Trial Outcomes & Findings for Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis. (NCT NCT01623596)
NCT ID: NCT01623596
Last Updated: 2021-01-05
Results Overview
Comparison effectiveness of fingolimod versus approved first-line disease modifying therapies by measuring the rate of participant retention on randomized treatment over a 12-month period (Full analysis set)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
881 participants
Primary outcome timeframe
at 12 months
Results posted on
2021-01-05
Participant Flow
62 Fingolimod arm participants discontinued: 57 discontinued before treatment switch, and 5 discontinued after treatment switch 100 MS-DMT arm participants discontinued before treatment switch: 57 discontinued before treatment switch, and 43 discontinued after treatment switch
Patient disposition was summarized on the Randomized Set. Randomized Set (RS): consists of all participants who were assigned randomization numbers.
Participant milestones
| Measure |
Fingolimod
fingolimod 0.5 mg once a day
|
Disease Modifying Therapy
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|
|---|---|---|
|
Overall Study
STARTED
|
436
|
439
|
|
Overall Study
On Randomized Treatment
|
352
|
125
|
|
Overall Study
On Switched Treatment
|
22
|
214
|
|
Overall Study
COMPLETED
|
374
|
339
|
|
Overall Study
NOT COMPLETED
|
62
|
100
|
Reasons for withdrawal
| Measure |
Fingolimod
fingolimod 0.5 mg once a day
|
Disease Modifying Therapy
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|
|---|---|---|
|
Overall Study
Abnormal laboratory values
|
2
|
0
|
|
Overall Study
Administrative problems
|
9
|
13
|
|
Overall Study
Adverse Event
|
20
|
29
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
12
|
16
|
|
Overall Study
Withdrawal by Subject
|
13
|
31
|
|
Overall Study
Patient no longer requires study drug
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
6
|
|
Overall Study
Lack of Efficacy
|
5
|
3
|
Baseline Characteristics
Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.
Baseline characteristics by cohort
| Measure |
Fingolimod
n=436 Participants
fingolimod 0.5 mg once a day
|
Disease Modifying Therapy (MS_DMT)
n=439 Participants
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|
Total
n=875 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 10.39 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
311 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
640 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 12 monthsPopulation: Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.
Comparison effectiveness of fingolimod versus approved first-line disease modifying therapies by measuring the rate of participant retention on randomized treatment over a 12-month period (Full analysis set)
Outcome measures
| Measure |
Fingolimod
n=436 Participants
fingolimod 0.5 mg once a day
|
Disease Modifying Therapy (MS-DMT)
n=439 Participants
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|
|---|---|---|
|
Participant Retention Rate Over 12 Months
|
352 participants
|
125 participants
|
SECONDARY outcome
Timeframe: at 12 monthsPopulation: Randomized set (RS): consists of all patients who were assigned randomization numbers. The patients in this set were called randomized patients. This set was used to summarize patient disposition, demographic and baseline characteristics, and protocol deviation information. Patients were grouped according to randomized treatment.
Reasons for discontinuation in participants treated with fingolimod vs. DMT over 12 months of treatment Total discontinued (Primary reason): Fingolimod arm: 27, MS-DMT arm: 27 = 54 participants Total discontinued (Secondary reason): Fingolimod arm: 257, MS-DMT arm: 256 = 513 participants Throughout the study, investigators evaluated each patient for occurrence of randomized treatment discontinuation and determined the primary and secondary reasons for such discontinuation. At every visit, the investigator evaluated the patients and determined if they should continue on randomized treatment or change to alternative treatment. Treatment discontinuation was a clinically meaningful measure related to safety, efficacy, and tolerability over time, reflecting the therapeutic effectiveness of study treatment.
