NCT01498887

Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy

A Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 347 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who had previously received first-line DMTs.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fingolimod (FTY720)	Hard gelatin capsules containing 0.5 mg of fingolimod.

Timeline

• Start date: 2011-12-24
• Primary completion: 2015-12-26
• Completion: 2015-12-26
• First posted: 2011-12-26
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

47 sites across 2 countries: Australia, Spain