Clinical trial NCT01317004: Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change
Official title: A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple sclerosis
Fingolimod
Disease Modifying Therapy
TSQM-9
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Patient-reported Treatment Satisfaction
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change From Baseline in Patient-reported Activities of Daily Living (ADL)
timeFrame: baseline, 6 months
measure: Change From Baseline in Patient-reported Fatigue
timeFrame: 6 months
measure: Change From Baseline in Patient-Reported Effectiveness and Convenience
timeFrame: 6 months
measure: Change From Baseline in Patient-reported Depression
timeFrame: 6 months
measure: Change From Baseline in Patient-reported Health Related Quality of Life (QOL)
timeFrame: 6 months
measure: Physician-reported Clinical Global Impression of Improvement (CGI-I)
timeFrame: 6 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Ponderano
country: Italy
facility: Novartis Investigative Site
state: BI
city: Caltanissetta
country: Italy
facility: Novartis Investigative Site
state: CL
city: Cuneo
country: Italy
facility: Novartis Investigative Site
state: CN
city: Como
country: Italy
facility: Novartis Investigative Site
state: CO
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: FG
city: Castelfiorentino
country: Italy
facility: Novartis Investigative Site
state: FI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: San Donato Milanese
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Legnago
country: Italy
facility: Novartis Investigative Site
state: VR
city: Novara
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Farma S.p.A.
name: Renato Turrini, MD
role: STUDY_DIRECTOR
References: