to 3 month confirmed worsening of at least 20% from baseline in the timed 25 foot walk test.

Efficacy of BAF312 Relative to Placebo in Reducing the Increase in T2 Lesion Volume

Efficacy is shown by the reduction of the increase in T1 lesion volume.

The Delay in Time to Confirmed Disability Progression as Measured by EDSS.

Confirmed disability is defined as increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.

Efficacy of BAF Relative to Placebo in Annualized Relapses Rate and Time to the First Relapse

Efficacy of BAF312 relative to placebo was measured by the effect on confirmed relapses rate, the time to the first relapse, and proportion of patient free from relapses.

Overall Response Rate on the MSWS-12.

The overall response of the effect of BAF312 compared to placebo patients on the patient reported outcome form MSWS-12.

Effect on Inflammatory Disease Activity and Burden of Disease as Measured by MRI

Effect of BAF312 relative to placebo on disease activity and burden of disease as measured by Gd-T1 lesion, new/enlarged T2 lesion, and brain atrophy on brain MRI scans.

Effect on 3-month Confirmed Disability Progression as Defined by EDSS in Predefined Sub-groups

effect on confirmed disability progression in pre-defined subgroups, including patients with or without superimposed relapses, rapidly evolving patients with 1.5 point or greater change in EDSS score in 2 years prior to enrollment into the study. Patients with score of 4 or more in MSSS and those who don't meet this criteria.

Full Information

NCT ID

NCT01665144

First Posted

August 3, 2012

Last Updated

October 13, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01665144

Brief Title

Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

Official Title

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

December 20, 2012 (Actual)

Primary Completion Date

April 29, 2016 (Actual)

Study Completion Date

March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

6. Conditions and Keywords

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

Secondary Progressive Multiple Sclerosis

Keywords

Secondary Progressive Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1651 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Siponimod (BAF312)

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

BAF312

Intervention Description

0.25, 0.5, 1, and 2 mg film-coated tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Film-coated tablets

Primary Outcome Measure Information:

Title

Percentage of Participants With 3-month Confirmed Disibility Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)

Description

Time Frame

Baseline, every 3 month up to the maximum of approximately 3 years

Secondary Outcome Measure Information:

Title

Efficacy of BAF312 Relative to Placebo in Confirmed Worsening of 25 Foot Walk Test

Description

Delay in time to 3 month confirmed worsening of at least 20% from baseline in the timed 25 foot walk test.

Time Frame

Baseline , every 3 months up to the maximum of approximately 3 years

Title

Efficacy of BAF312 Relative to Placebo in Reducing the Increase in T2 Lesion Volume

Description

Efficacy is shown by the reduction of the increase in T1 lesion volume.

Time Frame

Baseline, every year up to the maximum of approximately 3 years

Title

The Delay in Time to Confirmed Disability Progression as Measured by EDSS.

Description

Confirmed disability is defined as increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.

Time Frame

Baseline, every 6 months up to the maximum of approximately 3 years

Title

Efficacy of BAF Relative to Placebo in Annualized Relapses Rate and Time to the First Relapse

Description

Efficacy of BAF312 relative to placebo was measured by the effect on confirmed relapses rate, the time to the first relapse, and proportion of patient free from relapses.

Time Frame

Baseline every 3 months up to the maximum of approximately 3 years

Title

Overall Response Rate on the MSWS-12.

Description

The overall response of the effect of BAF312 compared to placebo patients on the patient reported outcome form MSWS-12.

Time Frame

Baseline, every 6 months up to the maximum of approximately 3 years

Title

Effect on Inflammatory Disease Activity and Burden of Disease as Measured by MRI

Description

Effect of BAF312 relative to placebo on disease activity and burden of disease as measured by Gd-T1 lesion, new/enlarged T2 lesion, and brain atrophy on brain MRI scans.

