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Long-term Follow-up of Fingolimod Phase II Study Patients (ACROSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307838
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Intervention Other: Assessments arm
Enrollment 177
Recruitment Details This extension study was a multicenter follow-up study of participants who enrolled in FTY720D2201 (NCT02307838). Although participants in this study did not receive study treatment, the participant flow is based on the treatments receive in FTY720D2201.
Pre-assignment Details A total of 177 participants were enrolled into the study. However, 2 participants were erroneously enrolled into the study because they did not meet the inclusion criteria. Therefore, they were not included in any analyses, and as such, the participant flow is based on 175 participants.
Arm/Group Title FTY720 5.0 mg FTY720 1.25 mg Placebo
Hide Arm/Group Description In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months. In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months. In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.
Period Title: Overall Study
Started 56 64 55
Completed 56 64 55
Not Completed 0 0 0
Arm/Group Title Continuous Non-continuous Non-continuous: Other DMTs Total
Hide Arm/Group Description Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all. Total of all reporting groups
Overall Number of Baseline Participants 104 16 55 175
Hide Baseline Analysis Population Description
For baseline characteristics and analyses, participants were grouped according to FTY720 exposure: Continuous >= 8 years of FTY720 and Non-continuous < 8 years of FTY720. Non-continuous groups were broken down according to the high-efficacy DMTs' exposure. DMTs included natalizumab, mitoxantrone, alemtuzumab, rituximab, cladribine or ocrelizumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 16 participants 55 participants 175 participants
37.4  (8.47) 31.9  (9.05) 38.9  (10.49) 37.4  (9.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 16 participants 55 participants 175 participants
Female
63
  60.6%
13
  81.3%
41
  74.5%
117
  66.9%
Male
41
  39.4%
3
  18.8%
14
  25.5%
58
  33.1%
1.Primary Outcome
Title Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)
Hide Description EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) 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. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.
Time Frame baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 104 71
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.58  (0.154) 1.17  (0.185)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous, Non-continuous
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0155
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-1.07 to -0.11
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Disability Progression
Hide Description Disability progression is defined as: 1.5-point increase from baseline in participants with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in participants with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in participants with baseline EDSS score >5.0.
Time Frame 10 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous: High Efficacy DMTs Non-continuous: Other DMTs
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Overall Number of Participants Analyzed 104 16 55
Measure Type: Number
Unit of Measure: Participants
35 8 29
3.Secondary Outcome
Title Number of Participants With EDSS <4 or <6
Hide Description EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) 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. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A positive change from baseline indicates improvement.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous: High Efficacy DMTs Non-continuous: Other DMTs
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Overall Number of Participants Analyzed 104 16 55
Measure Type: Number
Unit of Measure: Participants
EDSS <4 78 10 31
EDSS <6 90 13 41
4.Secondary Outcome
Title Number of Participants Not Using a Wheelchair or Being Bedridden
Hide Description The number of participants not using a wheelchair or being bedridden was assessed.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous: High Efficacy DMTs Non-continuous: Other DMTs
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Overall Number of Participants Analyzed 104 16 55
Measure Type: Number
Unit of Measure: Participants
99 13 46
5.Secondary Outcome
Title Number of Participants Classified as Secondary Progressive MS (SPMS)
Hide Description SPMS follows an initial relapsing-remitting course. Most people who are diagnosed with relapsing-remitting multiple sclerosis (RRMS) will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. Participants who were classified as SPMS were assessed.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous: High Efficacy DMTs Non-continuous: Other DMTs
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Overall Number of Participants Analyzed 104 16 55
Measure Type: Number
Unit of Measure: Participants
10 2 14
6.Secondary Outcome
Title Percentage of Participants With First Use of an Ambulatory Device
Hide Description First use of an ambulatory device was considered from EDSS 6.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 6.0.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for the analysis. Only participants with evaluable data were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 103 69
Measure Type: Number
Unit of Measure: Percentage of participants
12.4 17.6
7.Secondary Outcome
Title Percentage of Participants With First Use of a Wheelchair
Hide Description First use of a wheelchair was considered from EDSS 7.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 7.0.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 104 71
Measure Type: Number
Unit of Measure: Percentage of participants
4.9 16.9
8.Secondary Outcome
Title Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)
Hide Description The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and non-dominant hands are tested twice (two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand). The time limit per trial is 300 seconds. The right and left hand scores were the time in seconds it took to insert and remove 9 pegs ((the average scores from the four trials on the 9-HPT (the two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged)). A negative change from baseline indicates improvement.
Time Frame baseline from core study, CFTY720D2201 (NCT00333138), 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 104 71
Mean (Standard Deviation)
Unit of Measure: seconds
2.29  (5.772) 5.06  (14.523)
9.Secondary Outcome
Title Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score
Hide Description The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is the last measure administered at each visit. It is presented on audio compact disc (CD) to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test result is the number of correct sums given (out of 60 possible). A positive change from baseline indicates improvement.
