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Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)

Primary Purpose

Relapsing Multiple Sclerosis

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ofatumumab

Tetanus toxoid (TT) containing vaccine (Td, Tdap)

13-valent pneumococcal conjugate vaccine (13-PCV)

23-valent pneumococcal polysaccharide vaccine (23-PPV)

Seasonal Quadrivalent influenza vaccine

Keyhole limpet hemocyanin (KLH) neo-antigen

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring ofatumumab, relapsing multiple sclerosis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
Written informed consent

Exclusion Criteria:

Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
Subjects taking medications prohibited by the protocol
Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Vaccination sub-study:

Inclusion criteria

Informed consent
Actively enrolled in the COMB157G2399 Study
12 weeks of continuous treatment within the COMB157G2399 Study
prior vaccination history as per protocol-defined

Exclusion criteria

known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
allergies to egg or shellfish
any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit

Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ofatumumab

Arm Description

Subcutaneous injection

Outcomes

Primary Outcome Measures

Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes

Secondary Outcome Measures

Number of relapse rates per year

Annual Relapse Rate (ARR) time calculated as number of confirmed relapses divided by time in study per year and will also be presented for the entire duration

Patients with confirmed 3 and 6 month disability worsening

A confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3, or 6 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).

Patients with confirmed 6, 12 and 24 month disability improvement and improvement until end of study

Confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6, 12 or 24 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).

Patients with changes in Expanded Disability Status Scale (EDSS) scores

Score changes in Expanded Disability Status Scale (EDSS) over time EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).

Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores

Score changes and confirmed 4-point worsening sustained for 6 months in Symbol Digit Modalities Test (SDMT) scores The Symbol Digit Modalities Test is a neuropsychological, timed test for sustained attention and concentration. 3 versions will be used, alternating at each visit where done. The number of correct responses will be counted for the score.

Changes in the Magnetic Resonance Image (MRI) related to brain volume loss

Percent change from baseline in brain volume loss (BVL)

Changes in the Magnetic Resonance Image (MRI) related to T2 lesions

Number of new or enlarging T2 lesions

Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions

Total number of Gd-enhancing lesions on all MRI scans adjusted for different time of scan versus follow up time in study

Changes in neurofilament light change serum concentration

Extent of neurofilament light change concentration in blood NfL is a component of the neuronal cytoskeleton and is released into the cerebrospinal fluid and into subsequently blood following neuro-axonal damage

Full Information

NCT ID

NCT03650114

First Posted

August 17, 2018

Last Updated

September 29, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03650114

Brief Title

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Acronym

ALITHIOS

Official Title

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 28, 2018 (Actual)

Primary Completion Date

December 30, 2027 (Anticipated)

Study Completion Date

September 7, 2028 (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

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

6. Conditions and Keywords

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

Relapsing Multiple Sclerosis

Keywords

ofatumumab, relapsing multiple sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2060 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ofatumumab

Arm Type

Experimental

Arm Description

Subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

Ofatumumab

Intervention Description

subcutaneous injection of 20 mg ofatumumab every 4 weeks

Intervention Type

Biological

Intervention Name(s)

Tetanus toxoid (TT) containing vaccine (Td, Tdap)

Intervention Description

0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid

Intervention Type

Biological

Intervention Name(s)

13-valent pneumococcal conjugate vaccine (13-PCV)

Intervention Description

0.5mL Vial/Syringe

Intervention Type

Biological

Intervention Name(s)

23-valent pneumococcal polysaccharide vaccine (23-PPV)

Intervention Description

0.5mL Vial/Syringe

Intervention Type

Biological

Intervention Name(s)

Seasonal Quadrivalent influenza vaccine

Intervention Description

Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)

Intervention Type

Biological

Intervention Name(s)

Keyhole limpet hemocyanin (KLH) neo-antigen

Intervention Description

1mg Vial

Primary Outcome Measure Information:

Title

Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes

Time Frame

Up to 5 years

Secondary Outcome Measure Information:

Title

Number of relapse rates per year

Description

Annual Relapse Rate (ARR) time calculated as number of confirmed relapses divided by time in study per year and will also be presented for the entire duration

Time Frame

Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)

Title

Patients with confirmed 3 and 6 month disability worsening

Description

Time Frame

Duration of the study, approximately 5 years

Title

Patients with confirmed 6, 12 and 24 month disability improvement and improvement until end of study

Description

Time Frame

Duration of the study, approximately 5 years

Title

Patients with changes in Expanded Disability Status Scale (EDSS) scores

Description

Time Frame

Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)

Title

Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores

Description

Time Frame

Duration of the study, approximately 5 years

Title

Changes in the Magnetic Resonance Image (MRI) related to brain volume loss

Description

Percent change from baseline in brain volume loss (BVL)

Time Frame

Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)

Title

Changes in the Magnetic Resonance Image (MRI) related to T2 lesions

Description

Number of new or enlarging T2 lesions

Time Frame

Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)

Title

Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions

Description

Total number of Gd-enhancing lesions on all MRI scans adjusted for different time of scan versus follow up time in study

Time Frame

Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)

Title

Changes in neurofilament light change serum concentration

Description

Time Frame

Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)

Other Pre-specified Outcome Measures:

Title

Hummoral immune response to TT vaccine

Description

Proportion of subjects with a positive antibody response to TT vaccine measured 4 and 8 weeks after vaccination while treated with ofatumumab 2-fold increase in titer level Tetanus anti-bodies ≥ 0.2 IU/mL Mean titers of anti-tetanus antibody

Time Frame

Pre-vaccination, 4 and 8 weeks post-vaccination

Title

Hummoral immune response to 13-valent pneumococcal conjugate vaccine (13-PCV)

Description

Proportion of subjects with a positive antibody response against individual anti-pneumococcal antibody serotypes while treated with ofatumumab 2-fold increase in titer level or a > 1 microgram/mL rise in titer compared with pre-immunization titer Positive anti-body response against at least 2 of the 13 pneumococcal antibody serotypes Positive anti-body response against at least 50% of serotypes Mean titers of anti-pneumococcal antibody

Time Frame

4 and 8 weeks

Title

Hummoral immune response to 13-PCV boosted eight weeks later by 23-valent pneumococcal polysaccharide vaccine (23-PPV)

Description

Proportion of subjects with a positive antibody response against individual anti-pneumococcal antibody serotypes (23 serotypes to be tested individually) measured 4 and 8 weeks after the booster 23-PPV while the subject continues to be treated with ofatumumab 2-fold increase in titer level or a > 1 microgram/mL rise in titer compared with pre-immunization titer Positive anti-body response against at least 2 of the 23 pneumococcal antibody serotypes Positive anti-body response against at least 50% of serotypes Mean titers of anti-pneumococcal antibody

Time Frame

Pre-vaccination, 4 and 8 weeks post-vaccination

Title

Humoral immune response to KLH neo-antigen

Description

Mean titers of anti-KLH antibody measured immediately prior the first administration of KLH and measured immediately prior to the first administration, 4, 8 and 12 weeks after the first administration, and measured 4 weeks post last administration of KLH

Time Frame

Pre-administration, 4, 8, 12 weeks after initial administration and 4 weeks after last administration

Title

Hummoral immune response to 2020-2021 seasonal quadrivalent influenza vaccine

Description

Proportion of subjects fulfilling: Seroconversion: The pre-vaccination HI antibody titer is < 1:10 and the postvaccination measurement is ≥ 1:40 (this applies to subjects with a pre-vaccination HI titer < 1:10), or Significant increase in HI antibody titer: The pre-vaccination HI antibody titer is ≥ 1:10 and the increase from the pre- to the post-vaccination measurement is ≥ 4-fold (this applies to subjects with a pre-vaccination HI titer ≥ 1:10)

