Multiple Sclerosis, Relapsing, Remitting
Conditions
Keywords
Multiple sclerosis, relapsing, remitting, Interferon-beta
Brief summary
This study is planned to evaluate emotional disorders during treatment by interferon (IFN) beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label exploratory study with no change of therapeutic behavior but with standardized neuropsychologic follow-up.
Detailed description
This study is planned to evaluate emotional disorders during treatment by IFN beta in RRMS subjects. This is an open-label, prospective, interventional, multicentric study with no change of therapeutic behavior but with standardized neuropsychologic follow-up. Subjects will undergo 13 evaluations (categorical and dimensional evaluations), 3 evaluations will be performed before the treatment (Baseline, Day 7 and 15) and 10 evaluations after the treatment (Month 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24).
Interventions
DRUGInterferon beta-1a
Sponsors
Merck Serono S.A.S, France
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female subjects aged ≥ 18 years * Subjects with RRMS * Subjects with at least 2 relapses in the past two years (with last relapse finished or finishing) * Subjects with indication of IFN beta treatment determined by the investigator * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Subjects with secondary progressive multiple sclerosis (MS) without relapse * Subjects with ongoing acute relapse * Subjects already being treated with interferon * Subjects with corticoid therapy for less than 15 days * Subjects presenting acute major depression or treated with anti-depressant therapy * Subjects involved in another therapeutic study * Subjects with any condition which could interfere with a good compliance of this study * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12 | Baseline and Month 12 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007) |
| Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18 | Baseline and Month 18 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007) |
| Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24 | Baseline and Month 24 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996) |
| Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007) |
| Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Baseline, Months 1, 2, 3, 6, 12, and 24 | Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999) |
| Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983) |
| Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interferon-beta Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Participant wrongly included in trial | 1 |
| Overall Study | Randomized, not treated | 3 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Interferon-beta |
|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 62 / 76 |
| serious Total, serious adverse events | 9 / 76 |
Outcome results
Primary
Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Time frame: Baseline and Month 12
Population: Intent-to-treat (ITT) population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interferon-beta | Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12 | Change at Month 12 (n= 57) | -0.5 units on a scale | Standard Deviation 4.2 |
| Interferon-beta | Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12 | Baseline (n= 70) | 12.7 units on a scale | Standard Deviation 4.4 |
Primary
Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Time frame: Baseline and Month 18
Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interferon-beta | Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18 | -0.6 units on a scale | Standard Deviation 4.6 |
Primary
Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Time frame: Baseline and Month 24
Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interferon-beta | Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24 | -0.1 units on a scale | Standard Deviation 5.2 |
Secondary
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977)
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Baseline (n= 70) | 13.5 units on a scale | Standard Deviation 11.1 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 24 (n= 63) | 0.1 units on a scale | Standard Deviation 10.1 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 1 (n= 65) | 1.0 units on a scale | Standard Deviation 8.6 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 2 (n= 62) | 1.5 units on a scale | Standard Deviation 10.6 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 3 (n= 64) | -0.5 units on a scale | Standard Deviation 9.9 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 4 (n= 58) | -1.0 units on a scale | Standard Deviation 9.8 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 5 (n= 58) | -1.1 units on a scale | Standard Deviation 8.6 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 6 (n= 56) | 0.9 units on a scale | Standard Deviation 9.2 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 9 (n= 58) | 0.9 units on a scale | Standard Deviation 10.7 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 12 (n= 57) | 1.6 units on a scale | Standard Deviation 10.8 |
| Interferon-beta | Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 18 (n= 61) | -0.2 units on a scale | Standard Deviation 9 |
Secondary
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996)
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Baseline (n= 70) | 16.8 units on a scale | Standard Deviation 4.1 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 1 (n= 65) | 0.0 units on a scale | Standard Deviation 4.2 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 4 (n= 59) | -0.3 units on a scale | Standard Deviation 4.7 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 5 (n= 58) | -0.0 units on a scale | Standard Deviation 2.9 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 24 (n= 63) | 1.0 units on a scale | Standard Deviation 5.5 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 2 (n= 62) | 1.0 units on a scale | Standard Deviation 5.3 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 3 (n= 64) | -0.0 units on a scale | Standard Deviation 5.3 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 6 (n= 56) | 1.1 units on a scale | Standard Deviation 7.6 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 9 (n= 58) | 1.1 units on a scale | Standard Deviation 5.9 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 12 (n= 57) | 0.9 units on a scale | Standard Deviation 5.7 |
| Interferon-beta | Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 18 (n= 61) | 0.8 units on a scale | Standard Deviation 5.4 |
Secondary
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007)
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Baseline (n= 70) | 5.6 units on a scale | Standard Deviation 1.6 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 1 (n= 64) | 0.3 units on a scale | Standard Deviation 1.6 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 2 (n= 62) | -0.1 units on a scale | Standard Deviation 1.7 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 3 (n= 64) | -0.0 units on a scale | Standard Deviation 1.6 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 12 (n= 57) | -0.0 units on a scale | Standard Deviation 2.3 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 18 (n= 61) | -0.3 units on a scale | Standard Deviation 1.9 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 24 (n= 63) | -0.3 units on a scale | Standard Deviation 1.7 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 4 (n= 59) | -0.0 units on a scale | Standard Deviation 1.8 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 5 (n= 58) | -0.2 units on a scale | Standard Deviation 1.5 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 6 (n= 56) | -0.3 units on a scale | Standard Deviation 1.8 |
| Interferon-beta | Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 9 (n= 58) | -0.1 units on a scale | Standard Deviation 1.8 |
Secondary
Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999)
Time frame: Baseline, Months 1, 2, 3, 6, 12, and 24
Population: ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interferon-beta | Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Baseline (n= 62) | 2.1 units on a scale | Standard Deviation 1.7 |
| Interferon-beta | Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Change at Month 1 (n= 58) | 0.5 units on a scale | Standard Deviation 1.6 |
| Interferon-beta | Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Change at Month 2 (n= 55) | 0.4 units on a scale | Standard Deviation 1.5 |
| Interferon-beta | Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Change at Month 12 (n= 49) | 0.1 units on a scale | Standard Deviation 1.8 |
| Interferon-beta | Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Change at Month 24 (n= 56) | -0.1 units on a scale | Standard Deviation 2.1 |
| Interferon-beta | Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Change at Month 3 (n= 56) | 0.2 units on a scale | Standard Deviation 1.8 |
| Interferon-beta | Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 | Change at Month 6 (n= 50) | 0.4 units on a scale | Standard Deviation 1.8 |
Secondary
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983)
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Baseline (n= 70) | 35.9 units on a scale | Standard Deviation 11.8 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 1 (n= 65) | 0.8 units on a scale | Standard Deviation 10.5 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 2 (n= 62) | 0.3 units on a scale | Standard Deviation 12.3 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 3 (n= 64) | -1.7 units on a scale | Standard Deviation 11.5 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 5 (n= 58) | -0.8 units on a scale | Standard Deviation 9.2 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 6 (n= 55) | -1.4 units on a scale | Standard Deviation 11.5 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 18 (n= 61) | -1.2 units on a scale | Standard Deviation 11.2 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 24 (n= 63) | -1.4 units on a scale | Standard Deviation 13.1 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 4 (n= 59) | -1.5 units on a scale | Standard Deviation 11 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 9 (n= 58) | -0.2 units on a scale | Standard Deviation 10.5 |
| Interferon-beta | Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 | Change at Month 12 (n= 57) | -0.3 units on a scale | Standard Deviation 12.7 |