Clinical trial NCT01623596
Conditions: Relapsing Remitting Multiple Sclerosis
Sponsor: Novartis Pharmaceuticals
Start date: 2012-06-08; Completion date: 2015-07-13
Enrollment: 881 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved disease modifying therapy. Patients will be be treatment naive or have only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) . 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.

Detailed description:
852 Patients with 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) . 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.

Arms: arm 1: None arm 2: 2 classes - Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex) or glatiramer acetate (Copaxone)
Interventions: intervention 1: Fingolimod intervention 2: Disease Modifying therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: