Phase 4
N=65
Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change
Relapsing Remitting Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01317004 ↗Enrolled (actual)
65
Serious AEs
8.2%
Results posted
Jun 2015
Primary outcome: Primary: Change From Baseline in Patient-reported Treatment Satisfaction — 19.57; 5.83 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fingolimod (Drug); Standard MS DMT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Patient-reported Treatment Satisfaction |
19.57; 5.83 | — |
| SECONDARY Change From Baseline in Patient-reported Activities of Daily Living (ADL) |
0.19; 0.15 | — |
| SECONDARY Change From Baseline in Patient-reported Fatigue |
-0.18; -0.32 | — |
| SECONDARY Change From Baseline in Patient-Reported Effectiveness and Convenience |
13.53; -1.67; 24.64; 12.78 | — |
| SECONDARY Change From Baseline in Patient-reported Depression |
-1.15; -0.12 | — |
| SECONDARY Change From Baseline in Patient-reported Health Related Quality of Life (QOL) |
1.71; -1.11; 7.14; 5.56; 6.56; 14.44 | — |
| SECONDARY Physician-reported Clinical Global Impression of Improvement (CGI-I) |
13.64; 11.11; 36.36; 11.11; 47.73; 66.67 | — |
Summary
The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Eligibility Criteria
Inclusion Criteria
- Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
- Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
- An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.
- Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
- Naïve to treatment with fingolimod.
Exclusion Criteria
- A manifestation of MS other than those defined in the inclusion criteria.
- A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
- Diagnosis of macular edema during Screening Phase.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01317004). 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.