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

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ClinicalTrials.gov Identifier: NCT01317004
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : June 22, 2015
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsing Remitting Multiple Sclerosis
Interventions Drug: Fingolimod
Drug: Standard MS DMT
Enrollment 61
Recruitment Details Actual enrollment = 61 because 65 participants were randomized to the study, but only 61 participants received at least one dose of study medication. As such, the participant flow captures the 65 participants randomized and the 61 participants who received drug as the safety set.
Pre-assignment Details  
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Hide Arm/Group Description Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period. 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.
Period Title: Overall Study
Started 51 14
Safety Set 50 11
Completed 47 5
Not Completed 4 9
Reason Not Completed
Withdrawal by Subject             1             4
Protocol Violation             0             2
Adverse Event             3             3
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT) Total
Hide Arm/Group Description Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period. 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. Total of all reporting groups
Overall Number of Baseline Participants 50 11 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 11 participants 61 participants
37.96  (8.69) 35.82  (7.22) 37.57  (8.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 11 participants 61 participants
Female
32
  64.0%
8
  72.7%
40
  65.6%
Male
18
  36.0%
3
  27.3%
21
  34.4%
1.Primary Outcome
Title Change From Baseline in Patient-reported Treatment Satisfaction
Hide Description 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.
Time Frame baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Hide Arm/Group Description:
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
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.
Overall Number of Participants Analyzed 46 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
19.57  (21.00) 5.83  (16.47)
2.Secondary Outcome
Title Change From Baseline in Patient-reported Activities of Daily Living (ADL)
Hide Description 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.
Time Frame baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Hide Arm/Group Description:
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
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.
Overall Number of Participants Analyzed 49 11
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.19  (2.75) 0.15  (1.72)
3.Secondary Outcome
Title Change From Baseline in Patient-reported Fatigue
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Hide Arm/Group Description:
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
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.
Overall Number of Participants Analyzed 48 11
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.18  (1.46) -0.32  (1.21)
4.Secondary Outcome
Title Change From Baseline in Patient–Reported Effectiveness and Convenience
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Hide Arm/Group Description:
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
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.
Overall Number of Participants Analyzed 46 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
Effectiveness 13.53  (28.39) -1.67  (32.40)
Convenience 24.64  (18.28) 12.78  (25.26)
5.Secondary Outcome
Title Change From Baseline in Patient-reported Depression
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Hide Arm/Group Description:
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
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.
Overall Number of Participants Analyzed 48 11
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.15  (3.59) -0.12  (3.06)
6.Secondary Outcome
Title Change From Baseline in Patient-reported Health Related Quality of Life (QOL)
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Hide Arm/Group Description:
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
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.
Overall Number of Participants Analyzed 45 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
Physical functioning (n=41,9) 1.71  (23.07) -1.11  (20.73)
Role limitations due to physical health (n=42,9) 7.14  (37.97) 5.56  (27.32)
Pain (n=45,9) 6.56  (24.32) 14.44  (15.25)
General health (n=44,8) 4.52  (19.43) 6.25  (14.08)
Energy/fatigue (n=43,9) 2.33  (18.81) 6.48  (33.24)
Social functioning (n=45,9) 7.78  (24.90) 6.94  (25.85)
Role limitations d/t emotional problems (n=45,9) 7.04  (41.82) 3.70  (38.89)
Emotional well-being (n=43,9) 2.51  (16.88) 4.89  (28.13)
PCS (n=40,8) 4.52  (18.05) 7.83  (15.86)
MCS (n=40,8) 5.88  (18.21) 7.28  (24.05)
7.Secondary Outcome
Title Physician-reported Clinical Global Impression of Improvement (CGI-I)
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety set, who had values at month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Hide Arm/Group Description:
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
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.
Overall Number of Participants Analyzed 44 9
Measure Type: Number
Unit of Measure: Percentage of participants
Much improved 13.64 11.11
Minimally improved 36.36 11.11
No change 47.73 66.67
Minimally worse 2.27 11.11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Hide Arm/Group Description Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period. 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.
All-Cause Mortality
Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/50 (8.00%)   1/11 (9.09%) 
Blood and lymphatic system disorders     
Lymphopenia  1  2/50 (4.00%)  0/11 (0.00%) 
General disorders     
Drug ineffective  1  1/50 (2.00%)  0/11 (0.00%) 
Investigations     
Human papilloma virus test positive  1  0/50 (0.00%)  1/11 (9.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Meningioma  1  1/50 (2.00%)  0/11 (0.00%) 
Nervous system disorders     
Multiple sclerosis relapse  1  1/50 (2.00%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
Affected / at Risk (%) Affected / at Risk (%)
Total   13/50 (26.00%)   7/11 (63.64%) 
Blood and lymphatic system disorders     
Lymphopenia  1  8/50 (16.00%)  0/11 (0.00%) 
Endocrine disorders     
Hyperthyroidism  1  0/50 (0.00%)  1/11 (9.09%) 
Eye disorders     
Vision blurred  1  0/50 (0.00%)  1/11 (9.09%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/50 (0.00%)  1/11 (9.09%) 
Nausea  1  0/50 (0.00%)  1/11 (9.09%) 
Vomiting  1  0/50 (0.00%)  1/11 (9.09%) 
General disorders     
Adverse drug reaction  1  0/50 (0.00%)  1/11 (9.09%) 
Influenza like illness  1  1/50 (2.00%)  1/11 (9.09%) 
Injection site reaction  1  0/50 (0.00%)  1/11 (9.09%) 
Hepatobiliary disorders     
Hypertransaminasaemia  1  1/50 (2.00%)  1/11 (9.09%) 
Investigations     
Transaminases increased  1  4/50 (8.00%)  0/11 (0.00%) 
Weight decreased  1  0/50 (0.00%)  1/11 (9.09%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/50 (0.00%)  1/11 (9.09%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/50 (0.00%)  1/11 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01317004     History of Changes
Other Study ID Numbers: CFTY720DIT02
2010-024017-31 ( EudraCT Number )
First Submitted: March 15, 2011
First Posted: March 16, 2011
Results First Submitted: May 29, 2015
Results First Posted: June 22, 2015
Last Update Posted: June 22, 2015