Phase 4
Completed N=1,053
A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis
Relapsing Forms of Multiple Sclerosis
Source: ClinicalTrials.gov NCT01216072 ↗
Enrolled (actual)
1,053
Serious AEs
3.5%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 — 22.5; 3.5 units on a scale
Summary
The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 |
22.5; 3.5 | — |
| SECONDARY Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death |
617; 152; 123; 31; 5; 7 | — |
| SECONDARY Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6 |
-0.6; -0.2 | — |
| SECONDARY Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS) |
-0.3; 0.0; -0.4; 0.0 | — |
| SECONDARY Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4 |
15.5; 2.8 | — |
| SECONDARY Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4 |
22.9; 3.5 | — |
| SECONDARY Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4 |
41.8; 1.5 | — |
| SECONDARY Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2) |
1.5; 0.4; 2.8; 1.2; 2.0; -0.3 | — |
| SECONDARY Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II) |
-3.2; -0.8; -3.4; -0.6 | — |
| SECONDARY Physician-reported Clinical Global Impression of Improvement (CGI-I) |
3.4; 3.9; 3.2; 3.9 | — |
Eligibility Criteria
Inclusion Criteria
- Relapsing forms of MS
- Expanded Disability Status Scale (EDSS) 0-5.5
- Continuous treatment with MS DMT for a minimum of 6 months
- Fingolimod naive
Exclusion Criteria
- Immune system diseases other than MS
- Active macular edema
- History of selected prior infections and criteria for immunizations
- History of selected immune system treatments and/or medications
- Selected cardiovascular, pulmonary, or hepatic conditions
- Selected abnormal laboratory values
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria applied
Data sourced from ClinicalTrials.gov (NCT01216072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.