Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis. (PREFERMS)
A 12 month study where 1000 patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved disease modifying therapy. Patients will be in early stages of the disease and be treatment naive or have only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) for no more than 5 years total exposure. Patients will be able to switch to different treatment for safety, efficacy, tolerability or convenience during the study.
Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on treatment. Secondary objectives are to compare reasons for discontinuation, adverse events, cognitive impairment, medication satisfaction and change in brain volume measured by MRI.
Relapsing Remitting Multiple Sclerosis
Drug: Disease Modifying therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults Who Are in Early Stages of Treatment for Relapsing Remitting Multiple Sclerosis (PREFERMS)|
- Retention on treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]Retention on treatment over a 12 month period.
- Reasons for Discontinuation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]To compare reasons for discontinuation in patients treated with fingolimod vs. DMT over 12 months of treatment
- Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Compare the occurrence and persistence of drug-related adverse events over 12 months of treatment
- Cognitive impairment [ Time Frame: 12 months ] [ Designated as safety issue: No ]Compare cognitive impairment measured by Symbol Digit Modalities Test scores.
- Percent change in brain volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]Compare percent change in brain volume in patients treated with fingolimod vs.DMTs as measured by MRI
- Treatment satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]Compare medication satisfaction as measured by the Medication Satisfaction Questionnaire
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
|Experimental: Fingolimod||Drug: Fingolimod|
Active Comparator: Disease Modifying Therapy
2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
|Drug: Disease Modifying therapy|
1000 Patients in early stages of treatment for relapsing remitting MS will be randomized 1:1 to fingolimod or approved first line DMTs. Patients must be either treatment naive or have received treatment with only one class of treatment (interferon beta preparation or glatiramer acetate) for no more than five years total exposure. Patients previously treated with DMT and randomized to the DMT arm may not remain on the same treatment for the study and will have to switch to a different class (i.e., previously treated with glatiramer acetate will switch to interferon beta preparaption, previously treated with interferon beta preparation will swtich to glatiramer acetate).
Entry criteria at screening include but are not limited to, age 18-65, diagnosis with RRMS, EDSS < or equal to 6, not pregnant or planning pregnancy and women of childbearing potential willing to use contraception throughout the study.
Exclusion criteria include but are not limited to - prior exposure to fingolimod, history of malignancy within 5 years, other than RRMS types of MS, other diseases of the immune system, active macular edema, systemic bacterial, viral or fungal infections, patients without vaccine against varicella zoster, receipt of live or attentuated vaccines within a month of screening, history of various cardiac conditions, presence of certain ECG abnormalities, resting heart rate < 45 bpm, symptomatic bradycardia, recurrent syncope, severe untreated sleep apnea, severe pulmonary conditions, various hepatic conditions, certain neurologic disorders, pregnancy.
Patients may switch treatment before 3 months for safety reasons only, after 3 months for safety, efficacy, tolerability or convenience. Treatment switch during the study may be to any of study approved treatments irrespective of prior treatment.
Patients randomized to fingolimod will need to have 6 hours of observation for signs and symptoms of bradycardia following administration of the first dose. Extended observation or overnight observation may be necessary under certain circumstances. Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on treatment. Secondary objectives are to compare reasons for discontinuation, adverse events, cognitive impairment, medication satisfaction and change in brain volume measured by MRI. Exploratory objectives include annualized relapse rate, OCT, MRI evaluations, biomarkers and patient reported outcome measures.
|Contact: Novartis Pharmaceuticals||1-888-669-6682|
|Contact: Novartis Pharmaceuticals|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|