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

NCT01498887 | Completed Phase 4 Results

• 2 other identifiers: CFTY720DES032011-003484-30
• Study Type: interventional
• Target: 347
• Locations: 2 countries
• Sites: 47

Brief 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

Keywords

Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Fingolimod; Early multiple sclerosis; Naive patients

Outcome Measures

Primary Outcomes (1)

• Annual Relapse Rate (ARR)

  ARR = 365 days \* number of relapses / total days taking the study medication.

  12 months

Secondary Outcomes (6)

• Time to First Relapse

  first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months

• Change From Baseline in Expanded Disability Status Scale (EDSS) Score

  baseline, 12 months

• Change From Baseline in Cerebral Volume

  baseline, 12 months

• Percentage of Participants With Mild, Moderate or Severe Relapse

  12 months

• Percentage of Relapse-free Participants

  12 months

Study Arms (2)

Naive or de novo participants

EXPERIMENTAL

Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Drug: Fingolimod (FTY720)

Previously treated with first-line DMTs participants

EXPERIMENTAL

Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Drug: Fingolimod (FTY720)

Interventions

Fingolimod (FTY720) DRUG

Hard gelatin capsules containing 0.5 mg of fingolimod.

Naive or de novo participants; Previously treated with first-line DMTs participants

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
• Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.
• Patients
• Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
• Previously treated with a first-line Disease Modifying Therapy

You may not qualify if:

• Patients who have received treatment with:
• Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (47)

Novartis Investigative Site

East Gosford, New South Wales, 2250, Australia

Location

Novartis Investigative Site

Kanwal, New South Wales, 2259, Australia

Location

Novartis Investigative Site

Liverpool, New South Wales, 2170, Australia

Location

Novartis Investigative Site

New Lambton Heights, New South Wales, 2305, Australia

Location

Novartis Investigative Site

Sydney, New South Wales, 2050, Australia

Location

Novartis Investigative Site

Auchenflower, Queensland, 4066, Australia

Location

Novartis Investigative Site

Adelaide, South Australia, Australia

Location

Novartis Investigative Site

Box Hill, Victoria, 3128, Australia

Location

Novartis Investigative Site

Fitzroy, Victoria, 3011, Australia

Location

Novartis Investigative Site

Melbourne, Victoria, 3000, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

Location

Novartis Investigative Site

Nedlands, Western Australia, 6009, Australia

Location

Novartis Investigative Site

Bedford Park, SA 5042, Australia

Location

Novartis Investigative Site

Brisbane Queensland, 4029, Australia

Location

Novartis Investigative Site

Geelong VIC, 3220, Australia

Location

Novartis Investigative Site

Ferrol, A Coruna, 15405, Spain

Location

Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

Location

Novartis Investigative Site

Granada, Andalusia, 18012, Spain

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

Location

Novartis Investigative Site

Seville, Andalusia, 41009, Spain

Location

Novartis Investigative Site

Seville, Andalusia, 41014, Spain

Location

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Novartis Investigative Site

Barakaldo, Basque Country, 48903, Spain

Location

Novartis Investigative Site

Bilbao, Basque Country, 48013, Spain

Location

Novartis Investigative Site

Santander, Cantabria, 39008, Spain

Location

Novartis Investigative Site

León, Castille and León, 24080, Spain

Location

Novartis Investigative Site

Valladolid, Castille and León, 47011, Spain

Location

Novartis Investigative Site

Albacete, Castille-La Mancha, 02006, Spain

Location

Novartis Investigative Site

Badalona, Catalonia, 08916, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Tarragona, Catalonia, 43007, Spain

Location

Novartis Investigative Site

A Coruña, Galicia, 15006, Spain

Location

Novartis Investigative Site

Las Palmas de Gran Canaria, Las Palmas de G.C, 35010, Spain

Location

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Novartis Investigative Site

Oviedo, Principality of Asturias, 33006, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46010, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46017, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Las Palmas de Gran Canaria, 35016, Spain

Location

Novartis Investigative Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

Madrid, 28007, Spain

Location

Novartis Investigative Site

Madrid, 28034, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Santa Cruz de Tenerife, 38009, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 26, 2011
• Study Start: December 24, 2011
• Primary Completion: December 26, 2015
• Study Completion: December 26, 2015
• Last Updated: January 25, 2019
• Results First Posted: January 25, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (15); ES (32)