Relapsing-Remitting Multiple Sclerosis (RRMS)
Conditions
Brief summary
The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants' satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants' adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on participants' injection-system satisfaction; Evaluate the relationship between participants' satisfaction and adherence; Evaluate the relationship between participants' satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (annualized relapse rate \[ARR\], disability, etc.) and to evaluate the treatment safety and tolerability.
Interventions
125 mcg administered subcutaneously (SC) every 2 weeks.
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects diagnosed with Relapsing Remitting MS according to 2010 McDonald criteria. * Subjects with EDSS score between 0.0 and 5.0 at baseline. Key
Exclusion criteria
* Pregnancy or breast-feeding. * Have any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12 | Baseline, Week 12 | TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | Adherence to treatment was evaluated using a questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration. Participants who had taken the prescribed doses of treatment in the previous 28 days were evaluated. |
| Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | FSS is a questionnaire composed of nine statements on the state of fatigue experienced during the previous week. The answers are within a scale of agreement ranging from 1 to 7, where 1 represents less fatigue and 7 indicates highest fatigue. The total score was obtained summing the number given at each item and it ranges from 7 to 63. An overall score of ≥36 indicates a state of fatigue. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit. Here, negative values indicate improvement in FSS score from baseline. |
| Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | MSTCQ is a 20-item questionnaire adapted for 'Peg-interferon Beta 1a' containing two domains: injection system satisfaction (1-9) and side effects (1-11). All questions in the MSTCQ have a five-point response choice, with a minimum possible total score of 20 and a maximum possible total score of 100. Lower total scores indicating better outcomes. Questionnaires were completed electronically by participants, by means of a participant I-PAD at each study visit. Here, negative values indicate improvement in MSTCQ score from baseline. |
| Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 | Baseline, Weeks 12 and 24 | MusiQoL is a self-administered questionnaire consisting of 31 items describing nine dimensions of health-related quality of life (QoL): activities of daily living, psychological wellbeing, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping rejection, relationship with healthcare system). All items are scored based on frequency/extent of an event on a five-point scale ranging from never/not at all (option 1) to always/very much (option 5). Total score is obtained by linearly transforming and standardizing on a 0-100 scale. Higher scores indicate a better level of health-related QoL for each dimension and for the global index score. Here, negative values indicate improvement in MusiQoL score from baseline. |
| Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 | Baseline, Week 24 | TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit. |
| Percent Change in Relapse-Free Participants at Week 24 | Baseline, Week 24 | Relapses are defined as neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event. Percent change in relapse-free participants had been calculated with respect to the number of relapse-free participants at baseline. Here, negative sign indicates decrease in number of relapse free participants at specified timepoint as compared to baseline. |
| Number of Participants With Adverse Events (AE) | Baseline up to Week 24 | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can herefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Number of Participants With AE Stratified by Severity | Baseline up to Week 24 | Severity of AEs was evaluated based on the following criteria- Mild: Symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate: Symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe: Symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. |
| Number of Participants With Clinical Abnormal Laboratory Values | Baseline up to Week 24 | Participants with clinical abnormal laboratory values were reported throughout the studies. |
| Change From Baseline in Annualized Relapse Rate (ARR) at Week 24 | Baseline, Week 24 | Relapses are defined as neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event. ARR was calculated as the total number of relapses for all participants divided by the total participant-years of exposure to that treatment. Here negative sign indicates decrease in annual relapse rate as compared to baseline. |
Countries
Italy
Participant flow
Recruitment details
Participants were recruited from 32 sites in Italy.
Pre-assignment details
A total of 193 participants with relapsing remitting multiple sclerosis (RRMS) were enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| Peg-interferon Beta-1a 125 μg Participants received peg-interferon beta-1a 63 μg on Day 1 followed by peg-interferon beta-1a 94 μg on Day 14 in the titration phase. Participants received per-interferon beta-1a on Day 28 and then every 2 weeks for up to 12 months. | 193 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Discontinuation of Study Medication | 2 |
| Overall Study | Non-adherence to the Protocol | 3 |
| Overall Study | Reason not Specified | 3 |
| Overall Study | Withdrawal of Informed Consent (IC) | 5 |
Baseline characteristics
| Characteristic | Peg-interferon Beta-1a 125 μg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 193 Participants |
| Age, Continuous | 42.0 years STANDARD_DEVIATION 10.6 |
| Race/Ethnicity, Customized Caucasian | 192 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Sex: Female, Male Female | 135 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 193 |
| other Total, other adverse events | 44 / 193 |
| serious Total, serious adverse events | 0 / 193 |
Outcome results
Primary
Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12
TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit.
Time frame: Baseline, Week 12
Population: FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12 | Change at Week 12 | 38.5 score on a scale | Standard Deviation 23.3 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12 | Baseline | 38.5 score on a scale | Standard Deviation 13.9 |
Comparison: Adjusted change of convenience satisfaction domain of TSQM-9.p-value: 0.5695% CI: [-3.72, 2.02]Mixed-effects REML regression
Secondary
Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24
MSTCQ is a 20-item questionnaire adapted for 'Peg-interferon Beta 1a' containing two domains: injection system satisfaction (1-9) and side effects (1-11). All questions in the MSTCQ have a five-point response choice, with a minimum possible total score of 20 and a maximum possible total score of 100. Lower total scores indicating better outcomes. Questionnaires were completed electronically by participants, by means of a participant I-PAD at each study visit. Here, negative values indicate improvement in MSTCQ score from baseline.
Time frame: Baseline, Weeks 12 and 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 | Change at Week 24 | -19.4 score on a scale | Standard Deviation 17.1 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 | Baseline | 71.9 score on a scale | Standard Deviation 14 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 | Change at Week 12 | -16.8 score on a scale | Standard Deviation 16.9 |
Secondary
Change From Baseline in Annualized Relapse Rate (ARR) at Week 24
Relapses are defined as neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event. ARR was calculated as the total number of relapses for all participants divided by the total participant-years of exposure to that treatment. Here negative sign indicates decrease in annual relapse rate as compared to baseline.
Time frame: Baseline, Week 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Annualized Relapse Rate (ARR) at Week 24 | Baseline | 0.15 relapses per participant-year |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Annualized Relapse Rate (ARR) at Week 24 | Change at Week 24 | -0.03 relapses per participant-year |
Secondary
Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24
FSS is a questionnaire composed of nine statements on the state of fatigue experienced during the previous week. The answers are within a scale of agreement ranging from 1 to 7, where 1 represents less fatigue and 7 indicates highest fatigue. The total score was obtained summing the number given at each item and it ranges from 7 to 63. An overall score of ≥36 indicates a state of fatigue. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit. Here, negative values indicate improvement in FSS score from baseline.
Time frame: Baseline, Weeks 12 and 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 | Baseline | 40.1 score on a scale | Standard Deviation 15.6 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 | Change at Week 12 | -4.6 score on a scale | Standard Deviation 13.1 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 | Change at Week 24 | -3.8 score on a scale | Standard Deviation 13.1 |
Secondary
Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24
MusiQoL is a self-administered questionnaire consisting of 31 items describing nine dimensions of health-related quality of life (QoL): activities of daily living, psychological wellbeing, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping rejection, relationship with healthcare system). All items are scored based on frequency/extent of an event on a five-point scale ranging from never/not at all (option 1) to always/very much (option 5). Total score is obtained by linearly transforming and standardizing on a 0-100 scale. Higher scores indicate a better level of health-related QoL for each dimension and for the global index score. Here, negative values indicate improvement in MusiQoL score from baseline.
Time frame: Baseline, Weeks 12 and 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 | Baseline | 67.8 score on a scale | Standard Deviation 16.5 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 | Change at Week 12 | 4.6 score on a scale | Standard Deviation 14.89 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 | Change at Week 24 | 5.0 score on a scale | Standard Deviation 14.2 |
Secondary
Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24
Adherence to treatment was evaluated using a questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration. Participants who had taken the prescribed doses of treatment in the previous 28 days were evaluated.
Time frame: Baseline, Weeks 12 and 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication. Overall number of participants analyzed are the participants who were evaluated for the outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 | Baseline | 113 participants |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 | Change at Week 12 | 65 participants |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 | Change at Week 24 | 53 participants |
Secondary
Change From Baseline in the Score of All Domains of TSQM-9 at Week 24
TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit.
Time frame: Baseline, Week 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peg-interferon Beta-1a 125 μg | Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 | Baseline: Convenience Satisfaction | 38.5 score on a scale | Standard Deviation 13.9 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 | Change at Week 24: Convenience Satisfaction | 41.9 score on a scale | Standard Deviation 22.5 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 | Baseline: Effectiveness | 47.0 score on a scale | Standard Deviation 17.5 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 | Change at Week 24: Effectiveness | 21.2 score on a scale | Standard Deviation 26.9 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 | Baseline: Global satisfaction | 41.4 score on a scale | Standard Deviation 17.3 |
| Peg-interferon Beta-1a 125 μg | Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 | Change at Week 24: Global satisfaction | 27.9 score on a scale | Standard Deviation 26.1 |
Secondary
Number of Participants With Adverse Events (AE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can herefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: Baseline up to Week 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peg-interferon Beta-1a 125 μg | Number of Participants With Adverse Events (AE) | 82 Participants |
Secondary
Number of Participants With AE Stratified by Severity
Severity of AEs was evaluated based on the following criteria- Mild: Symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate: Symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe: Symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized.
Time frame: Baseline up to Week 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Peg-interferon Beta-1a 125 μg | Number of Participants With AE Stratified by Severity | Mild | 55 Participants |
| Peg-interferon Beta-1a 125 μg | Number of Participants With AE Stratified by Severity | Moderate | 27 Participants |
Secondary
Number of Participants With Clinical Abnormal Laboratory Values
Participants with clinical abnormal laboratory values were reported throughout the studies.
Time frame: Baseline up to Week 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Peg-interferon Beta-1a 125 μg | Number of Participants With Clinical Abnormal Laboratory Values | Baseline | 4 Participants |
| Peg-interferon Beta-1a 125 μg | Number of Participants With Clinical Abnormal Laboratory Values | Week 12 | 3 Participants |
| Peg-interferon Beta-1a 125 μg | Number of Participants With Clinical Abnormal Laboratory Values | Week 24 | 3 Participants |
Secondary
Percent Change in Relapse-Free Participants at Week 24
Relapses are defined as neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event. Percent change in relapse-free participants had been calculated with respect to the number of relapse-free participants at baseline. Here, negative sign indicates decrease in number of relapse free participants at specified timepoint as compared to baseline.
Time frame: Baseline, Week 24
Population: FAS population included all enrolled participants who took at least one dose of the study medication. Number of participants analyzed are the participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peg-interferon Beta-1a 125 μg | Percent Change in Relapse-Free Participants at Week 24 | -7.94 percentage change |