Evaluation of Patient Reported Outcomes in RRMS Patients Candidates fo
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
- Glatiramer acetate
Unknown
Results by group
Change in Patient-reported Treatment Satisfaction
Baseline, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod | 22.69 scores on a scale | 28.12 (Standard Deviation) | 229 |
| Standard Disease Modifying Therapy (DMT) | 13.92 scores on a scale | 30.63 (Standard Deviation) | 62 |
Fingolimod
Standard Disease Modifying Therapy (DMT)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod | 230 | 2 (0.9%) | |
| Standard Disease Modifying Therapy (DMT): Interferon Beta-1a | 28 | 0 (0.0%) | |
| Standard Disease Modifying Therapy: Glatiramer Acetate | 36 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Patient-reported Treatment Satisfaction
Baseline, 6 months
Quality of life (reported by participants)Safety
Other measures (4)
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
6 months
SafetyChanges in Patient-reported Effectiveness, Side Effects and Convenience
Baseline, 6 months
Quality of life (reported by participants)SafetyChange in Patient-reported Depression
Baseline, 6 months
Mood and sleepQuality of life (reported by participants)Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)
Baseline, 6 months
PainQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 6
Show the full criteria
Inclusion criteria
* Written informed consent must be obtained before any assessment is performed. * Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2). * Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator. * Male or female patients aged 18-70 years. * An Expanded Disability Status Scale (EDSS) score of 0-6 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. * Diagnosis of macular edema during Screening Phase. * Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test. * Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline. * Patients who have received total lymphoid irradiation or bone marrow transplantation. * History of selected immune system treatments and/or medications. * Any medically unstable condition, as assessed by the investigator. * Selected cardiovascular, or hepatic conditions * Selected abnormal laboratory values. * Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion. * Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline. * History of hypersensitivity to the study drug or to drugs of similar chemical classes. * Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.
Papers
Loading reviews and guidelines…
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History
Started
Jan 2012
Main results due
Jun 2013
Finished
Jun 2013
Results posted
Aug 2014