Time Frame baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 104 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.54  (8.273) -5.39  (12.428)
10.Secondary Outcome
Title Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score
Hide Description The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. A negative change from baseline indicates improvement.
Time Frame baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 104 70
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.32  (11.632) 3.89  (16.070)
11.Secondary Outcome
Title Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score
Hide Description MSFC is a composite measure encompassing information from the nine-hole peg test (arm dimension), timed 25 foot walk (leg dimension) and PASAT. The MSFC composite Z score was calculated as follows: (1) the average scores from the four trials on the 9-HPT (the two trials for each hand were averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals were averaged); (2) the average scores of two 25-Foot Timed Walk trials; (3) the number correct from the PASAT-3. The MSFC is based on the concept that scores for these three dimensions-arm, leg, and cognitive function are combined to create a single score (the MSFC) that can be used to detect change over time in a group of multiple sclerosis patients. This was done by creating Z-scores for each component of the MSFC, and averaging them to create an overall composite Z score.
Time Frame baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for the analysis. Only participants with both baseline measurements for each MSFC component and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 104 69
Mean (Standard Deviation)
Unit of Measure: Z score
-0.11  (0.536) -0.60  (1.297)
12.Secondary Outcome
Title Total Volume in T2 Lesion
Hide Description Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI).
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for the analysis. Only participants with measurements at 10 years were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 98 54
Mean (Standard Deviation)
Unit of Measure: mm^3
8685.4  (7743.05) 11279.0  (12570.11)
13.Secondary Outcome
Title Change From Baseline in Total Volume of T2 Lesion
Hide Description Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
Time Frame baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for the analysis. Only participants from the FAS who had both baseline and 10 years measurements were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 96 53
Mean (Standard Deviation)
Unit of Measure: mm^3
1031.7  (3725.80) 3636.7  (5259.84)
14.Secondary Outcome
Title Third Ventricle Diameter
Hide Description Third ventricle diameter was assessed by MRI.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for the analysis. Only participants with 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 97 56
Mean (Standard Deviation)
Unit of Measure: mm
5.28  (2.047) 5.57  (2.648)
15.Secondary Outcome
Title Change From Baseline in Third Ventricle Diameter
Hide Description Third ventricle diameter was assessed by MRI. A negative change from baseline indicates improvement.
Time Frame baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for analysis. Only participants who had both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 95 55
Mean (Standard Deviation)
Unit of Measure: mm
0.80  (0.848) 0.92  (0.784)
16.Secondary Outcome
Title Percentage Brain Volume Change (PBVC)
Hide Description PVBC was assessed by MRI. A negative change from baseline indicates improvement.
Time Frame baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 85 48
Mean (Standard Deviation)
Unit of Measure: Percent change
-9.28  (4.412) -9.87  (2.909)
17.Secondary Outcome
Title Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters
Hide Description The correlation between FTY treatment duration and disability progression outcomes was assessed. The number presented in the table is the Pearson correlation coefficient, r.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was considered for the analysis. Only participants who had 10 year correlation measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.
Arm/Group Title Continuous Non-continuous
Hide Arm/Group Description:
Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed 104 71
Measure Type: Number
Unit of Measure: Pearson correlation coeffcient
EDSS score at year 10 (n=101,71) -0.12 -0.09
Time to 1st use of a cane/crutch/walker (n=13,15) 0.35 0.11
Time to first documenting EDSS of >= 6.0 (n=12,11) 0.27 0.00
Time to first use of a wheelchair (n=5,12) 0.57 0.33
Time to first becoming bedridden (n=0,0) NA [1]  NA [1] 
Time to first SPMS classification (n=10,16) 0.38 0.32
Year 10 PASAT-3 score (n=93,56) -0.14 0.28
Year 10 PASAT-3 score change from BL (n=93,56) 0.01 0.39
[1]
No participants had become bedridden.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuous Non-continuous: High Efficacy DMTs Non-continuous: Other DMTs
Hide Arm/Group Description Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy disease modifying therapies (DMTs) for at least 2 years. Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
All-Cause Mortality
Continuous Non-continuous: High Efficacy DMTs Non-continuous: Other DMTs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Continuous Non-continuous: High Efficacy DMTs Non-continuous: Other DMTs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      0/16 (0.00%)      0/55 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Non-continuous: High Efficacy DMTs Non-continuous: Other DMTs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      0/16 (0.00%)      1/55 (1.82%)    
Nervous system disorders       
Multiple sclerosis relapse  1  0/104 (0.00%)  0 0/16 (0.00%)  0 1/55 (1.82%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02307838    
Other Study ID Numbers: CFTY720D2201E2
First Submitted: May 14, 2014
First Posted: December 4, 2014
Results First Submitted: November 28, 2016
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017