Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01281657
First received: January 19, 2011
Last updated: September 5, 2012
Last verified: September 2012

January 19, 2011
September 5, 2012
February 2011
July 2012   (final data collection date for primary outcome measure)
Long-term safety data in patients with relapsing forms of multiple sclerosis who have participated in clinical trials with fingolimod and who are now taking prescribed fingolimod under the conditions of routine medical practice [ Time Frame: Throughout the entirety of the study up to a maximum of 8 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01281657 on ClinicalTrials.gov Archive Site
Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability [ Time Frame: Throughout the entirety of the study up to a maximum of 8 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program
A Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development Program

The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with relapsing forms of MS who have participated in previous fingolimod trials and now taking commercially available fingolimod as part of routine medical care

Multiple Sclerosis
Drug: fingolimod
Prescribed fingolimod 0.5 mg/day
Intervention: Drug: fingolimod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are prescribed fingolimod as part of their routine medical care
  • Patients who have participated in a prior fingolimod clinical trials

Exclusion Criteria:

  • Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label
  • Any patient who has prematurely discontinued from the previous fingolimod trial

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01281657
CFTY720D2399E1
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP