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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Fingolimod
Interferon beta - 1a (IFN)
Glatiramer acetate (GA)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Relapsing Remitting Multiple Sclerosis (RRMS), Fingolimod, Disease Modifying Therapy (DMT), TSQM-9

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fingolimod

Standard Disease Modifying Therapy (DMT)

Arm Description

Participants received 0.5 mg orally once a day.

Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.

Outcomes

Primary Outcome Measures

Change in Patient-reported Treatment Satisfaction
The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.

Secondary Outcome Measures

Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Participants were monitored for adverse events, serious adverse events and death throughout the study.
Changes in Patient-reported Effectiveness, Side Effects and Convenience
TSQM v 1.4 domains for effectiveness, side effects and convenience were used to evaluate this outcome. The effectiveness domain for items 1 - 3 was scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the side effects domain, item 4 scored as 0(no) or 1(yes); item 5 scored as 1 (extremely bothersome) to 5 (not at all bothersome); and items 6 - 8 scored as 1 (a great deal) to 5 (not at all). For the convenience domain, items 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and item 11 scored as 1 (extremely inconvenient) to 7 (extremely convenient). For each domain, scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.
Change in Patient-reported Depression
The Beck Depression Inventory (BDI-I) scale was used to measure this outcome. The scale consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each item was scored from 0 - 3. If more than one score was provided for an item, the maximum score was considered the item score. The total score was calculated as the sum of all individual items and then compared to a key to determine the depression's severity. The standard key ranges were: 0 - 9 indicated minimal depression; 10 - 18 indicated mild depression; 19 - 29 indicated moderate depression and 30 - 63 indicated severe depression. Higher total scores indicate more severe depressive symptoms.
Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)
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). Each domain was scored by adding the individual items from the domain and transforming the resulting scores into a 0 to 100 scale with higher scores indicating better health status or functioning.

Full Information

First Posted
February 8, 2012
Last Updated
August 7, 2014
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01534182
Brief Title
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)
Acronym
EPOC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Relapsing Remitting Multiple Sclerosis (RRMS), Fingolimod, Disease Modifying Therapy (DMT), TSQM-9

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fingolimod
Arm Type
Experimental
Arm Description
Participants received 0.5 mg orally once a day.
Arm Title
Standard Disease Modifying Therapy (DMT)
Arm Type
Active Comparator
Arm Description
Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
Intervention Type
Drug
Intervention Name(s)
Fingolimod
Other Intervention Name(s)
Gilenya
Intervention Description
0.5 mg orally once a day
Intervention Type
Drug
Intervention Name(s)
Interferon beta - 1a (IFN)
Other Intervention Name(s)
Rebif
Intervention Description
44 mcg subcutaneously three times a week
Intervention Type
Drug
Intervention Name(s)
Glatiramer acetate (GA)
Other Intervention Name(s)
Copaxone
Intervention Description
20 mg subcutaneously once a day
Primary Outcome Measure Information:
Title
Change in Patient-reported Treatment Satisfaction
Description
The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Description
Participants were monitored for adverse events, serious adverse events and death throughout the study.
Time Frame
6 months
Title
Changes in Patient-reported Effectiveness, Side Effects and Convenience
Description
TSQM v 1.4 domains for effectiveness, side effects and convenience were used to evaluate this outcome. The effectiveness domain for items 1 - 3 was scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the side effects domain, item 4 scored as 0(no) or 1(yes); item 5 scored as 1 (extremely bothersome) to 5 (not at all bothersome); and items 6 - 8 scored as 1 (a great deal) to 5 (not at all). For the convenience domain, items 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and item 11 scored as 1 (extremely inconvenient) to 7 (extremely convenient). For each domain, scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.
Time Frame
Baseline, 6 months
Title
Change in Patient-reported Depression
Description
The Beck Depression Inventory (BDI-I) scale was used to measure this outcome. The scale consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each item was scored from 0 - 3. If more than one score was provided for an item, the maximum score was considered the item score. The total score was calculated as the sum of all individual items and then compared to a key to determine the depression's severity. The standard key ranges were: 0 - 9 indicated minimal depression; 10 - 18 indicated mild depression; 19 - 29 indicated moderate depression and 30 - 63 indicated severe depression. Higher total scores indicate more severe depressive symptoms.
Time Frame
Baseline, 6 months
Title
Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)
Description
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). Each domain was scored by adding the individual items from the domain and transforming the resulting scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Arkhangelsk
State/Province
Russia
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Belgorod
ZIP/Postal Code
308007
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Khanty-Mansiysk
ZIP/Postal Code
628012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kursk
ZIP/Postal Code
305007
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
N.Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhniy Novgorod
ZIP/Postal Code
603076
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410030
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St. Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Tumen
ZIP/Postal Code
625048
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Tver
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ufa
ZIP/Postal Code
450000
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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