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This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. (INFORMS)

Primary Purpose

Primary Progressive Multiple Sclerosis

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

FTY720

Placebo

About this trial

This is an interventional treatment trial for Primary Progressive Multiple Sclerosis focused on measuring FTY720, primary progressive multiple sclerosis,PPMS

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

General

sign written informed consent prior to participating in the study
25 through 65 years of age inclusive
females of childbearing potential must:
- have a negative pregnancy test at Baseline (prior to randomization) and
- use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication

Primary Progressive Multiple sclerosis.

diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria):
time since first reported symptoms between 2 and 10 years
evidence of clinical disability progression in the 2 years prior to Screening
disability status at Screening
- EDSS score of 3.5-6.0 inclusive
- pyramidal functional system score of 2 or more
- 25'TWT less than 30 seconds

Extension study Inclusion criteria

Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, were to have completed at least 3 years on study drug treatment at the time of extension study initiation.
Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort, were to have continued on study drug treatment until such time as the last ongoing patient enrolled in the study had reached 3 years in study

Exclusion Criteria:

PPMS specific:

History of relapses/attacks
Progressive neurological disorder other than PPMS
Pure cerebellar syndrome or pure visual progressive syndrome or pure
cognitive progressive syndrome
Presence of spinal cord compression at screening MRI
Relevant history of vitamin B12 deficit
Evidence of syphilis or borreliosis at Screening

Cardiovascular conditions:

Myocardial infarction within the past 6 months or current unstable ischemic heart disease
History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon
Severe cardiac failure or cardiac arrest
History of symptomatic bradycardia
Resting pulse <55 bpm pre-dose
History of sick sinus syndrome or sino-atrial heart block
History or presence of second and third degree AV block or an increase QT interval (QTc>440 ms)
Arrythmia requiring treatment with class III antiarrythmic drugs
History of positive tilt test from workout of vasovagal syncope
Hypertension, not controlled with medication

Pulmonary:

Severe respiratory disease or pulmonary fibrosis
TB
Abnormal X-ray, suggestive of active pulmonary disease
Abnormal PFT: <70% of predicted for FEV1 and FVC; <60% for DLCO
Patients receiving chronic (daily) therapies for asthma

Hepatic:

Known history of alcohol abuse, chronic liver or biliary disease
Total or conjugated Brb >ULN, unless in context of Gilbert's syndrome
AP >1.5xULN; ALT/AST >2xULN; GGT>3xULN

Other:

History of chronic disease of the immune system other than MS
Malignancy (other than successfully treated SCC or BCC)
Diabetes Mellitus
Macular Edema present at screening
HIV, Hepatitis C or B, other active infection
History of total lymphoid irradiation or bone marrow transplantation
Serum creatinine >1.7 mg/dl
WBC <3500 cells/mm3
Lymphocyte count <800 cells/mm3
History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures
Unable to undergo MRI scans
Participation in any therapeutical clinical research study in the 6 months prior to randomization
Pregnant or lactating women
Drugs requiring wash-out period:
3 months:
- Systemic corticosteroids or ACTH
- INF-beta
  6 months:
- Immunosuppressive medication
- Immunoglobulins
- Monoclonal antibodies
Drugs that exclude participation in the study:
Cladribine
Cyclophosphamide
Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study)

Extension study Exclusion criteria

-Patients were not eligible for enrollment in the extension study if they had any of the following key exclusion criteria at the extension study Baseline visit: active chronic immune system disease other than MS (or stable disease treated with immune therapy); known immunodeficiency syndrome; active infection; uncontrolled diabetes mellitus; macularedema; treatment with Class Ia or III antiarrhythmic drugs; any of the specified cardiac, pulmonary, or hepatic conditions; or any medically unstable condition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

FTY720D 0.5 mg

Placebo

FTY720D 1.25 mg switch to 0.5 mg

Arm Description

Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment

Cohort 1 and 2: Patients randomized to placebo continued on placebo after re-randomization

Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment on Nov 2009

Outcomes

Primary Outcome Measures

Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint

3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25' TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.