Time Frame

Baseline, every 12 month up to the maximum of approximately 3 years

Title

Effect on 3-month Confirmed Disability Progression as Defined by EDSS in Predefined Sub-groups

Description

Time Frame

Baseline, every 3 months up to the maximum of approximately 3 years

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: Prior history of relapsing remitting MS SPMS defined as progressive increase of disability over at least 6 months EDSS score of 3.0 to 6.5 No relapse of corticosteroid treatment within 3 months Exclusion Criteria: Women of child bearing potential must use reliable forms of contraception. Diagnosis of Macular edema during screening period Any medically unstable condition determined by investigator. Unable to undergo MRI scans Hypersensitivity to any study drugs or drugs of similar class Other protocol defined inclusion/exclusion may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

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

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Novartis Investigative Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

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

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

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Novartis Investigative Site

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

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

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

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

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

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

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

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

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

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Novartis Investigative Site

City

Flossmoor

State/Province

Illinois

ZIP/Postal Code

60422

Country

United States

Facility Name

Novartis Investigative Site

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66212

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

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

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

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Novartis Investigative Site

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55446

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63131

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

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Novartis Investigative Site

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

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

New York

State/Province

New York

ZIP/Postal Code

10017

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Novartis Investigative Site

City

Patchogue

State/Province

New York

ZIP/Postal Code

11772

Country

United States

Facility Name

Novartis Investigative Site

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

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

Dayton

State/Province

Ohio

ZIP/Postal Code

45408

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Oregon

ZIP/Postal Code

97477

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Novartis Investigative Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02905

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Novartis Investigative Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

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

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

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

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1428AQK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1424

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1424BYD

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5000FAL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Novartis Investigative Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Novartis Investigative Site

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Novartis Investigative Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Novartis Investigative Site

City

Klagenfurt

ZIP/Postal Code

9020

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

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Fraiture En Condroz

ZIP/Postal Code

4557

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pelt

ZIP/Postal Code

3900

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sijsele

ZIP/Postal Code

8340

Country

Belgium

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

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2G3

Country

Canada

Facility Name

Novartis Investigative Site

City

Burnaby

State/Province

British Columbia

ZIP/Postal Code

V5G 2X6

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 4K4

Country

Canada

Facility Name

Novartis Investigative Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

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

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

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

Beijing

State/Province

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

Novartis Investigative Site

City

Taiyuan

State/Province

Shanxi

ZIP/Postal Code

030001

Country

China

Facility Name

Novartis Investigative Site

City

XI An

State/Province

Shanxi

ZIP/Postal Code

710038

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100028

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Rep.

ZIP/Postal Code

625 00

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

JIhlava

ZIP/Postal Code

586 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 5

ZIP/Postal Code

150 00

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

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Novartis Investigative Site

City

Nancy

State/Province

Cedex

ZIP/Postal Code

54035

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Novartis Investigative Site

City

CAEN Cedex

ZIP/Postal Code

14033

Country

France

Facility Name

Novartis Investigative Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Marseille Cedex 05

ZIP/Postal Code

13885

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

Novartis Investigative Site

City

Paris 13

ZIP/Postal Code

75651

Country

France

Facility Name

Novartis Investigative Site

City

Rennes

ZIP/Postal Code

35043

Country

France

Facility Name

Novartis Investigative Site

City

St Herblain

ZIP/Postal Code

44800

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Novartis Investigative Site

City

Regensburg

State/Province

Bavaria

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Berg

ZIP/Postal Code

82335

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10713

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13347

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33647

Country

Germany

Facility Name

Novartis Investigative Site

City

Boblingen

ZIP/Postal Code

71032

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53111

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60313

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22083

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30171

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

Novartis Investigative Site

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

Novartis Investigative Site

City

Itzehoe

ZIP/Postal Code

25524

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34121

Country

Germany

Facility Name

Novartis Investigative Site

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

Muenchen

ZIP/Postal Code

80377

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuburg an der Donau

ZIP/Postal Code

86633

Country

Germany

Facility Name

Novartis Investigative Site

City

Oldenburg

ZIP/Postal Code

26122

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14471

Country

Germany

Facility Name

Novartis Investigative Site

City

Prien

ZIP/Postal Code

83209

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwendi

ZIP/Postal Code

88477

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Facility Name

Novartis Investigative Site

City

Stade

ZIP/Postal Code

21682

Country

Germany

Facility Name

Novartis Investigative Site

City

Stadtroda

ZIP/Postal Code

07646

Country

Germany

Facility Name

Novartis Investigative Site

City

Teupitz

ZIP/Postal Code

15755

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

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion Crete

ZIP/Postal Code

711 10

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

1145

Country

Hungary

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

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

ZIP/Postal Code

H-3300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

H 8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Dublin 9

State/Province

ZIP/Postal Code

D09

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin 4

ZIP/Postal Code

D04 T6F

Country

Ireland

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Cefalu

State/Province

ZIP/Postal Code

90015

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00152

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00179

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Toon-city

State/Province

Ehime

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

Novartis Investigative Site

City

Asahikawa-city

State/Province

Hokkaido

ZIP/Postal Code

070-8644

Country

Japan

Facility Name

Novartis Investigative Site

City

Morioka

State/Province

Iwate

ZIP/Postal Code

020-8505

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto-city

State/Province

Kyoto

ZIP/Postal Code

616-8147

Country

Japan

Facility Name

Novartis Investigative Site

City

Suita

State/Province

Osaka

ZIP/Postal Code

565 0871

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawagoe

State/Province

Saitama

ZIP/Postal Code

350 8550

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokorozawa city

State/Province

Saitama

ZIP/Postal Code

359 8513

Country

Japan

Facility Name

Novartis Investigative Site

City

Kodaira

State/Province

Tokyo

ZIP/Postal Code

187-8551

Country

Japan

Facility Name

Novartis Investigative Site

City

Ota-ku

State/Province

Tokyo

ZIP/Postal Code

145-0065

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku ku

State/Province

Tokyo

ZIP/Postal Code

162 8666

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160 8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Aomori

ZIP/Postal Code

030 8553

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiba

ZIP/Postal Code

260 8677

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

556-0016

Country

Japan

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

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Breda

State/Province

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hoorn

ZIP/Postal Code

1624 NP

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Grudziadz

ZIP/Postal Code

86 300

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

Konskie

ZIP/Postal Code

26 200

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-637

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90 324

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-957

Country

Poland

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

1600190

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Constanta

State/Province

Jud. Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

020125

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

050098

Country

Romania

Facility Name

Novartis Investigative Site

City

Suceava

ZIP/Postal Code

727525

Country

Romania

Facility Name

Novartis Investigative Site

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

ZIP/Postal Code

300736

Country

Romania

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420043

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127018

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

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

Ufa

ZIP/Postal Code

450000

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

813 69

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nitra

ZIP/Postal Code

94911

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

081 81

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trencin

ZIP/Postal Code

91171

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trnava

ZIP/Postal Code

917 75

Country

Slovakia

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

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08026

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

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

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

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

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48013

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

State/Province

Pais Vasco

ZIP/Postal Code

20080

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

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

Stockholm

ZIP/Postal Code

10235

Country

Sweden

Facility Name

Novartis Investigative Site

City

Aarau

State/Province

ZIP/Postal Code

5001

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Luzern

ZIP/Postal Code

6000

Country

Switzerland

Facility Name

Novartis Investigative Site

City

St Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Altunizade

ZIP/Postal Code

34662

Country

Turkey

Facility Name

Novartis Investigative Site

City

Haseki Istanbul

ZIP/Postal Code

34096

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Novartis Investigative Site

City

Mecidiyekoy Istanbul

ZIP/Postal Code

34394

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

Salford

State/Province

Manchester

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Headington

State/Province

Oxfordshire

ZIP/Postal Code

OX3 9DU

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

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

ZIP/Postal Code

LS1 3EX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE5 4PW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W8 6RF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

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 Locations: central Contact Info Novartis.email@novartis.com

Citations:

PubMed Identifier

35639197

Citation

Gold R, Piani-Meier D, Kappos L, Bar-Or A, Vermersch P, Giovannoni G, Fox RJ, Arnold DL, Benedict RHB, Penner IK, Rouyrre N, Kilaru A, Karlsson G, Ritter S, Dahlke F, Hach T, Cree BAC. Siponimod vs placebo in active secondary progressive multiple sclerosis: a post hoc analysis from the phase 3 EXPAND study. J Neurol. 2022 Sep;269(9):5093-5104. doi: 10.1007/s00415-022-11166-z. Epub 2022 May 31.

Results Reference

derived

PubMed Identifier

35380078

Citation

Cree BA, Arnold DL, Fox RJ, Gold R, Vermersch P, Benedict RH, Bar-Or A, Piani-Meier D, Rouyrre N, Ritter S, Kilaru A, Karlsson G, Giovannoni G, Kappos L. Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years. Mult Scler. 2022 Sep;28(10):1591-1605. doi: 10.1177/13524585221083194. Epub 2022 Apr 5.

Results Reference

derived

PubMed Identifier

35379762

Citation

Leppert D, Kropshofer H, Haring DA, Dahlke F, Patil A, Meinert R, Tomic D, Kappos L, Kuhle J. Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials. Neurology. 2022 May 24;98(21):e2120-e2131. doi: 10.1212/WNL.0000000000200258. Epub 2022 Apr 4.

Results Reference

derived

PubMed Identifier

35261318

Citation

Arnold DL, Piani-Meier D, Bar-Or A, Benedict RH, Cree BA, Giovannoni G, Gold R, Vermersch P, Arnould S, Dahlke F, Hach T, Ritter S, Karlsson G, Kappos L, Fox RJ; EXPAND Clinical Investigators. Effect of siponimod on magnetic resonance imaging measures of neurodegeneration and myelination in secondary progressive multiple sclerosis: Gray matter atrophy and magnetization transfer ratio analyses from the EXPAND phase 3 trial. Mult Scler. 2022 Sep;28(10):1526-1540. doi: 10.1177/13524585221076717. Epub 2022 Mar 9.

Results Reference

derived

PubMed Identifier

33791945

Citation

Schur N, Gudala K, Vudumula U, Vadapalle S, Bhadhuri A, Casanova A, Adlard N, Schwenkglenks M. Cost Effectiveness and Budget Impact of Siponimod Compared to Interferon Beta-1a in the Treatment of Adult Patients with Secondary Progressive Multiple Sclerosis with Active Disease in Switzerland. Pharmacoeconomics. 2021 May;39(5):563-577. doi: 10.1007/s40273-021-01023-8. Epub 2021 Apr 1.

Results Reference

derived

PubMed Identifier

33328324

Citation

Benedict RHB, Tomic D, Cree BA, Fox R, Giovannoni G, Bar-Or A, Gold R, Vermersch P, Pohlmann H, Wright I, Karlsson G, Dahlke F, Wolf C, Kappos L. Siponimod and Cognition in Secondary Progressive Multiple Sclerosis: EXPAND Secondary Analyses. Neurology. 2021 Jan 19;96(3):e376-e386. doi: 10.1212/WNL.0000000000011275. Epub 2020 Dec 16.

Results Reference

derived

PubMed Identifier

29576505

Citation

Kappos L, Bar-Or A, Cree BAC, Fox RJ, Giovannoni G, Gold R, Vermersch P, Arnold DL, Arnould S, Scherz T, Wolf C, Wallstrom E, Dahlke F; EXPAND Clinical Investigators. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018 Mar 31;391(10127):1263-1273. doi: 10.1016/S0140-6736(18)30475-6. Epub 2018 Mar 23. Erratum In: Lancet. 2018 Nov 17;392(10160):2170.

Results Reference

derived

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Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

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Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

Secondary Progressive Multiple Sclerosis

About this trial

Eligibility Criteria

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Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

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1. Study Identification

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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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