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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2011
INTERVENTION: Product Name: FINGOLIMOD Product Code: FTY720D Pharmaceutical Form: Capsule, hard CAS Number: 162359‐56‐0 Current Sponsor code: FTY720D Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .5‐ Trade Name: EXTAVIA Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Interferon beta‐1b Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 250‐ Trade Name: AVONEX Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Interferon beta‐1a Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 30‐ Trade Name: COPAXONE Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Glatiramer acetate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ CONDITION: Relapsing Remitting Multiple Sclerosis ; MedDRA version: 9.1 Level: LLT Classification code 10063399 PRIMARY OUTCOME: Main Objective: The primary objective of the 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). Primary end point(s): The primary objective of the 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). Secondary Objective: To evaluate in patients who have been previously treated for RRMS:safety and tolerability immediately after a change in DMT and during 6 months of treatment with fingolimod vs.DMT standard of care in patients who have been previously treated for RRMS; the change in patient‐reported ADL with fingolimod vs.DMT standard of care, using the PRIMUS‐Activities;the change in patient‐reported fatigue with fingolimod vs.DMT standard of care, using the Fatigue Severity Scale (FSS);changes in patient–reported effectiveness and convenience subscales with fingolimod vs.DMT standard of care, using the TSQM‐9;the change in patient‐reported depression with fingolimod vs. DMT standard of care, using the BDI‐FS;the change in patient‐reported health‐related quality‐of‐life with fingolimod vs.DMT standard of care, using the SF‐36 v1.To measure the physician‐reported CGI‐I with fingolimod vs DMT standard of care in patients who have been previously treated for RRMS INCLUSION CRITERIA: 1.Written informed consent must be obtained before any assessment is performed 2.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) 3.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 4.Male or female patients aged 18‐65 years 5.An Expanded Disability Status Scale (EDSS) score of 0‐5.5 inclusive 6.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 7.Na?ve to treatment with fingolimod. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age ra
Epistemonikos ID: 76e18584e361f1ce9dd630e1b537a691f0154538
First added on: Mar 31, 2022