Secondary Outcome Measures

Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)

The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and 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, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)

Percent Change From Baseline in Brain Volume at Month 36

The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.

Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.

The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis

Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.

The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis

Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36

Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis

Number of Gd-enhancing Lesions at Month 36

Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis

Percent Change in Total T2 Lesion Volume From Baseline to Month 36

Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis

Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)

The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score

Change From Baseline in PRIMUS-Activities

The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).

Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score

Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).

Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D Score)

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)

The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42*100).

Blood Concentrations of Fingolimod and Fingolimod-phosphate

Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate. Venous blood samples were collected for the analysis.

Change in MSFC Z-score and Subscale Scores From Baseline to Month 36

The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.

Full Information

NCT ID

NCT00731692

First Posted

August 7, 2008

Last Updated

May 9, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00731692

Brief Title

This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.

Acronym

INFORMS

Official Title

A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

The extension study was terminated early after the results of the core study showed the study did not meet primary endpoint; confirmed disability progression

Study Start Date

July 28, 2008 (Actual)

Primary Completion Date

June 22, 2015 (Actual)

Study Completion Date

June 22, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population

6. Conditions and Keywords

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

Primary Progressive Multiple Sclerosis

Keywords

FTY720, primary progressive multiple sclerosis,PPMS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

970 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FTY720D 0.5 mg

Arm Type

Experimental

Arm Description

Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Cohort 1 and 2: Patients randomized to placebo continued on placebo after re-randomization

Arm Title

FTY720D 1.25 mg switch to 0.5 mg

Arm Type

Experimental

Arm Description

Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment on Nov 2009

Intervention Type

Drug

Intervention Name(s)

FTY720

Intervention Description

Fingolimod capsules at doses of 1.25 mg (prior to implementation of Amendment 5) and 0.5 mg (after Amendment 5) were administered orally once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo capsules were administered orally once daily

Primary Outcome Measure Information:

Title

Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint

Description

Time Frame

up to 36 months after the last patient was randomized

Secondary Outcome Measure Information:

Title

Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)

Description

Time Frame

up to 36 months after the last patient was randomized

Title

Percent Change From Baseline in Brain Volume at Month 36

Description

Time Frame

Baseline to month 36

Title

Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.

Description

The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis

Time Frame

up to 36 months after the last patient was randomized

Title

Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.

Description

The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis

Time Frame

up to 36 months after the last patient was randomized

Title

Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36

Description

Time Frame

Baseline to 36 months

Title

Number of Gd-enhancing Lesions at Month 36

Description

Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis

Time Frame

Baseline to 36 months

Title

Percent Change in Total T2 Lesion Volume From Baseline to Month 36

Description

Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis

Time Frame

Baseline to month 36

Title

Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)

Description

Time Frame

Baseline, 36 months

Title

Change From Baseline in PRIMUS-Activities

Description

Time Frame

Baseline, 36 months

Title

Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score

Description

Time Frame

Baseline, 36 months

Title

Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D Score)

Description

Time Frame

Baseline, 36 months

Title

Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)

Description

Time Frame

Baseline, 36 months

Title

Blood Concentrations of Fingolimod and Fingolimod-phosphate

Description

Time Frame

Month 3 up to 36 months

Title

Change in MSFC Z-score and Subscale Scores From Baseline to Month 36

Description

Time Frame

Baseline to Month 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: General sign written informed consent prior to participating in the study 25 through 65 years of age inclusive females of childbearing potential must: have a negative pregnancy test at Baseline (prior to randomization) and use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication Primary Progressive Multiple sclerosis. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria): time since first reported symptoms between 2 and 10 years evidence of clinical disability progression in the 2 years prior to Screening disability status at Screening EDSS score of 3.5-6.0 inclusive pyramidal functional system score of 2 or more 25'TWT less than 30 seconds Extension study Inclusion criteria Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, were to have completed at least 3 years on study drug treatment at the time of extension study initiation. Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort, were to have continued on study drug treatment until such time as the last ongoing patient enrolled in the study had reached 3 years in study Exclusion Criteria: PPMS specific: History of relapses/attacks Progressive neurological disorder other than PPMS Pure cerebellar syndrome or pure visual progressive syndrome or pure cognitive progressive syndrome Presence of spinal cord compression at screening MRI Relevant history of vitamin B12 deficit Evidence of syphilis or borreliosis at Screening Cardiovascular conditions: Myocardial infarction within the past 6 months or current unstable ischemic heart disease History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon Severe cardiac failure or cardiac arrest History of symptomatic bradycardia Resting pulse <55 bpm pre-dose History of sick sinus syndrome or sino-atrial heart block History or presence of second and third degree AV block or an increase QT interval (QTc>440 ms) Arrythmia requiring treatment with class III antiarrythmic drugs History of positive tilt test from workout of vasovagal syncope Hypertension, not controlled with medication Pulmonary: Severe respiratory disease or pulmonary fibrosis TB Abnormal X-ray, suggestive of active pulmonary disease Abnormal PFT: <70% of predicted for FEV1 and FVC; <60% for DLCO Patients receiving chronic (daily) therapies for asthma Hepatic: Known history of alcohol abuse, chronic liver or biliary disease Total or conjugated Brb >ULN, unless in context of Gilbert's syndrome AP >1.5xULN; ALT/AST >2xULN; GGT>3xULN Other: History of chronic disease of the immune system other than MS Malignancy (other than successfully treated SCC or BCC) Diabetes Mellitus Macular Edema present at screening HIV, Hepatitis C or B, other active infection History of total lymphoid irradiation or bone marrow transplantation Serum creatinine >1.7 mg/dl WBC <3500 cells/mm3 Lymphocyte count <800 cells/mm3 History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures Unable to undergo MRI scans Participation in any therapeutical clinical research study in the 6 months prior to randomization Pregnant or lactating women Drugs requiring wash-out period: 3 months: Systemic corticosteroids or ACTH INF-beta 6 months: Immunosuppressive medication Immunoglobulins Monoclonal antibodies Drugs that exclude participation in the study: Cladribine Cyclophosphamide Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study) Extension study Exclusion criteria -Patients were not eligible for enrollment in the extension study if they had any of the following key exclusion criteria at the extension study Baseline visit: active chronic immune system disease other than MS (or stable disease treated with immune therapy); known immunodeficiency syndrome; active infection; uncontrolled diabetes mellitus; macularedema; treatment with Class Ia or III antiarrhythmic drugs; any of the specified cardiac, pulmonary, or hepatic conditions; or any medically unstable condition

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

Newport Beach

State/Province

California

ZIP/Postal Code

92660

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

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33060

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

Atlanta

State/Province

Georgia

ZIP/Postal Code

30302

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

Novartis Investigative Site

City

Brookline

State/Province

Massachusetts

ZIP/Postal Code

02445

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

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

Novartis Investigative Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

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

Rochester

State/Province

New York

ZIP/Postal Code

14642

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

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Novartis Investigative Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Novartis Investigative Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37934

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9034

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

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

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22904

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

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Novartis Investigative Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

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

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

Novartis Investigative Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

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

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Melsbroek

ZIP/Postal Code

1820

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sint-Truiden

ZIP/Postal Code

3800

Country

Belgium

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

T6R 2B7

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

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T 2B5

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

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

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Novartis Investigative Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J9J 0A5

Country

Canada

Facility Name

Novartis Investigative Site

City

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

H2L 4M1

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

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 1A5

Country

Canada

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Novartis Investigative Site

City

Rychnov nad Kneznou

State/Province

Czech Republic

ZIP/Postal Code

516 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

State/Province

CZE

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava-Poruba

ZIP/Postal Code

708 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

ZIP/Postal Code

301 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

ZIP/Postal Code

415 29

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aarhus

ZIP/Postal Code

8000 C

Country

Denmark

Facility Name

Novartis Investigative Site

City

Sønderborg

ZIP/Postal Code

6400

Country

Denmark

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00930

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

F-33076

Country

France

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Marseille cedex 05

ZIP/Postal Code

13385

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 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

Strasbourg

ZIP/Postal Code

67091

Country

France

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

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

D-40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Hennigsdorf

ZIP/Postal Code

16761

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Munchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Novartis Investigative Site

City

Teupitz

ZIP/Postal Code

15755

Country

Germany

Facility Name

Novartis Investigative Site

City

Trier

ZIP/Postal Code

54292

Country

Germany

Facility Name

Novartis Investigative Site

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1076

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyor

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

H-8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Facility Name

Novartis Investigative Site

City

Montichiari

State/Province

ZIP/Postal Code

25018

Country

Italy

Facility Name

Novartis Investigative Site

City

Chieti

State/Province

ZIP/Postal Code

66100

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95123

Country

Italy

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

Cefalù

State/Province

ZIP/Postal Code

90015

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00189

Country

Italy

Facility Name

Novartis Investigative Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Facility Name

Novartis Investigative Site

City

Gallarate

State/Province

ZIP/Postal Code

21013

Country

Italy

Facility Name

Novartis Investigative Site

City

Breda

State/Province

ZIP/Postal Code

4818

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

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Nijmegen

ZIP/Postal Code

6525 GC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Sittard-Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-954

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-957

Country

Poland

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

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

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Girona

State/Province

Catalunya

ZIP/Postal Code

17007

Country

Spain

Facility Name

Novartis Investigative Site

City

L'Hospitalet de Llobregat

State/Province

Catalunya

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Lleida

State/Province

Catalunya

ZIP/Postal Code

25198

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

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

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

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

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

17176

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

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

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Atakum / Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Novartis Investigative Site

City

Balcova / Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novartis Investigative Site

City

Yenisehir / Izmir

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

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

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W8 6RF

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

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

34392376

Citation

Koch MW, Mostert J, Repovic P, Bowen JD, Strijbis E, Uitdehaag B, Cutter G. Smoking, obesity, and disability worsening in PPMS: an analysis of the INFORMS original trial dataset. J Neurol. 2022 Mar;269(3):1663-1669. doi: 10.1007/s00415-021-10750-z. Epub 2021 Aug 15.

Results Reference

derived

PubMed Identifier

34376508

Citation

Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.

Results Reference

derived

PubMed Identifier

29560379

Citation

Miller DH, Lublin FD, Sormani MP, Kappos L, Yaldizli O, Freedman MS, Cree BAC, Weiner HL, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, MacManus DG, Yousry TA, Gandini Wheeler-Kingshott CAM, Li B, Putzki N, Merschhemke M, Haring DA, Wolinsky JS. Brain atrophy and disability worsening in primary progressive multiple sclerosis: insights from the INFORMS study. Ann Clin Transl Neurol. 2018 Jan 30;5(3):346-356. doi: 10.1002/acn3.534. eCollection 2018 Mar.

Results Reference

derived

PubMed Identifier

26827074

Citation

Lublin F, Miller DH, Freedman MS, Cree BAC, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, Merschhemke M, Li B, Putzki N, Liu FC, Haring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Mar 12;387(10023):1075-1084. doi: 10.1016/S0140-6736(15)01314-8. Epub 2016 Jan 28. Erratum In: Lancet. 2017 Jan 21;389(10066):254.

Results Reference

derived

PubMed Identifier

19847907

Citation

Hartung HP, Aktas O. Bleak prospects for primary progressive multiple sclerosis therapy: downs and downs, but a glimmer of hope. Ann Neurol. 2009 Oct;66(4):429-32. doi: 10.1002/ana.21880. No abstract available.

Results Reference

derived

Learn more about this trial

This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.

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This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. (INFORMS)

Primary Progressive Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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