Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change (EPOC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01317004
First received: March 15, 2011
Last updated: June 18, 2015
Last verified: June 2015
  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: Fingolimod
Drug: Standard MS DMT
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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Patient-reported Treatment Satisfaction [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.


Secondary Outcome Measures:
  • Change From Baseline in Patient-reported Activities of Daily Living (ADL) [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.

  • Change From Baseline in Patient-reported Fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.

  • Change From Baseline in Patient-Reported Effectiveness and Convenience [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.

  • Change From Baseline in Patient-reported Depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness. The BDI-FS score was calculated summing the 7 items of the questionnaire. Each item ranged from 0 (not present) to 3 (severe). The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression). A negative change from baseline indicates improvement.

  • Change From Baseline in Patient-reported Health Related Quality of Life (QOL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.

  • Physician-reported Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. A lower score and a negative change from baseline indicate improvement.


Enrollment: 61
Study Start Date: May 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
Drug: Fingolimod
0.5 mg/day oral capsule
Other Name: GILENYA™
Active Comparator: Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
Drug: Standard MS DMT
Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
Other Names:
  • Avonex®,
  • Copaxone®,
  • Rebif®,
  • Betaferon®,
  • Extavia®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Novartis Investigative Site
Ancona, AN, Italy, 60126
Novartis Investigative Site
Ponderano, BI, Italy, 13900
Novartis Investigative Site
Caltanissetta, CL, Italy, 93100
Novartis Investigative Site
Cuneo, CN, Italy, 12100
Novartis Investigative Site
Como, CO, Italy, 22100
Novartis Investigative Site
Catania, CT, Italy, 95122
Novartis Investigative Site
Foggia, FG, Italy, 71100
Novartis Investigative Site
Castelfiorentino, FI, Italy, 50051
Novartis Investigative Site
Milano, MI, Italy, 20122
Novartis Investigative Site
Milano, MI, Italy, 20133
Novartis Investigative Site
San Donato Milanese, MI, Italy, 20097
Novartis Investigative Site
Modena, MO, Italy, 41100
Novartis Investigative Site
Palermo, PA, Italy, 90129
Novartis Investigative Site
Palermo, PA, Italy, 90146
Novartis Investigative Site
Pisa, PI, Italy, 56126
Novartis Investigative Site
Legnago, VR, Italy, 37045
Novartis Investigative Site
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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01317004     History of Changes
Other Study ID Numbers: CFTY720DIT02  2010-024017-31 
Study First Received: March 15, 2011
Results First Received: May 29, 2015
Last Updated: June 18, 2015
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
Interferon beta-1a
Fingolimod Hydrochloride
Interferon beta-1b
Glatiramer Acetate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Adjuvants, Immunologic
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 22, 2016