A Phase 4 interventional study of dimethyl fumarate and acetylsalicylic acid in Relapsing-Remitting Multiple Sclerosis, sponsored by Biogen. Completed at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-28.
Sponsored by Biogen · Phase 4, Interventional, and Treatment
The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin (acetylsalicylic acid [ASA]) taken twice a day (BID) with dimethyl fumarate (DMF) administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF administration reduces the incidence and/or severity of flushing events in subjects with relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF in the clinical practice setting.
Secondary objectives of this study are: to evaluate the safety and tolerability of DMF administered with and without enteric-coated ASA in the clinical practice setting; to evaluate the impact of DMF administration on quality of life as measured by the Short Form 36 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's enrollment of 241 is above the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg is taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.)
Drug: dimethyl fumarate · Drug: acetylsalicylic acid
DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg is taken in the morning (QAM) and ASA-Placebo is taken in the evening (QPM) from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.)
Drug: dimethyl fumarate · Drug: acetylsalicylic acid · Drug: ASA-Placebo
DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo is taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA is prohibited; between Weeks 9 and 48, ASA is allowed as needed.)
Drug: dimethyl fumarate · Drug: ASA-Placebo
Also known as: BG00012, Tecfidera, DMF
enteric-coated capsule
Also known as: ASA, aspirin
matched placebo
Also known as: placebo
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)
Participant-reported flushing events during the first 4 weeks treatment, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.
Time frame: Day 2 to Week 4
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)
Participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Day 1 to Week 4
Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MGFSS
Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.
Time frame: Day 2 to Week 4
Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS
Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Day 1 to Week 4
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MGFSS
Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Week 5 to Week 12
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Week 5 to Week 12
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MGFSS
Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Week 5 to Week 12
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Week 5 to Week 12
Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MGFSS
Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Time frame: Day 1 to Week 12
Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MFSS
Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). For participants with more than 1 flushing event during a visit interval, the average duration for the visit interval was used.
Time frame: Day 1 to Week 12
Number of Participants With Self-Reported Flushing Events During Weeks 13 to 48
Participant-reported flushing events (which include redness, warmth, tingling, and/or itching of the skin) during Weeks 13 to 48 of treatment were recorded in the CRF.
Time frame: Week 13 to Week 48
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.
Time frame: Day 1 to Week 12
Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.
Time frame: Week 13 to Week 48
Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-emergent Flushing AEs in the First 12 Weeks
A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.
Time frame: Day 1 to Week 12
Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-Emergent Flushing AEs in Weeks 13 to 48
A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.
Time frame: Week 13 to Week 48
Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Physical Component Summary (PCS)
SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).
Time frame: Baseline, Week 24, Week 48 or early termination (ET)
Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Mental Component Summary (MCS)
SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).
Time frame: Baseline, Week 24, Week 48 or ET
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) Questionnaire: Mobility
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 24, Week 48 or ET
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Self-Care
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 24, Week 48 or ET
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Usual Activities
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 24, Week 48 or ET
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Pain/Discomfort
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 24, Week 48 or ET
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Anxiety/Depression
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Time frame: Baseline, Week 24, Week 48 or ET
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-VAS
For the EQ-VAS, the participant was instructed to draw a line on a 20-cm vertical scale at the point that best describes his or her own health, where 0 represents the "worst imaginable health state" and 100 represents the "best imaginable health state."
Time frame: Baseline, Week 24, Week 48 or ET
| Milestone | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Started | 81 | 80 | 80 |
| Completed | 62 | 60 | 57 |
| Not completed | 19 | 20 | 23 |
| Withdrew: Adverse event | 11 | 15 | 20 |
| Withdrew: Flushing event | 2 | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 2 | 2 |
| Withdrew: Investigator decision | 1 | 1 | 0 |
| Withdrew: Other | 2 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 |
Participant-reported flushing events during the first 4 weeks treatment, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.
| percentage of participants | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Weeks 1-4 combined; n=80, 79, 80 | 90.0 | 92.4 | 88.8 |
| Week 1; n=80, 77, 80 | 83.8 | 85.7 | 83.8 |
| Week 2; n=77, 76, 79 | 76.6 | 61.8 | 69.6 |
| Week 3; n=74, 74, 76 | 73.0 | 55.4 | 53.9 |
| Week 4; n=72, 71, 71 | 59.7 | 54.9 | 54.9 |
Participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
| percentage of participants | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Overall flushing events | 91.3 | 96.2 | 96.3 |
| Overall redness events | 90.0 | 88.5 | 88.8 |
| Overall warmth events | 92.5 | 97.4 | 97.5 |
| Overall tingling events | 81.3 | 87.2 | 86.3 |
| Overall itching events | 87.5 | 79.5 | 76.3 |
Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MGFSS | 4.36 ± 2.66 | 3.99 ± 2.63 | 3.93 ± 2.47 |
Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Overall flushing | 4.84 ± 2.77 | 4.73 ± 2.43 | 4.78 ± 2.53 |
| Redness | 4.83 ± 2.69 | 4.65 ± 2.73 | 4.34 ± 2.67 |
| Warmth | 5.03 ± 2.54 | 4.88 ± 2.38 | 4.9 ± 2.46 |
| Tingling | 3.31 ± 2.38 | 3.62 ± 2.53 | 3.3 ± 2.30 |
| Itching | 3.7 ± 2.55 | 3.64 ± 2.76 | 3.23 ± 2.66 |
Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
| percentage of participants | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Weeks 5-8 combined; n=71, 71, 70 | 74.6 | 73.2 | 80.0 |
| Weeks 9-12 combined; n=67, 62, 65 | 61.2 | 67.7 | 76.9 |
Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
| percentage of participants | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Overall Flushing, Weeks 5-8 combined; n=71, 70, 70 | 80.3 | 82.9 | 84.3 |
| Overall Flushing, Weeks 9-12 combined;n=68, 65, 65 | 66.2 | 69.2 | 78.5 |
| Redness, Weeks 5-8 combined; n=71, 70, 70 | 77.5 | 75.7 | 81.4 |
| Redness, Weeks 9-12 combined; n=68, 65, 65 | 70.6 | 61.5 | 73.8 |
| Warmth, Weeks 5-8 combined; n=71, 70, 70 | 80.3 | 80.0 | 82.9 |
| Warmth, Weeks 9-12 combined; n=68, 65, 65 | 70.6 | 70.8 | 75.4 |
| Tingling, Weeks 5-8 combined; n=71, 70, 70 | 57.7 | 55.7 | 71.4 |
| Tingling, Weeks 9-12 combined; n=68, 65, 65 | 54.4 | 49.2 | 61.5 |
| Itching, Weeks 5-8 combined; n=71, 70, 70 | 54.9 | 64.3 | 64.3 |
| Itching, Weeks 9-12 combined; n=68, 65, 65 | 48.5 | 52.3 | 56.9 |
Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Weeks 5-8 combined; n=71, 71, 70 | 3.00 ± 2.61 | 2.83 ± 2.4 | 3.47 ± 2.64 |
| Weeks 9 to 12 combined; n=67, 62, 65 | 2.43 ± 2.72 | 2.81 ± 2.76 | 2.95 ± 2.5 |
Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Overall Flushing, Weeks 5-8 combined; n=71, 70, 70 | 3.37 ± 2.8 | 3.24 ± 2.57 | 3.57 ± 2.45 |
| Overall Flushing, Weeks 9-12 combined;n=68, 65, 65 | 2.5 ± 2.65 | 3.15 ± 2.98 | 3.45 ± 2.74 |
| Redness, Weeks 5-8 combined; n=71, 70, 70 | 3.27 ± 2.9 | 2.83 ± 2.54 | 3.51 ± 2.58 |
| Redness, Weeks 9-12 combined; n=68, 65, 65 | 2.57 ± 2.55 | 2.75 ± 3.13 | 3.4 ± 2.93 |
| Warmth, Weeks 5-8 combined; n=71, 70, 70 | 3.3 ± 2.71 | 3.11 ± 2.45 | 3.49 ± 2.54 |
| Warmth, Weeks 9-12 combined; n=68, 65, 65 | 2.66 ± 2.52 | 3.06 ± 2.97 | 3.45 ± 2.85 |
| Tingling, Weeks 5-8 combined; n=71, 70, 70 | 2.03 ± 2.41 | 2.07 ± 2.5 | 2.79 ± 2.56 |
| Tingling, Weeks 9-12 combined; n=68, 65, 65 | 1.71 ± 2.17 | 1.78 ± 2.43 | 2.54 ± 2.69 |
| Itching, Weeks 5-8 combined; n=71, 70, 70 | 1.92 ± 2.35 | 2.17 ± 2.32 | 2.64 ± 2.59 |
| Itching, Weeks 9-12 combined; n=68, 65, 65 | 1.51 ± 2.04 | 1.69 ± 2.15 | 2.17 ± 2.52 |
Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
No measurements were reported for this outcome.
Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). For participants with more than 1 flushing event during a visit interval, the average duration for the visit interval was used.
| hours | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Weeks 1-4 combined; n=73, 75, 77 | 0.69 ± 0.44 | 0.8 ± 0.59 | 1.11 ± 1.16 |
| Weeks 5-8 combined; n=57, 58, 59 | 1.06 ± 2.12 | 0.73 ± 0.52 | 1.08 ± 1.18 |
| Weeks 9-12 combined; n=45, 45, 51 | 0.66 ± 0.52 | 0.69 ± 0.59 | 0.79 ± 0.94 |
Participant-reported flushing events (which include redness, warmth, tingling, and/or itching of the skin) during Weeks 13 to 48 of treatment were recorded in the CRF.
| participants | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Number of Participants With Self-Reported Flushing Events During Weeks 13 to 48 | 36 | 35 | 42 |
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.
| participants | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Any event | 66 | 68 | 63 |
| Moderate or severe event | 24 | 38 | 26 |
| Severe event | 3 | 5 | 8 |
| Related event | 35 | 38 | 40 |
| Serious event | 1 | 1 | 2 |
| Discontinued treatment due to event | 5 | 9 | 12 |
| Discontinued study due to event | 5 | 9 | 13 |
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.
| participants | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Any event | 66 | 68 | 66 |
| Moderate or severe event | 40 | 50 | 51 |
| Severe event | 5 | 12 | 12 |
| Related event | 45 | 42 | 49 |
| Serious event | 3 | 7 | 3 |
| Discontinued treatment due to event | 9 | 6 | 10 |
| Discontinued study due to event | 9 | 6 | 10 |
A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.
| participants | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Discontinuing treatment | 0 | 0 | 2 |
| Discontinuing study | 0 | 0 | 2 |
A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.
| participants | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Discontinuing treatment | 2 | 0 | 0 |
| Discontinuing study | 2 | 0 | 0 |
SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Baseline; n=81, 80, 80 | 44.627 ± 10.822 | 41.99 ± 10.966 | 43.16 ± 11.438 |
| Change at Week 24; n=68, 63, 61 | -0.014 ± 9.154 | 0.551 ± 8.473 | -1.471 ± 7.754 |
| Change at Week 48/ET; n=68, 65, 64 | -1.008 ± 10.31 | -1.449 ± 10.964 | -2.989 ± 14.22 |
SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Baseline; n=81, 80, 80 | 47.413 ± 8.772 | 45.048 ± 10.531 | 46.496 ± 10.812 |
| Change at Week 24; n=68, 63, 61 | -0.139 ± 11.66 | -0.893 ± 10.059 | -0.312 ± 12.251 |
| Change at Week 48/ET; n=68, 65, 64 | -0.976 ± 13.759 | -2.081 ± 13.733 | -2.82 ± 15.465 |
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Baseline; n=81, 79, 80 | 1.877 ± 0.967 | 1.785 ± 0.887 | 1.888 ± 0.928 |
| Change at Week 24; n=67, 63, 60 | -0.104 ± 0.606 | 0.095 ± 1.214 | -0.05 ± 0.467 |
| Change at Week 48/ET; n=67, 63, 63 | 0.03 ± 0.627 | 0.079 ± 1.021 | 0.095 ± 0.56 |
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Baseline; n=81, 79, 80 | 1.321 ± 0.668 | 1.38 ± 0.722 | 1.363 ± 0.621 |
| Change at Week 24; n=67, 63, 60 | -0.045 ± 0.442 | -0.079 ± 1.182 | 0.017 ± 0.567 |
| Change at Week 48/ET; n=67, 64, 63 | -0.045 ± 0.367 | -0.109 ± 1.143 | 0.079 ± 0.604 |
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Baseline; n=81, 79, 80 | 1.827 ± 0.891 | 1.975 ± 0.947 | 2.025 ± 0.993 |
| Change at Week 24; n=67, 63, 60 | -0.06 ± 0.694 | 0 ± 1.244 | -0.017 ± 0.725 |
| Change at Week 48/ET; n=67, 64, 63 | 0.149 ± 0.783 | -0.016 ± 1.105 | 0.063 ± 0.896 |
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Baseline; n=81, 79, 80 | 2 ± 0.88 | 2.038 ± 0.869 | 1.975 ± 0.941 |
| Change at Week 24; n=67, 63, 60 | -0.104 ± 0.699 | 0 ± 1.032 | 0.1 ± 0.573 |
| Change at Week 48/ET; n=67, 64, 63 | -0.09 ± 0.712 | 0.078 ± 1.117 | -0.127 ± 0.707 |
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Baseline; n=81, 79, 80 | 1.642 ± 0.763 | 1.848 ± 0.893 | 1.763 ± 0.917 |
| Change at Week 24; n=67, 63, 60 | -0.06 ± 0.903 | -0.19 ± 1.293 | 0 ± 0.803 |
| Change at Week 48/ET; n=67, 63, 63 | 0.03 ± 0.953 | -0.127 ± 1.184 | -0.032 ± 0.842 |
For the EQ-VAS, the participant was instructed to draw a line on a 20-cm vertical scale at the point that best describes his or her own health, where 0 represents the "worst imaginable health state" and 100 represents the "best imaginable health state."
| units on a scale | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Baseline; n=80, 80, 80 | 78.288 ± 16.442 | 69.6 ± 19.535 | 73.438 ± 16.38 |
| Change at Week 24; n=66, 63, 60 | -2.318 ± 12.579 | -0.587 ± 17.24 | -2.95 ± 16.326 |
| Change at Week 48/ET; n=66, 64, 63 | -3.061 ± 18.053 | -0.438 ± 17.834 | -1.476 ± 13.201 |
Collected over Screening through Week 48. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DMF + ASA-Placebo BID | — | 4/81 (4.9%) | 77/81 (95.1%) |
| DMF + ASA 75 mg QAM | — | 8/80 (10%) | 76/80 (95%) |
| DMF + ASA 150 mg BID | — | 5/80 (6.3%) | 76/80 (95%) |
| Event | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 0/81 | 2/80 | 1/80 |
| Multiple sclerosis relapseNervous system disorders | 0/81 | 2/80 | 0/80 |
| AppendicitisInfections and infestations | 0/81 | 1/80 | 0/80 |
| GastroenteritisInfections and infestations | 0/81 | 1/80 | 0/80 |
| PeritonitisInfections and infestations | 0/81 | 1/80 | 0/80 |
| PneumoniaInfections and infestations | 0/81 | 0/80 | 1/80 |
| Drug intoleranceGeneral disorders | 0/81 | 0/80 | 1/80 |
| PainGeneral disorders | 0/81 | 1/80 | 0/80 |
| Gastrointestinal disorderGastrointestinal disorders | 0/81 | 0/80 | 1/80 |
| AbasiaGeneral disorders | 0/81 | 1/80 | 0/80 |
| Event | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID |
|---|---|---|---|
| FlushingVascular disorders | 42/81 | 36/80 | 45/80 |
| NauseaGastrointestinal disorders | 12/81 | 16/80 | 23/80 |
| DiarrhoeaGastrointestinal disorders | 17/81 | 21/80 | 19/80 |
| NasopharyngitisInfections and infestations | 20/81 | 15/80 | 16/80 |
| HeadacheNervous system disorders | 16/81 | 14/80 | 18/80 |
| VomitingGastrointestinal disorders | 14/81 | 14/80 | 14/80 |
| Multiple sclerosis relapseNervous system disorders | 5/81 | 12/80 | 5/80 |
| PruritusSkin and subcutaneous tissue disorders | 5/81 | 11/80 | 4/80 |
| FatigueGeneral disorders | 9/81 | 11/80 | 7/80 |
| Abdominal painGastrointestinal disorders | 8/81 | 5/80 | 10/80 |
| Age, Continuous(years) | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID | Total |
|---|---|---|---|---|
| Mean | 40.17 ± 10.63 | 39.48 ± 8.48 | 40.16 ± 8.23 | 39.94 ± 9.15 |
| Gender(Participants) | DMF + ASA-Placebo BID | DMF + ASA 75 mg QAM | DMF + ASA 150 mg BID | Total |
|---|---|---|---|---|
| Female | 59 | 62 | 60 | 181 |
| Male | 22 | 18 | 20 | 60 |
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