Time Frame

Pre-vaccination and 4 weeks post-vaccination

Title

Antibody response rate to TT and influenza vaccination as a function of exposure to ofatumumab

Description

Immune response to TT and influenza vaccination

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks Written informed consent Exclusion Criteria: Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS) Subjects taking medications prohibited by the protocol Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply Vaccination sub-study: Inclusion criteria Informed consent Actively enrolled in the COMB157G2399 Study 12 weeks of continuous treatment within the COMB157G2399 Study prior vaccination history as per protocol-defined Exclusion criteria known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines allergies to egg or shellfish any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit Other protocol-defined inclusion/exclusion criteria may apply

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

1-888-669-6682

Novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233-0271

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Cullman

State/Province

Alabama

ZIP/Postal Code

35058

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Basalt

State/Province

Colorado

ZIP/Postal Code

81621

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462-6608

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33445

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33032

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Oldsmar

State/Province

Florida

ZIP/Postal Code

34677

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32514

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34233

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34243

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32312

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Northbrook

State/Province

Illinois

ZIP/Postal Code

60062

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314-2611

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160-7330

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70810

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Wellesley

State/Province

Massachusetts

ZIP/Postal Code

02481

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202 2689

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55446

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ozark

State/Province

Missouri

ZIP/Postal Code

65721

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Great Falls

State/Province

Montana

ZIP/Postal Code

59405

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131-0001

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Latham

State/Province

New York

ZIP/Postal Code

12110

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Westerville

State/Province

Ohio

ZIP/Postal Code

43082

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107-5098

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Individual Site Status

Terminated

Facility Name

Novartis Investigative Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Cordova

State/Province

Tennessee

ZIP/Postal Code

38018

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Johnson

State/Province

Tennessee

ZIP/Postal Code

37604

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37922

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79935

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novartis Investigative Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sherman

State/Province

Texas

ZIP/Postal Code

75092

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84103

Country

United States

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23456

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54311

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000BZL

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSW

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1424BYD

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5004CDT

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

New Lambton Heights

State/Province

New South Wales

ZIP/Postal Code

2305

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1010

Country

Austria

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1413

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J9J 0A5

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2J2

Country

Canada

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Rijeka

State/Province

HRV

ZIP/Postal Code

51000

Country

Croatia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

656 91

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Havirov

State/Province

Czech Republic

ZIP/Postal Code

736 01

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

Czech Republic

ZIP/Postal Code

415 01

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Hradec Kralove

State/Province

CZE

ZIP/Postal Code

500 05

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Olomouc

State/Province

CZE

ZIP/Postal Code

779 00

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

JIhlava

ZIP/Postal Code

586 01

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Ostrava Poruba

ZIP/Postal Code

708 52

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Pardubice

ZIP/Postal Code

532 03

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Praha 4

ZIP/Postal Code

140 59

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Nice

State/Province

Cedex1

ZIP/Postal Code

06001

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Nimes

ZIP/Postal Code

30029

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Paris 13

ZIP/Postal Code

75651

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barsinghausen

ZIP/Postal Code

30890

Country

Germany

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

D 33647

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22179

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Koln

ZIP/Postal Code

50935

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Minden

ZIP/Postal Code

32429

Country

Germany

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80377

Country

Germany

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Neuburg an der Donau

ZIP/Postal Code

86633

Country

Germany

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14471

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57076

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 25

Country

Greece

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

GR 54636

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1135

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1138

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Budapest

State/Province

HUN

ZIP/Postal Code

1204

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7623

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 060

Country

India

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110017

Country

India

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682 026

Country

India

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400008

Country

India

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Chandigarh

State/Province

Punjab

ZIP/Postal Code

160012

Country

India

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500082

Country

India

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Howrah

State/Province

West Bengal

ZIP/Postal Code

711103

Country

India

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Mangalore

ZIP/Postal Code

575018

Country

India

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Sefad

ZIP/Postal Code

13100

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Toon-city

State/Province

Ehime

ZIP/Postal Code

791-0295

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Sapporo city

State/Province

Hokkaido

ZIP/Postal Code

063-0005

Country

Japan

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Morioka

State/Province

Iwate

ZIP/Postal Code

020-8505

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Sendai city

State/Province

Miyagi

ZIP/Postal Code

980 8574

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Sendai city

State/Province

Miyagi

ZIP/Postal Code

983 8512

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Kawagoe

State/Province

Saitama

ZIP/Postal Code

350 8550

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Kodaira

State/Province

Tokyo

ZIP/Postal Code

187-8551

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160 8582

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Chiba

ZIP/Postal Code

260 8677

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Niigata

ZIP/Postal Code

951 8520

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

556-0016

Country

Japan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

LV-1005

Country

Latvia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1038

Country

Latvia

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Ciudad de Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Morelia

State/Province

Michoacan

ZIP/Postal Code

58260

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Chihuahua

ZIP/Postal Code

31238

Country

Mexico

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Drammen

ZIP/Postal Code

1086

Country

Norway

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Cercado De Lima

State/Province

Lima

ZIP/Postal Code

Country

Peru

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Lima

ZIP/Postal Code

Country

Peru

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Lima

ZIP/Postal Code

LIMA 13

Country

Peru

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Bydgoszcz

State/Province

Woj Kujawsko-pomorskie

ZIP/Postal Code

85-796

Country

Poland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80 952

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-462

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-803

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Glogow

ZIP/Postal Code

36-060

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40 571

Country

Poland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kielce

ZIP/Postal Code

25 726

Country

Poland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90 324

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Rzeszow

ZIP/Postal Code

35 055

Country

Poland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 957

Country

Poland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

51-685

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Matosinhos

State/Province

Porto

ZIP/Postal Code

4454509

Country

Portugal

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Braga

ZIP/Postal Code

4710243

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000 075

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1169-050

Country

Portugal

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1500 650

Country

Portugal

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Loures

ZIP/Postal Code

2674514

Country

Portugal

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Santa Maria da Feira

ZIP/Postal Code

4520 211

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420043

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Krasnoyarsk

ZIP/Postal Code

660049

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

127015

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

ZIP/Postal Code

603137

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630007

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630087

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Saransk

ZIP/Postal Code

430032

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sestroretsk

ZIP/Postal Code

197706

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

190000

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tyumen

ZIP/Postal Code

625000

Country

Russian Federation

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

813 69

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

82606

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

83305

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Nitra

ZIP/Postal Code

94901

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Trnava

ZIP/Postal Code

917 75

Country

Slovakia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0041

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Rosebank

ZIP/Postal Code

2196

Country

South Africa

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Cadiz

State/Province

Andalucia

ZIP/Postal Code

11009

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08026

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Salt

State/Province

Cataluna

ZIP/Postal Code

17190

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Pozuelo de Alarcon

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

San Sebastian

State/Province

Pais Vasco

ZIP/Postal Code

20080

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Castilleja De La Cuesta

State/Province

Sevilla

ZIP/Postal Code

41950

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Goeteborg

ZIP/Postal Code

413 45

Country

Sweden

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

102 35

Country

Sweden

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Khon Kaen

State/Province

THA

ZIP/Postal Code

40002

Country

Thailand

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Sancaktepe

State/Province

Istanbul

ZIP/Postal Code

34785

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Haseki Istanbul

ZIP/Postal Code

34096

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34147

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Individual Site Status

Completed

Facility Name

Novartis Investigative Site

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Trabzon

ZIP/Postal Code

61080

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Luton

State/Province

Beds

ZIP/Postal Code

LU4 0DZ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Headington

State/Province

Oxfordshire

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sheffield

State/Province

South Yorkshire

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Individual Site Status

Recruiting

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

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Learn more about this trial

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

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Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)

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

Learn more about this trial