Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01534182
First received: February 8, 2012
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: Fingolimod 0.5 mg/day per os
Drug: Interferon β- 1a
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) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in patient-reported treatment satisfaction [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

    The Treatment Satisfaction Questionnaire for Medication (TSQM) v 1.4 will be used to evaluate change in Global Satisfaction following change in therapy .

    Responses to items are summed and transformed so that higher scores indicate greater satisfaction. Specifically, TSQM v 1.4 scale scores are computed by adding the items loading on each domain. The lowest possible score is subtracted from the composite score and divided by the greatest possible score range. This provides a transformed score between 0 and 1 that is then multiplied by 100.



Secondary Outcome Measures:
  • Evaluation of Patient Reported Outcomes in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC) [ Time Frame: Experiencing at 6 Months ] [ Designated as safety issue: Yes ]
    The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g., vital signs, ophthalmic and cardiovascular findings) will be summarized, as appropriate.

  • Changes in patient-reported effectiveness, side effects and convenience subscales with fingolimod vs. DMT standard of care, using the TSQM v1.4, in patients who have been previously treated for RRMS [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    TSQM v 1.4 subscales for effectiveness, and convenience will be included. The analysis of variable will be similar to the analysis of the primary variable

  • Change in patient-reported depression with fingolimod vs. DMT standard of care, using the Beck Depression Inventory (BDI-I), in patients who have been previously treated for RRMS [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

    As BDI-I is brief and not confounded with neurological symptoms, it is recommended for depression evaluation in patients with multiple sclerosis.

    If suicidal ideation is detected by the BDI-I, evaluation and appropriate treatment must be initiated immediately according to the clinical judgment of the investigator or treating physician, and the site must notify the monitor. The event will be reported as an SAE and data will be captured on an electronic Case Report Form (eCRF) identifying the serious adverse event (SAE). The BDI-I will be completed at screening and 3 and 6 months.


  • Change in patient-reported health-related quality-of-life with fingolimod vs. DMT standard of care, using the Short Form Health Survey v2 acute (SF-36 v2 acute), in patients who have been previously treated for RRMS [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    The SF-36 is a health-related quality of life instrument used in numerous disease states, including MS (Brazier et al 1992). It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-36v2 acute will be completed at screening and month 6.


Enrollment: 313
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Fingolimod 0.5 mg/day per os
Experimental: 2 Drug: Interferon β- 1a
Interferon β- 1a 44 mcg subcutaneously three times a week or glatiramer acetate subcutaneously, 20 mg a day

  Eligibility

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

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
  • Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
  • Male or female patients aged 18-70 years.
  • An Expanded Disability Status Scale (EDSS) score of 0-6 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.
  • Diagnosis of macular edema during Screening Phase.
  • Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
  • Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
  • Patients who have received total lymphoid irradiation or bone marrow transplantation.
  • History of selected immune system treatments and/or medications.
  • Any medically unstable condition, as assessed by the investigator.
  • Selected cardiovascular, or hepatic conditions
  • Selected abnormal laboratory values.
  • Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
  • Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
  • History of hypersensitivity to the study drug or to drugs of similar chemical classes.
  • Pregnant or nursing (lactating) women.

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: NCT01534182

Locations
Russian Federation
Novartis Investigative Site
Arkhangelsk, Russia, Russian Federation, 163045
Novartis Investigative Site
Barnaul, Russian Federation, 656024
Novartis Investigative Site
Belgorod, Russian Federation, 308007
Novartis Investigative Site
Kazan, Russian Federation, 420021
Novartis Investigative Site
Kemerovo, Russian Federation, 650066
Novartis Investigative Site
Khanty-Mantiysk, Russian Federation, 628012
Novartis Investigative Site
Kirov, Russian Federation, 610014
Novartis Investigative Site
Krasnodar, Russian Federation, 350086
Novartis Investigative Site
Kursk, Russian Federation, 305007
Novartis Investigative Site
Moscow, Russian Federation, 127018
Novartis Investigative Site
Moscow, Russian Federation, 119992
Novartis Investigative Site
N.Novgorod, Russian Federation, 603126
Novartis Investigative Site
Nizhniy Novgorod, Russian Federation, 603076
Novartis Investigative Site
Nizhny Novgorod, Russian Federation, 603155
Novartis Investigative Site
Novosibirsk, Russian Federation, 630087
Novartis Investigative Site
Perm, Russian Federation, 614097
Novartis Investigative Site
Saransk, Russian Federation, 430032
Novartis Investigative Site
Saratov, Russian Federation, 410030
Novartis Investigative Site
Smolensk, Russian Federation, 214019
Novartis Investigative Site
St. Petersburg, Russian Federation, 197376
Novartis Investigative Site
Tomsk, Russian Federation, 634050
Novartis Investigative Site
Tumen, Russian Federation, 625000
Novartis Investigative Site
Tver, Russian Federation, 170036
Novartis Investigative Site
Ufa, Russian Federation, 450071
Novartis Investigative Site
Ulyanovsk, Russian Federation, 432063
Novartis Investigative Site
Yaroslavl, Russian Federation, 150030
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01534182     History of Changes
Other Study ID Numbers: CFTY720DRU01
Study First Received: February 8, 2012
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation

Keywords provided by Novartis:
Relapsing Remitting Multiple Sclerosis (RRMS)
Fingolimod
Disease Modifying Therapy (DMT)
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
Interferons
Fingolimod
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014