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FREEDOMS

Study design

Double-blind, randomized, placebo-controlled two-year Phase 3 study in adults with RRMS

Freedom - Study Design-v
A 2-year, randomized, double-blind, placebo-controlled phase 3 study of 1,272 adults with RRMS
Patients were randomly assigned to receive a once-daily dose of fingolimod 0.5 mg (n=425) or 1.25 mg (n=429) or matching placebo once daily (n=418) for 2 years
Patient baseline characteristics:
              1. Between 18 and 55 years of age
              2. A diagnosis of RRMS with at least 1 documented relapse during the previous year or at least 2 documented relapses  during the previous 2 years
              3. A score of 0.0 to 5.5 on the EDSS. Median score at baseline was 2.0
Primary end point: ARR
Key secondary end point: time to 3-month confirmed disability progression as measured by at least a 1-point increase from baseline in EDSS (0.5-point increase for patients with baseline EDSS of 5.5) sustained for 3 months**
Additional secondary end points included number of Gd+ T1 lesions and number of new or newly enlarged lesions on T2-weighted MRI scans
**The analysis of a key secondary end point includes the same intent-to-treat population as the primary end point(s), as well as logistic regression adjusting for certain baseline characteristics of the sample


AE profile of fingolimod versus placebo over 2 years: FREEDOMS and FREEDOMS II studies1

FREEDOMS table 1

AE profile of fingolimod over 4 years: FREEDOMS Extension study2

freedoms Table 2-v
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Abbreviations
ARR, annualized relapse rate; AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; EDSS, Expanded Disability Status Scale; Gd+, gadolinium enhanced; GGT, gamma-glutamyl transferase; MRI, magnetic resonance imaging; RRMS, relapsing-remitting multiple sclerosis; qd, once-daily
References
1. Gilenya US Prescribing Information. Accessed 10-Feb-2021. https://www.novartis.us/sites/www.novartis.us/files/gilenya.pdf
2. Kappos L, et al. Neurology. 2015;84(15):1582-1591. 
* Indication wording varies in different countries. The current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of fingolimod in the individual country.