Relapsing Multiple Sclerosis
Conditions
Keywords
Relapsing Multiple Sclerosis
Brief summary
To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.
Interventions
DRUGLaquinimod
One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subjects must have completed the Termination visit of MS-LAQ-302 (completion of all Termination visit activities) according to the MS-LAQ-302 protocol. 2. Women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this open label extension phase include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)\] during the study and up to 30 days after the last dose of the study drug.. 3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study. 4. Subjects must be able to comprehend, sign and date a written informed consent prior to entering the MS-LAQ-302E study.
Exclusion criteria
1. Premature discontinuation from the MS-LAQ-302 study, for any reason. 2. Pregnancy \[according to urine dipstick β-HCG test performed at Baseline (Month 0E) visit\] or breastfeeding. 3. Subjects with clinically significant or unstable medical or surgical condition detected or worsened during the MS-LAQ-302 study, which preclude safe participation and completion of the MS-LAQ-302E study. Acute exacerbation of MS will not exclude participation in the MS-LAQ-302E study. 4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to 7.13 years | A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Potentially Clinically Significant Abnormal Vital Signs | Baseline (Day 0 for extension), Day 1 up to 7.13 years | Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria: * Pulse rate: \>=120 and increase \>=30 beats/minute * Systolic blood pressure low: \<=90 and decrease \>=30 mmHg * Systolic blood pressure high: \>=180 and increase \>=30 mmHg * Diastolic blood pressure low: \<=50 and decrease \>=20 mmHg * Diastolic blood pressure high: \>=100 and increase \>=20 mmHg Note that the change is compared to baseline, |
| Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Baseline (Day 0), Day 1 to 7.13 years | Counts include two conditions: * a change from High / Non-PCS at baseline to Low PCS at any point during the study * a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count. ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassium |
| Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Baseline (Day 0), Day 1 to 7.13 years | Counts include two conditions: * a change from High / Non-PCS at baseline to Low PCS at any point during the study * a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count. |
| Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Baseline (Day 0), Day 1 to 7.13 years | Shifts are presented as Baseline finding / Worse finding at anytime during the study. Categories for findings are: * normal * abnormal, not clinically significant (Not CS) * abnormal, clinically significant (CS) |
Countries
Bulgaria, Croatia, Czechia, Estonia, Georgia, Germany, Israel, Italy, Lithuania, North Macedonia, Poland, Romania, Russia, Slovakia, South Africa, Spain, Ukraine, United States
Participant flow
Recruitment details
All participants who completed the full duration of the double-blind BRAVO study (study MS-LAQ-302) were eligible to enter into Study MS-LAQ-302E. Of the 1090 participants who completed MS-LAQ-302, 1047 opted to continue into the open-label extension study.
Pre-assignment details
1047 subjects with RRMS were enrolled to receive laquinimod 0.6 mg daily at 144 study sites in 18 countries by 144 investigators.
Participants by arm
| Arm | Count |
|---|---|
| Early Laquinimod All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months. | 345 |
| Switch From Placebo All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months. | 350 |
| Switch From Avonex All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months. | 352 |
| Total | 1,047 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 16 | 27 | 21 |
| Overall Study | Death | 5 | 1 | 5 |
| Overall Study | Lack of Efficacy | 4 | 3 | 3 |
| Overall Study | Lost to Follow-up | 14 | 10 | 10 |
| Overall Study | Physician Decision | 12 | 9 | 10 |
| Overall Study | Pregnancy | 13 | 8 | 8 |
| Overall Study | Protocol Violation | 3 | 2 | 4 |
| Overall Study | Study terminated by Sponsor | 198 | 215 | 203 |
| Overall Study | Teva requested participant withdrawal | 3 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 77 | 75 | 87 |
Baseline characteristics
| Characteristic | Early Laquinimod | Switch From Placebo | Switch From Avonex | Total |
|---|---|---|---|---|
| Age, Continuous | 39.2 years STANDARD_DEVIATION 9.16 | 40.1 years STANDARD_DEVIATION 9.23 | 40.1 years STANDARD_DEVIATION 9.34 | 39.8 years STANDARD_DEVIATION 9.24 |
| Race/Ethnicity, Customized Asian/Oriental | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 338 Participants | 346 Participants | 348 Participants | 1032 Participants |
| Sex: Female, Male Female | 228 Participants | 245 Participants | 234 Participants | 707 Participants |
| Sex: Female, Male Male | 117 Participants | 105 Participants | 118 Participants | 340 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 345 | 3 / 350 | 5 / 352 |
| other Total, other adverse events | 215 / 345 | 205 / 350 | 194 / 352 |
| serious Total, serious adverse events | 54 / 345 | 65 / 350 | 51 / 352 |
Outcome results
Primary
Participants With Treatment-Emergent Adverse Events (TEAEs)
A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.
Time frame: Day 1 up to 7.13 years
Population: Safety
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Laquinimod | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 Serious TEAE | 54 Participants |
| Early Laquinimod | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE of special interest | 66 Participants |
| Early Laquinimod | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE causing discontinuation | 20 Participants |
| Early Laquinimod | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE | 290 Participants |
| Early Laquinimod | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE leading to death | 5 Participants |
| Early Laquinimod | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 treatment-related TEAE | 66 Participants |
| Early Laquinimod | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 Severe TEAE | 36 Participants |
| Switch From Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE causing discontinuation | 28 Participants |
| Switch From Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE | 303 Participants |
| Switch From Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 Serious TEAE | 65 Participants |
| Switch From Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 Severe TEAE | 54 Participants |
| Switch From Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE of special interest | 64 Participants |
| Switch From Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 treatment-related TEAE | 76 Participants |
| Switch From Placebo | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE leading to death | 3 Participants |
| Switch From Avonex | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE of special interest | 73 Participants |
| Switch From Avonex | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 Serious TEAE | 51 Participants |
| Switch From Avonex | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE leading to death | 5 Participants |
| Switch From Avonex | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 treatment-related TEAE | 96 Participants |
| Switch From Avonex | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE causing discontinuation | 23 Participants |
| Switch From Avonex | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 Severe TEAE | 44 Participants |
| Switch From Avonex | Participants With Treatment-Emergent Adverse Events (TEAEs) | =>1 TEAE | 279 Participants |
Secondary
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Shifts are presented as Baseline finding / Worse finding at anytime during the study. Categories for findings are: * normal * abnormal, not clinically significant (Not CS) * abnormal, clinically significant (CS)
Time frame: Baseline (Day 0), Day 1 to 7.13 years
Population: Safety analysis set of participants with both a baseline and a post-baseline ECG.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Laquinimod | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, Not CS / Normal | 5 Participants |
| Early Laquinimod | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, CS / Abnormal, CS | 0 Participants |
| Early Laquinimod | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, Not CS / Abnormal, CS | 4 Participants |
| Early Laquinimod | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, Not CS / Abnormal, Not CS | 67 Participants |
| Early Laquinimod | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Normal / Normal | 150 Participants |
| Early Laquinimod | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, CS / Abnormal, Not CS | 0 Participants |
| Early Laquinimod | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Normal / Abnormal, CS | 5 Participants |
| Early Laquinimod | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Normal / Abnormal, Not CS | 109 Participants |
| Early Laquinimod | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, CS / Normal | 0 Participants |
| Switch From Placebo | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, Not CS / Abnormal, Not CS | 62 Participants |
| Switch From Placebo | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Normal / Normal | 148 Participants |
| Switch From Placebo | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Normal / Abnormal, Not CS | 125 Participants |
| Switch From Placebo | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Normal / Abnormal, CS | 3 Participants |
| Switch From Placebo | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, Not CS / Normal | 7 Participants |
| Switch From Placebo | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, Not CS / Abnormal, CS | 0 Participants |
| Switch From Placebo | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, CS / Normal | 0 Participants |
| Switch From Placebo | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, CS / Abnormal, Not CS | 0 Participants |
| Switch From Placebo | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, CS / Abnormal, CS | 1 Participants |
| Switch From Avonex | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Normal / Abnormal, CS | 5 Participants |
| Switch From Avonex | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Normal / Normal | 134 Participants |
| Switch From Avonex | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, CS / Normal | 0 Participants |
| Switch From Avonex | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Normal / Abnormal, Not CS | 119 Participants |
| Switch From Avonex | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, CS / Abnormal, CS | 0 Participants |
| Switch From Avonex | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, Not CS / Abnormal, Not CS | 64 Participants |
| Switch From Avonex | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, Not CS / Normal | 20 Participants |
