Adults 18 to 65, any sex, with Relapsing-remitting Multiple Sclerosis (RRMS). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Confirmed Annualized Relapse RatePrimary· up to 12 months
Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.
Group
Value
95% CI
FTY720 0.5 mg
0.153
0.111 – 0.212
FTY720 0.25 mg
0.221
0.168 – 0.290
GA 20 mg
0.258
0.196 – 0.341
New or Newly Enlarging T2 LesionsSecondary· At 12 months/end of study
Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.
Group
Value
95% CI
FTY720 0.5 mg
2.6
± 5.42
FTY720 0.25 mg
3.3
± 6.94
GA 20 mg
5.7
± 10.71
Number of Participants Free of New/Newly Enlarged T2 LesionsSecondary· At 12 months/end of study
Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.
Group
Value
95% CI
FTY720 0.5 mg
156
FTY720 0.25 mg
155
GA 20 mg
96
Change From Baseline in T2 Lesion VolumeSecondary· Baseline, 12 months/end of study
Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume
Group
Value
95% CI
FTY720 0.5 mg
-0.14
± 1.583
FTY720 0.25 mg
-0.05
± 2.340
GA 20 mg
0.42
± 2.305
Gd Enhancing T1 Lesion CountSecondary· At 12 months/end of study
Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count
Group
Value
95% CI
FTY720 0.5 mg
0.4
± 1.57
FTY720 0.25 mg
0.4
± 1.56
GA 20 mg
0.9
± 3.67
Gd Enhancing T1 Lesion VolumeSecondary· Baseline, 12 months/end of study
Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count
Baseline
Group
Value
95% CI
FTY720 0.5 mg
0.31
± 1.067
FTY720 0.25 mg
0.32
± 1.421
GA 20 mg
0.22
± 0.841
Month 12/end of study
Group
Value
95% CI
FTY720 0.5 mg
0.06
± 0.215
FTY720 0.25 mg
0.05
± 0.181
GA 20 mg
0.12
± 0.450
Percentage of Patients Free of New T1 Hypointense LesionsSecondary· 12 months
Based on MRI measures of new T1 hypointense lesions
Group
Value
95% CI
FTY720 0.5 mg
55.3
FTY720 0.25 mg
52.1
GA 20 mg
44.3
Change From Baseline in TSQM ScalesSecondary· 6 months, 12 months/end of study
Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug.
Global Satisfaction (Month 6)
Group
Value
95% CI
FTY720 0.5 mg
20.8
± 28.15
FTY720 0.25 mg
23.4
± 27.04
GA 20 mg
14.4
± 25.42
Global Satisfaction (Month 12)
Group
Value
95% CI
FTY720 0.5 mg
19.2
± 31.87
FTY720 0.25 mg
20.5
± 32.21
GA 20 mg
9.4
± 30.43
Effectiveness (Month 6)
Group
Value
95% CI
FTY720 0.5 mg
15.2
± 25.96
FTY720 0.25 mg
18.2
± 25.05
GA 20 mg
12.9
± 23.43
Effectiveness (Month 12)
Group
Value
95% CI
FTY720 0.5 mg
16.8
± 26.85
FTY720 0.25 mg
17.9
± 28.29
GA 20 mg
8.0
± 27.38
Side Effects (Month 6)
Group
Value
95% CI
FTY720 0.5 mg
16.9
± 31.58
FTY720 0.25 mg
18.8
± 30.63
GA 20 mg
9.3
± 31.94
Side Effects (Month 12)
Group
Value
95% CI
FTY720 0.5 mg
16.2
± 31.52
FTY720 0.25 mg
17.2
± 32.52
GA 20 mg
7.6
± 32.76
Convenience (Month 6)
Group
Value
95% CI
FTY720 0.5 mg
30.7
± 25.76
FTY720 0.25 mg
26.5
± 25.93
GA 20 mg
4.4
± 20.73
Convenience (Month 12)
Group
Value
95% CI
FTY720 0.5 mg
29.5
± 24.42
FTY720 0.25 mg
26.5
± 26.36
GA 20 mg
0.8
± 25.72
Percent Brain Volume Change From BaselineSecondary· Baseline, 12 months, end of study
Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.
Group
Value
95% CI
FTY720 0.5 mg
-0.652
± 0.7810
FTY720 0.25 mg
-0.636
± 0.8097
GA 20 mg
-0.561
± 0.7819
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Fingolimod 0.5 mg
Serious: 25/345 (7%)
Deaths: 0/345
FTY 0.25 mg
Serious: 32/366 (9%)
Deaths: 0/366
GA 20 mg
Serious: 20/324 (6%)
Deaths: 0/324
All@Patients
Serious: 77/1035 (7%)
Deaths: 0/1035
Serious adverse events (83 terms)
Reaction
System
Fingolimod 0.5 mg
FTY 0.25 mg
GA 20 mg
All@Patients
Multiple sclerosis relapse
Nervous system disorders
—
—
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02720107 — Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)
· Phase 4
· completed
NCT02342704 — Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
· Phase 4
· terminated
Other recruiting trials for Relapsing-remitting Multiple Sclerosis (RRMS)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 28 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01633112.