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Medical information request
Medical information request

PARADIGMS

Study design

Double-blind, randomized, active-controlled two-year study vs interferon beta-1a in pediatric patients with RRMS**

Paradigms-Study-Design-v1
**Fingolimod has not been studied in children less than 10 years of age

A double-blind, randomized, clinical trial that compared the efficacy and safety of fingolimod 0.25 mg or 0.5 mg (dose selected based on body weight) once daily to intramuscular (IM) interferon beta-1a 30 mcg in 215 pediatric patients 10 to less than 18 years of age with RRMS
Patient baseline characteristics:
              1. RRMS diagnosis based on the revised consensus definition for pediatric MS, which includes the 2010 McDonald criteria
              2. EDSS score: 0-5.5. Median score at baseline was 1.5
              3. Previously treated or treatment-naïve patients with at least 1 relapse in the past year, or 2 relapses in the previous 2 years, or evidence of at least 1 Gd+ 
                T1 lesion on  MRI in 6 months before randomization
              4. No evidence of progressive MS or other immune system diseases or other demyelinating disorders, acute disseminated encephalomyelitis,
                or neuromyelitis optica
Primary end point: The annualized relapse rate, defined as the average number of confirmed relapses per year over the period of active treatment
Key secondary end point: The annualized rate of new or newly enlarged lesions detected on T2-weighted MRI as compared with baseline
Other secondary end points:
              1. Effect on Gd+ T1 lesions
              2. Safety and tolerability
Patients were required to remain at the site for at least 6 hours after receiving the first dose of study drug (ie, first-dose monitoring on Day 1). First-dose observation included monitoring of vital signs (heart rate and blood pressure), for potential signs of bradycardia, and electrocardiography
Prior therapy with interferon-beta, dimethyl fumarate, or glatiramer acetate up to the time of randomization was permitted
Baseline assessments and neurologic evaluations were performed at screening. Additional neurological evaluations were completed every 3 months and at the time of suspected relapses
MRI evaluations were performed at screening, and every 6 months throughout the study
**Fingolimod has not been studied in children less than 10 years of age

AE profile of fingolimod versus interferon: PARADIGMS double-blind treatment phase1

Paradigms Table 1-v

AE profile of fingolimod over 4.7 years: PARADIGMS extension study (Interim analysis)2

Paradigms Table 2-new table to be added-v_0
NOTE: Due to the interim nature of the analysis the data shown is subject to changes until the final data base lock.
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Abbreviations
AE, adverse event; ARR; annualized relapse rate; EDSS, Expanded Disability Status Scale; Gd+, gadolinium-enhancing; IFNβ-1a IM, interferon beta-1a intramuscular; MRI, magnetic resonance imaging; MS, multiple sclerosis; RRMS, relapsing-remitting multiple sclerosis; URTI, upper respiratory tract infection; qd, once-daily; qw, once-weekly
References
1. Chitnis T, et al. N Engl J Med. 2018;379:1017–1027.
2. Data on file, interim analysis, cutoff date 31-Jul-2020, Novartis Pharma AG.
* 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.