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Patients With RRMS:Candidates for MS Therapy Change (EPOC)

This study is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01317004
First received: March 15, 2011
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
 Drug: Fingoliomod
Drug: Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
 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 Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Primary objective is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the TSQM-9. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate safety and tolerability immediately after a change in DMT and during 6 months of treatment with fingolimod vs. DMT standard of care in patients who have been previously treated for RRMS. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Evaluate the change in patient-reported Activities of Daily Living (ADL) with fingolimod vs. DMT standard of care, using the Multiple Sclerosis Activities Scale (PRIMUS-Activities), in patients who have been previously treated for RRMS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluate the change in patient-reported fatigue with fingolimod vs. DMT standard of care, using the Fatigue Severity Scale (FSS), in patients who have been previously treated for RRMS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluate changes in patient-reported effectiveness and convenience subscales with fingolimod vs. DMT standard of care, using the TSQM-9, in patients who have been previously treated for RRMS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluate the change in patient-reported depression with fingolimod vs. DMT standard of care, using the Beck Depression Inventory Fast Screen (BDI-FS), in patients who have been previously treated for RRMS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod Drug: Fingoliomod
Active Comparator: Standard therapy Drug: Interferon beta 1a or interferon beta 1b or Glatiramer Acetate

  Eligibility

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

Inclusion Criteria:

  • Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
  • Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
  • An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.
  • Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
  • Naïve to treatment with fingolimod.

Exclusion Criteria:

  • A manifestation of MS other than those defined in the inclusion criteria.
  • A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
  • Diagnosis of macular edema during Screening Phase.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317004

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Italy
Novartis Investigative Site Recruiting
Ancona, AN, Italy, 60126
Novartis Investigative Site Recruiting
L'Aquila, AQ, Italy, 67100
Novartis Investigative Site Recruiting
Barletta, BA, Italy, 70051
Novartis Investigative Site Recruiting
Biella, BI, Italy, 13900
Novartis Investigative Site Withdrawn
Bologna, BO, Italy, 40139
Novartis Investigative Site Withdrawn
Chiari, BS, Italy, 25032
Novartis Investigative Site Recruiting
Bolzano, BZ, Italy, 39100
Novartis Investigative Site Withdrawn
Merano, BZ, Italy
Novartis Investigative Site Withdrawn
Cagliari, CA, Italy, 09134
Novartis Investigative Site Recruiting
Caltanissetta, CL, Italy, 93100
Novartis Investigative Site Recruiting
Cuneo, CN, Italy, 12100
Novartis Investigative Site Recruiting
Como, CO, Italy, 22100
Novartis Investigative Site Recruiting
Catania, CT, Italy, 95122
Novartis Investigative Site Recruiting
Foggia, FG, Italy, 71100
Novartis Investigative Site Recruiting
Empoli, FI, Italy, 50053
Novartis Investigative Site Withdrawn
Genova, GE, Italy, 16153
Novartis Investigative Site Recruiting
Imperia, IM, Italy, 18100
Novartis Investigative Site Recruiting
Lecce, LE, Italy, 73100
Novartis Investigative Site Recruiting
Livorno, LI, Italy, 57124
Novartis Investigative Site Recruiting
Monza, MB, Italy, 20900
Novartis Investigative Site Recruiting
Messina, ME, Italy, 98125
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Withdrawn
Milano, MI, Italy, 20100
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20122
Novartis Investigative Site Recruiting
San Donato Milanese, MI, Italy, 20097
Novartis Investigative Site Recruiting
Modena, MO, Italy, 41100
Novartis Investigative Site Recruiting
Palermo, PA, Italy, 90129
Novartis Investigative Site Recruiting
Palermo, PA, Italy, 90146
Novartis Investigative Site Recruiting
Perugia, PG, Italy, 06129
Novartis Investigative Site Recruiting
Pisa, PI, Italy, 56126
Novartis Investigative Site Withdrawn
Fidenza, PR, Italy, 43036
Novartis Investigative Site Recruiting
Reggio Calabria, RC, Italy, 89100
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00133
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00186
Novartis Investigative Site Withdrawn
Sassari, SS, Italy, 07100
Novartis Investigative Site Recruiting
Trieste, TS, Italy, 34149
Novartis Investigative Site Recruiting
Legnago, VR, Italy, 37045
Novartis Investigative Site Recruiting
Verona, VR, Italy, 37126
Novartis Investigative Site Withdrawn
Napoli, Italy, 80132
Novartis Investigative Site Recruiting
Novara, Italy, 28100
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Renato Turrini, MD Novartis Farma S.p.A.
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01317004     History of Changes
Other Study ID Numbers: CFTY720DIT02, 2010-024017-31
Study First Received: March 15, 2011
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration
Italy: Agenzia italiana del farmaco (AIFA)

Keywords provided by Novartis:
Multiple sclerosis
Fingolimod
Disease Modifying Therapy
TSQM-9

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta-1b
 Interferon beta 1a
Copolymer 1
Fingolimod
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 21, 2013