A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis - Full Text View

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT01216072

Purpose

The purpose of this study is to evaluate patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patient with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

Condition	Intervention	Phase
Relapsing Forms of Multiple Sclerosis	Drug: Fingolimod Drug: Avonex®, Copaxone®, Rebif®, Betaseron® or Extavia®	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Glatiramer Interferon beta-1b Interferon beta-1a Glatiramer acetate Fingolimod Fingolimod hydrochloride Rebif

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Treatment Satisfaction Questionnaire for Medication [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability immediately after a change in Disease Modifying Therapy (DMT) during 6 months of treatment with fingolimod vs. DMT standard of care [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
Change in patient-reported Activities of Daily Living (ADL) using the Multiple Sclerosis Activities Scale (PRIMUS-Activities). [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in patient-reported fatigue using the Fatigue Severity Scale (FSS) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Changes in patient-reported effectiveness, side effects and convenience subscales using the TSQM v1.4 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in patient-reported depression using the Beck Depression Inventory (BDI-II) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Enrollment:	1053
Study Start Date:	August 2010
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fingolimod 0.5 mg/day oral capsule	Drug: Fingolimod
Active Comparator: Multiple Sclerosis Disease Modifying Treatments (MS DMTs)	Drug: Avonex®, Copaxone®, Rebif®, Betaseron® or Extavia®

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Relapsing Remitting MS
EDSS 0-5.5
Treatment with MS DMT for 6 months
Fingolimod naive

Exclusion Criteria:

Immune system diseases other than MS
Macular edema
History of selected prior infections and criteria for immunizations
History of selected immune system treatments and/or medications
Selected cardiovascular, pulmonary, or hepatic conditions
Selected abnormal laboratory values
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216072

Show 181 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Click here for more information about this study: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01216072 History of Changes
Other Study ID Numbers:	CFTY720DUS01
Study First Received:	September 7, 2010
Last Updated:	November 22, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Novartis:

Relapsing Forms of Multiple Sclerosis
Disease Modifying Therapy
fingolimod
Patient Reported Outcomes

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

Interferon beta-1b
Copolymer 1
Fingolimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 23, 2012