| Switch From Avonex | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, CS / Abnormal, Not CS | 1 Participants |
| Switch From Avonex | Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study | Abnormal, Not CS / Abnormal, CS | 2 Participants |
Secondary
Participants With Potentially Clinically Significant Abnormal Vital Signs
Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria: * Pulse rate: \>=120 and increase \>=30 beats/minute * Systolic blood pressure low: \<=90 and decrease \>=30 mmHg * Systolic blood pressure high: \>=180 and increase \>=30 mmHg * Diastolic blood pressure low: \<=50 and decrease \>=20 mmHg * Diastolic blood pressure high: \>=100 and increase \>=20 mmHg Note that the change is compared to baseline,
Time frame: Baseline (Day 0 for extension), Day 1 up to 7.13 years
Population: Safety analysis set of participants with a baseline and post-baseline value for that vital sign,
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Laquinimod | Participants With Potentially Clinically Significant Abnormal Vital Signs | Pulse rate - high | 2 Participants |
| Early Laquinimod | Participants With Potentially Clinically Significant Abnormal Vital Signs | Systolic blood pressure - low | 4 Participants |
| Early Laquinimod | Participants With Potentially Clinically Significant Abnormal Vital Signs | Diastolic blood pressure - high | 9 Participants |
| Early Laquinimod | Participants With Potentially Clinically Significant Abnormal Vital Signs | Participants with at least one abnormality | 19 Participants |
| Early Laquinimod | Participants With Potentially Clinically Significant Abnormal Vital Signs | Systolic blood pressure - high | 0 Participants |
| Early Laquinimod | Participants With Potentially Clinically Significant Abnormal Vital Signs | Diastolic blood pressure - low | 4 Participants |
| Switch From Placebo | Participants With Potentially Clinically Significant Abnormal Vital Signs | Systolic blood pressure - high | 2 Participants |
| Switch From Placebo | Participants With Potentially Clinically Significant Abnormal Vital Signs | Diastolic blood pressure - low | 5 Participants |
| Switch From Placebo | Participants With Potentially Clinically Significant Abnormal Vital Signs | Diastolic blood pressure - high | 10 Participants |
| Switch From Placebo | Participants With Potentially Clinically Significant Abnormal Vital Signs | Pulse rate - high | 0 Participants |
| Switch From Placebo | Participants With Potentially Clinically Significant Abnormal Vital Signs | Participants with at least one abnormality | 23 Participants |
| Switch From Placebo | Participants With Potentially Clinically Significant Abnormal Vital Signs | Systolic blood pressure - low | 7 Participants |
| Switch From Avonex | Participants With Potentially Clinically Significant Abnormal Vital Signs | Diastolic blood pressure - high | 7 Participants |
| Switch From Avonex | Participants With Potentially Clinically Significant Abnormal Vital Signs | Participants with at least one abnormality | 19 Participants |
| Switch From Avonex | Participants With Potentially Clinically Significant Abnormal Vital Signs | Pulse rate - high | 0 Participants |
| Switch From Avonex | Participants With Potentially Clinically Significant Abnormal Vital Signs | Systolic blood pressure - low | 9 Participants |
| Switch From Avonex | Participants With Potentially Clinically Significant Abnormal Vital Signs | Diastolic blood pressure - low | 4 Participants |
| Switch From Avonex | Participants With Potentially Clinically Significant Abnormal Vital Signs | Systolic blood pressure - high | 0 Participants |
Secondary
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Counts include two conditions: * a change from High / Non-PCS at baseline to Low PCS at any point during the study * a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count. ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassium
Time frame: Baseline (Day 0), Day 1 to 7.13 years
Population: Safety analysis set of participants with both a baseline and a post-baseline value for the test.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Sodium - change from High / Non-PCS to Low PCS | 4 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Phosphate-change from High / Non-PCS to Low PCS | 12 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Calcium - change from Low / Non-PCS to High PCS | 1 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | p-Amylase - change from Low / Non-PCS to High PCS | 5 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Glucose - change from Low / Non-PCS to High PCS | 4 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | CK - change from Low / Non-PCS to High PCS | 11 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Urea - change from Low / Non-PCS to High PCS | 4 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Glucose - change from High / Non-PCS to Low PCS | 12 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | CTN - change from Low / Non-PCS to High PCS | 1 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | K - change from Low / Non-PCS to High PCS | 46 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | GGT - change from Low / Non-PCS to High PCS | 16 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | FIB - change from Low / Non-PCS to High PCS | 22 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | AST - change from Low / Non-PCS to High PCS | 3 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Sodium - change from Low / Non-PCS to High PCS | 21 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | K - change from High / Non-PCS to Low PCS | 2 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Bilirubin - change from Low / