NCT01621269

Brief Summary

Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_4 multiple-sclerosis

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 20, 2017

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

April 24, 2012

Last Update Submit

April 19, 2017

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisMSFingolimodGilenyaNeutralizing AntibodiesNAb

Outcome Measures

Primary Outcomes (1)

  • Number of patients with active MRI lesions

    number of patients with neutralizing antibodies against IFN-ß with reduction of number of combined unique active lesions on brain MRI (CUAL) defined as those lesions that are new or recurrent or enlarging on T2-weighted scans or those that are new and taking Gd-enhancement on T1-weighted scans, avoiding double counting

    12 months

Secondary Outcomes (1)

  • Number of patients with adverse events

    12 months

Study Arms (1)

Fingolimod

EXPERIMENTAL
Drug: Fingolimod

Interventions

FingolimodDRUG
Fingolimod

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects aged 18-65 years
  • Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
  • Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
  • Interferon-beta (IFN-β) treatment for at least 18 months.
  • Positive IFN-NAb titer at screening or within 6 months prior to screening
  • Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months)

You may not qualify if:

  • patients with previous or current disease of immune system
  • active infections
  • cardiovascular risk patients
  • Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

April 24, 2012

First Posted

June 18, 2012

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 20, 2017

Record last verified: 2014-09