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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)

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ClinicalTrials.gov Identifier: NCT01534182
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : August 8, 2014
Last Update Posted : August 8, 2014
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: Interferon beta - 1a (IFN)
Drug: Glatiramer acetate (GA)
Enrollment 298
Recruitment Details Participants at screening received standard DMT with either interferon beta-1a or glatiramer acetate from day -30 to day -1.
Pre-assignment Details Eligible participants were then randomized in a 3:1 ratio to fingolimod or a standard DMT. For participants who were randomized to the standard DMT group, those who received IFN during screening were switched to GA at randomization and those who received GA during screening were switched to IFN at randomization.
Arm/Group Title Fingolimod Standard Disease Modifying Therapy (DMT)
Hide Arm/Group 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.
Period Title: Overall Study
Started 230 68
Safety Set 230 64
Full Analysis Set 229 62
Completed 218 58
Not Completed 12 10
Reason Not Completed
Administrative problems             1             0
Withdrawal by Subject             4             7
Adverse Event             7             3
Arm/Group Title Fingolimod Standard Disease Modifying Therapy (DMT) Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 230 68 298
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 230 participants 68 participants 298 participants
35.4  (9.9) 36.4  (9.3) 35.6  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 230 participants 68 participants 298 participants
Female
162
  70.4%
50
  73.5%
212
  71.1%
Male
68
  29.6%
18
  26.5%
86
  28.9%
1.Primary Outcome
Title Change in Patient-reported Treatment Satisfaction
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): This set included all randomized participants who had taken at least one dose of study medication and had at least one post-baseline assessment of the TSQM. The last observation carried forward (LOCF) method was applied.
Arm/Group Title Fingolimod Standard Disease Modifying Therapy (DMT)
Hide Arm/Group 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.
Overall Number of Participants Analyzed 229 62
Mean (Standard Deviation)
Unit of Measure: scores on a scale
22.69  (28.12) 13.92  (30.63)
2.Secondary Outcome
Title Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Hide Description Participants were monitored for adverse events, serious adverse events and death throughout the study.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: This set included all randomized participants who received at least one dose of study medication.
Arm/Group Title Fingolimod Standard Disease Modifying Therapy (DMT)
Hide Arm/Group 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.
Overall Number of Participants Analyzed 230 64
Measure Type: Number
Unit of Measure: Participants
Adverse events (serious and non-serious) 73 26
Serious adverse events 2 0
Deaths 0 0
3.Secondary Outcome
Title Changes in Patient-reported Effectiveness, Side Effects and Convenience
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: The LOCF method was applied.
Arm/Group Title Fingolimod Standard Disease Modifying Therapy (DMT)
Hide Arm/Group 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.
Overall Number of Participants Analyzed 229 62
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Effectiveness 21.57  (24.01) 11.56  (20.70)
Side effects 26.75  (35.83) 13.07  (40.19)
Convenience 25.38  (20.72) 10.57  (20.93)
4.Secondary Outcome
Title Change in Patient-reported Depression
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS: The LOCF method was applied.
Arm/Group Title Fingolimod Standard Disease Modifying Therapy (DMT)
Hide Arm/Group 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.
Overall Number of Participants Analyzed 229 62
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.88  (6.80) -1.86  (8.04)
5.Secondary Outcome
Title Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set were considered for this analysis. However, for a given time frame, participants analyzed had both baseline and 6 month asssessment values.
Arm/Group Title Fingolimod Standard Disease Modifying Therapy (DMT)
Hide Arm/Group 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.
Overall Number of Participants Analyzed 229 62
Mean (Standard Deviation)
Unit of Measure: scores on scale
Physical functioning (n=225,61) 3.62  (16.23) 1.39  (14.23)
Role limitations due to physical health (n=226,61) 6.50  (21.99) 4.30  (27.52)
Bodily pain (n=225,61) 5.24  (23.79) 0.93  (22.95)
General health (n=226,61) 4.28  (17.72) 4.43  (22.57)
Vitality (n=226,61) 7.72  (18.61) 1.95  (21.97)
Social functioning (n=226,61) 5.59  (23.36) 1.64  (23.77)
Role limit. due to emotional problems (n=224,61) 7.18  (25.98) 5.33  (27.00)
Mental health (n=226,61) 5.60  (18.55) 2.79  (22.09)
Physical component summary (n=222,61) 1.51  (5.69) 0.68  (6.57)
Mental component summary (n=222,61) 3.16  (9.66) 1.68  (11.31)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fingolimod Standard Disease Modifying Therapy (DMT): Interferon Beta-1a Standard Disease Modifying Therapy: Glatiramer Acetate
Hide Arm/Group Description Participants received 0.5 mg orally once a day. Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week Patients who received glatiramer acetate (GA), 20 mg subcutaneously once a day.
All-Cause Mortality
Fingolimod Standard Disease Modifying Therapy (DMT): Interferon Beta-1a Standard Disease Modifying Therapy: Glatiramer Acetate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fingolimod Standard Disease Modifying Therapy (DMT): Interferon Beta-1a Standard Disease Modifying Therapy: Glatiramer Acetate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/230 (0.87%)   0/28 (0.00%)   0/36 (0.00%) 
Injury, poisoning and procedural complications       
Foot Fracture  1  1/230 (0.43%)  0/28 (0.00%)  0/36 (0.00%) 
Renal and urinary disorders       
Renal colic  1  1/230 (0.43%)  0/28 (0.00%)  0/36 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDdra
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fingolimod Standard Disease Modifying Therapy (DMT): Interferon Beta-1a Standard Disease Modifying Therapy: Glatiramer Acetate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/230 (16.96%)   13/28 (46.43%)   10/36 (27.78%) 
Blood and lymphatic system disorders       
Lymphopenia  1  27/230 (11.74%)  0/28 (0.00%)  2/36 (5.56%) 
General disorders       
Influenza like illness  1  0/230 (0.00%)  10/28 (35.71%)  0/36 (0.00%) 
Injection site pain  1  0/230 (0.00%)  1/28 (3.57%)  6/36 (16.67%) 
Injection site erythema  1  0/230 (0.00%)  0/28 (0.00%)  3/36 (8.33%) 
Injection site extravasation  1  0/230 (0.00%)  0/28 (0.00%)  2/36 (5.56%) 
Investigations       
Gamma-Glutamyltransferase increased  1  13/230 (5.65%)  1/28 (3.57%)  0/36 (0.00%) 
Alanine aminotransferase increased  1  11/230 (4.78%)  2/28 (7.14%)  0/36 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
Name/Title: Study Director
Organization: Novartis
Phone: +1 (862) 778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01534182     History of Changes
Other Study ID Numbers: CFTY720DRU01
First Submitted: February 8, 2012
First Posted: February 16, 2012
Results First Submitted: June 11, 2014
Results First Posted: August 8, 2014
Last Update Posted: August 8, 2014