Outcome measures
| Measure |
Fingolimod
n=436 Participants
fingolimod 0.5 mg once a day
|
Disease Modifying Therapy (MS-DMT)
n=439 Participants
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|
|---|---|---|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Occurrence of relapse (Primary reason)
|
5 participants
|
14 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Depression (Primary reason)
|
1 participants
|
4 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Flu-like symptoms (Secondary reason)
|
1 participants
|
16 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Macular edema (Secondary reason)
|
1 participants
|
0 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Inconvenient administration (Secondary reason)
|
0 participants
|
55 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Disease activity present in MRI (Primary reason)
|
0 participants
|
6 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Injection site reaction (Primary reason)
|
0 participants
|
61 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Flu-like symptoms (Primary reason)
|
0 participants
|
34 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Lipoatrophy (Primary reason)
|
0 participants
|
1 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Hepatic side effects (Primary reason)
|
7 participants
|
3 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Spasticity (Primary reason)
|
0 participants
|
1 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Infection (Primary reason)
|
0 participants
|
0 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Macular edema (Primary reason)
|
1 participants
|
0 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Bradycardia (Primary reason)
|
0 participants
|
0 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Needle phobia (Primary reason)
|
0 participants
|
13 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Inconvenient administration (Primary reason)
|
0 participants
|
33 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Frequency of injections (Primary reason)
|
0 participants
|
29 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Neutralizing antibodies present (Primary reason)
|
0 participants
|
0 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Other (Primary reason)
|
13 participants
|
58 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Occurrence of relapse (Secondary reason)
|
0 participants
|
3 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Disease activity present in MRI (Secondary reason)
|
2 participants
|
5 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Injection site reaction (Secondary reason)
|
0 participants
|
40 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Lipoatrophy (Secondary reason)
|
0 participants
|
1 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Depression (Secondary reason)
|
0 participants
|
6 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Hepatic side effects (Secondary reason)
|
5 participants
|
0 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Spasticity (Secondary reason)
|
1 participants
|
2 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Infection (Secondary reason)
|
0 participants
|
0 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Bradycardia (Secondary reason)
|
0 participants
|
0 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Needle phobia (Secondary reason)
|
0 participants
|
18 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Frequency of injections (Secondary reason)
|
0 participants
|
45 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Neutralizing antibodies present (Secondary reason)
|
0 participants
|
0 participants
|
|
Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set
Other (Secondary reason)
|
17 participants
|
65 participants
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 months, and Last assessment which is either at Month 12 or at early discontinuationPopulation: Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.
Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. NOTE: Higher scores indicate better performance.
Outcome measures
| Measure |
Fingolimod
n=433 Participants
fingolimod 0.5 mg once a day
|
Disease Modifying Therapy (MS-DMT)
n=428 Participants
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|
|---|---|---|
|
Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)
Change at Last assessment (n=73, 65)
|
3.30 SDMT score
Standard Deviation 7.77
|
0.40 SDMT score
Standard Deviation 9.47
|
|
Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)
Baseline (n=76,70)
|
52.00 SDMT score
Standard Deviation 12.12
|
51.60 SDMT score
Standard Deviation 13.40
|
|
Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)
Change at 6 months (n=70,64)
|
2.20 SDMT score
Standard Deviation 8.09
|
0.20 SDMT score
Standard Deviation 10.13
|
|
Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)
Change at 12 months (n=58, 18)
|
3.20 SDMT score
Standard Deviation 7.09
|
1.40 SDMT score
Standard Deviation 8.33
|
SECONDARY outcome
Timeframe: baseline, 6 months, 12 months, Last assessment which is either at Month 12 or at early discontinuationPopulation: Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.
Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. NOTE: Higher scores indicate better performance.
Outcome measures
| Measure |
Fingolimod
n=433 Participants
fingolimod 0.5 mg once a day
|
Disease Modifying Therapy (MS-DMT)
n=428 Participants
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|
|---|---|---|
|
Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)
Baseline (n=355,348)
|
48.90 SDMT score
Standard Deviation 18.26
|
48.50 SDMT score
Standard Deviation 20.19
|
|
Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)
Change at 6 months (n=339,322)
|
-0.50 SDMT score
Standard Deviation 14.04
|
0.70 SDMT score
Standard Deviation 13.16
|
|
Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)
Change at 12 months (n=282,105)
|
0.70 SDMT score
Standard Deviation 16.02
|
0.40 SDMT score
Standard Deviation 14.90
|
|
Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)
Change at Last assessment (n=342, 324)
|
0.80 SDMT score
Standard Deviation 16.27
|
0.70 SDMT score
Standard Deviation 13.95
|
SECONDARY outcome
Timeframe: 12 months, and Last assessment which is either at Month 12 or at early discontinuationPopulation: Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.
Summary statistics for percent change from month 12 in brain volume by visit (Randomized treatment / randomized phase) in patients treated with fingolimod vs.DMTs as measured by MRI
Outcome measures
| Measure |
Fingolimod
n=433 Participants
fingolimod 0.5 mg once a day
|
Disease Modifying Therapy (MS-DMT)
n=428 Participants
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|
|---|---|---|
|
Percent Change From Baseline in Brain Volume From Month 12 to Last Visit (Randomized)
Percent change at 12 months (n=323, 111)
|
-0.396 percent change in brain volume
Standard Deviation 0.7825
|
-0.555 percent change in brain volume
Standard Deviation 0.7181
|
|
Percent Change From Baseline in Brain Volume From Month 12 to Last Visit (Randomized)
Percent change at Last assessment (n=370, 246)
|
-0.385 percent change in brain volume
Standard Deviation 0.7690
|
-0.420 percent change in brain volume
Standard Deviation 0.6423
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, 9 months, at 12 months & Last assessment during randomized phase which is either at Month 12 or at early discontinuationPopulation: Full analysis set (FAS) includes all the patients who received at least one dose of study medication and had information on the primary end point.
Summary statistics for Medication Satisfaction Questionnaire\[Question: "Overall, how satisfied are you with your current medication?"\] (Randomized treatment / randomized phase): Fingolimod vs MS-DMT
Outcome measures
| Measure |
Fingolimod
n=433 Participants
fingolimod 0.5 mg once a day
|
Disease Modifying Therapy (MS-DMT)
n=428 Participants
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|
|---|---|---|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
1 month, Somewhat dissatisfied
|
8 participants
1.9
|
52 participants
12.4
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
1 month, Neither dissatisfied nor satisfied
|
32 participants
7.5
|
74 participants
17.7
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Baseline, Extremely dissatisfied
|
10 participants
4.7
|
16 participants
7.2
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Baseline, Very dissatisfied
|
22 participants
10.3
|
13 participants
5.8
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Baseline, Somewhat dissatisfied
|
29 participants
13.6
|
39 participants
17.5
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Baseline, Neither dissatisfied nor satisfied
|
62 participants
29.0
|
61 participants
27.4
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Baseline, Somewhat satisfied
|
35 participants
16.4
|
46 participants
20.6
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Baseline, Very satisfied
|
42 participants
19.6
|
31 participants
13.9
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Baseline, Extremely satisfied
|
14 participants
6.5
|
17 participants
7.6
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Baseline, Missing
|
219 participants
0
|
205 participants
0
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
1 month, Extremely dissatisfied
|
8 participants
1.9
|
29 participants
6.9
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
1 month, Very dissatisfied
|
14 participants
3.3
|
37 participants
8.9
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
1 month, Somewhat satisfied
|
52 participants
12.1
|
89 participants
21.3
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
1 month, Very satisfied
|
161 participants
37.5
|
97 participants
23.2
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
1 month, Extremely satisfied
|
154 participants
35.9
|
40 participants
9.6
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
1 month, Missing
|
4 participants
0
|
10 participants
0
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
3 months, Extremely dissatisfied
|
5 participants
1.2
|
19 participants
5.5
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
3 months, Very dissatisfied
|
11 participants
2.7
|
38 participants
11.0
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
3 months, Somewhat dissatisfied
|
11 participants
2.7
|
42 participants
12.1
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
3 months, Neither dissatisfied nor satisfied
|
46 participants
11.1
|
53 participants
15.3
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
3 months, Somewhat satisfied
|
43 participants
10.4
|
73 participants
21.1
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
3 months, Very satisfied
|
153 participants
37.0
|
91 participants
26.3
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
3 months, Extremely satisfied
|
144 participants
34.9
|
30 participants
8.7
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
3 months, Missing
|
20 participants
0
|
82 participants
0
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
6 months, Extremely dissatisfied
|
8 participants
2.0
|
9 participants
4.6
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
6 months, Very dissatisfied
|
15 participants
3.8
|
11 participants
5.6
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
6 months, Somewhat dissatisfied
|
11 participants
2.8
|
13 participants
6.6
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
6 months, Neither dissatisfied nor satisfied
|
25 participants
6.3
|
24 participants
12.2
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
6 months, Somewhat satisfied
|
57 participants
14.4
|
46 participants
23.5
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
6 months, Very satisfied
|
130 participants
32.7
|
67 participants
34.2
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
6 months, Extremely satisfied
|
151 participants
38.0
|
26 participants
13.3
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
6 months, Missing
|
36 participants
0
|
232 participants
0
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
9 months, Extremely dissatisfied
|
7 participants
1.9
|
4 participants
2.6
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
9 months, Very dissatisfied
|
8 participants
2.2
|
6 participants
3.9
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
9 months, Somewhat dissatisfied
|
12 participants
3.2
|
12 participants
7.8
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
9 months, Neither dissatisfied nor satisfied
|
21 participants
5.7
|
15 participants
9.8
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
9 months, Somewhat satisfied
|
42 participants
11.4
|
29 participants
19.0
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
9 months, Very satisfied
|
135 participants
36.5
|
58 participants
37.9
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
9 months, Extremely satisfied
|
145 participants
39.2
|
29 participants
19.0
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
9 months, Missing
|
63 participants
0
|
275 participants
0
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
12 months, Extremely dissatisfied
|
7 participants
2.0
|
3 participants
2.4
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
12 months, Very dissatisfied
|
7 participants
2.0
|
4 participants
3.1
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
12 months, Somewhat dissatisfied
|
11 participants
3.1
|
4 participants
3.1
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
12 months, Neither dissatisfied nor satisfied
|
27 participants
7.7
|
8 participants
6.3
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
12 months, Somewhat satisfied
|
34 participants
9.7
|
22 participants
7.3
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
12 months, Very satisfied
|
115 participants
32.8
|
60 participants
47.2
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
12 months, Extremely satisfied
|
150 participants
42.7
|
26 participants
20.5
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
12 months, Missing
|
82 participants
0
|
301 participants
0
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Last assessment, Extremely dissatisfied
|
14 participants
3.3
|
46 participants
10.9
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Last assessment, Very dissatisfied
|
15 participants
3.5
|
61 participants
14.5
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Last assessment, Somewhat dissatisfied
|
23 participants
5.3
|
57 participants
13.5
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Last assessment,Neither dissatisfied nor satisfied
|
45 participants
10.5
|
58 participants
13.7
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Last assessment, Somewhat satisfied
|
43 participants
10.0
|
69 participants
16.4
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Last assessment, Very satisfied
|
128 participants
29.8
|
94 participants
22.3
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Last assessment, Extremely satisfied
|
162 participants
37.7
|
37 participants
8.8
|
|
Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score
Last assessment, Missing
|
3 participants
0
|
6 participants
0
|
Adverse Events
Fingolimod
Serious events: 29 serious events
Other events: 282 other events
Deaths: 0 deaths
MS DMT
Serious events: 15 serious events
Other events: 291 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fingolimod
n=433 participants at risk
Fingolimod
|
MS DMT
n=428 participants at risk
MS DMT
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/433
|
0.23%
1/428
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/433
|
0.00%
0/428
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.23%
1/433
|
0.00%
0/428
|
|
Cardiac disorders
Bradycardia
|
0.23%
1/433
|
0.00%
0/428
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/433
|
0.23%
1/428
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/433
|
0.00%
0/428
|
|
Eye disorders
Macular oedema
|
0.23%
1/433
|
0.00%
0/428
|
|
Eye disorders
Visual impairment
|
0.23%
1/433
|
0.00%
0/428
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/433
|
0.23%
1/428
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.23%
1/433
|
0.00%
0/428
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.23%
1/433
|
0.00%
0/428
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/433
|
0.00%
0/428
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
1/433
|
0.00%
0/428
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/433
|
0.23%
1/428
|
|
Gastrointestinal disorders
Jejunal ulcer
|
0.23%
1/433
|
0.00%
0/428
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.23%
1/433
|
0.00%
0/428
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/433
|
0.23%
1/428
|
|
General disorders
Asthenia
|
0.23%
1/433
|
0.00%
0/428
|
|
General disorders
Localised oedema
|
0.23%
1/433
|
0.00%
0/428
|
|
General disorders
Systemic inflammatory response syndrome
|
0.23%
1/433
|
0.00%
0/428
|
|
Hepatobiliary disorders
Biliary colic
|
0.23%
1/433
|
0.00%
0/428
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/433
|
0.23%
1/428
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/433
|
0.23%
1/428
|
|
Infections and infestations
Bacteraemia
|
0.23%
1/433
|
0.00%
0/428
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.23%
1/433
|
0.00%
0/428
|
|
Infections and infestations
Cellulitis
|
0.23%
1/433
|
0.00%
0/428
|
|
Infections and infestations
Pneumonia
|
0.46%
2/433
|
0.00%
0/428
|
|
Infections and infestations
Pneumonia influenzal
|
0.23%
1/433
|
0.00%
0/428
|
|
Infections and infestations
Pyelonephritis acute
|
0.23%
1/433
|
0.00%
0/428
|
|
Infections and infestations
Tooth abscess
|
0.23%
1/433
|
0.00%
0/428
|
|
Infections and infestations
Viral infection
|
0.23%
1/433
|
0.00%
0/428
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.23%
1/433
|
0.00%
0/428
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/433
|
0.23%
1/428
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.23%
1/433
|
0.00%
0/428
|
|
Injury, poisoning and procedural complications
Seroma
|
0.23%
1/433
|
0.00%
0/428
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.23%
1/433
|
0.00%
0/428
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.23%
1/433
|
0.00%
0/428
|
|
Metabolism and nutrition disorders
Dehydration
|
0.46%
2/433
|
0.00%
0/428
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.23%
1/433
|
0.00%
0/428
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.23%
1/433
|
0.00%
0/428
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.23%
1/433
|
0.00%
0/428
|
|
Nervous system disorders
Dizziness
|
0.00%
0/433
|
0.23%
1/428
|
|
Nervous system disorders
Headache
|
0.23%
1/433
|
0.00%
0/428
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/433
|
0.23%
1/428
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/433
|
0.23%
1/428
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/433
|
0.23%
1/428
|
|
Nervous system disorders
Multiple sclerosis relapse
|
1.2%
5/433
|
1.2%
5/428
|
|
Nervous system disorders
Optic neuritis
|
0.23%
1/433
|
0.00%
0/428
|
|
Nervous system disorders
Paraesthesia
|
0.23%
1/433
|
0.00%
0/428
|
|
Nervous system disorders
Sciatica
|
0.00%
0/433
|
0.23%
1/428
|
|
Nervous system disorders
Syncope
|
0.23%
1/433
|
0.00%
0/428
|
|
Psychiatric disorders
Agoraphobia
|
0.00%
0/433
|
0.23%
1/428
|
|
Psychiatric disorders
Anxiety
|
0.23%
1/433
|
0.47%
2/428
|
|
Psychiatric disorders
Depression
|
0.23%
1/433
|
0.00%
0/428
|
|
Psychiatric disorders
Homicidal ideation
|
0.23%
1/433
|
0.00%
0/428
|
|
Psychiatric disorders
Major depression
|
0.23%
1/433
|
0.00%
0/428
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/433
|
0.23%
1/428
|
|
Psychiatric disorders
Personality disorder
|
0.00%
0/433
|
0.23%
1/428
|
|
Psychiatric disorders
Suicidal ideation
|
0.46%
2/433
|
0.00%
0/428
|
|
Renal and urinary disorders
Calculus urinary
|
0.23%
1/433
|
0.00%
0/428
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/433
|
0.23%
1/428
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.23%
1/433
|
0.00%
0/428
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.23%
1/433
|
0.00%
0/428
|
|
Surgical and medical procedures
Abortion induced
|
0.23%
1/433
|
0.23%
1/428
|
|
Vascular disorders
Haematoma
|
0.23%
1/433
|
0.00%
0/428
|
Other adverse events
| Measure |
Fingolimod
n=433 participants at risk
Fingolimod
|
MS DMT
n=428 participants at risk
MS DMT
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.9%
30/433
|
0.23%
1/428
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
26/433
|
1.2%
5/428
|
|
Gastrointestinal disorders
Nausea
|
6.7%
29/433
|
5.1%
22/428
|
|
General disorders
Fatigue
|
11.3%
49/433
|
7.7%
33/428
|
|
General disorders
Influenza like illness
|
2.8%
12/433
|
15.0%
64/428
|
|
General disorders
Injection site erythema
|
0.00%
0/433
|
9.8%
42/428
|
|
General disorders
Injection site pain
|
0.00%
0/433
|
14.5%
62/428
|
|
General disorders
Injection site pruritus
|
0.00%
0/433
|
7.0%
30/428
|
|
General disorders
Injection site reaction
|
0.00%
0/433
|
11.7%
50/428
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
41/433
|
5.1%
22/428
|
|
Infections and infestations
Sinusitis
|
6.5%
28/433
|
4.9%
21/428
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
27/433
|
4.9%
21/428
|
|
Infections and infestations
Urinary tract infection
|
5.3%
23/433
|
3.7%
16/428
|
|
Investigations
Lymphocyte count decreased
|
5.3%
23/433
|
0.00%
0/428
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
30/433
|
4.0%
17/428
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
29/433
|
3.3%
14/428
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
18/433
|
5.4%
23/428
|
|
Nervous system disorders
Dizziness
|
7.2%
31/433
|
2.8%
12/428
|
|
Nervous system disorders
Headache
|
9.2%
40/433
|
9.6%
41/428
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
23/433
|
3.5%
15/428
|
|
Nervous system disorders
Migraine
|
5.1%
22/433
|
3.3%
14/428
|
|
Nervous system disorders
Paraesthesia
|
5.1%
22/433
|
4.0%
17/428
|
|
Psychiatric disorders
Anxiety
|
3.0%
13/433
|
5.6%
24/428
|
|
Psychiatric disorders
Depression
|
6.0%
26/433
|
6.8%
29/428
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
25/433
|
3.5%
15/428
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: (862) 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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 (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER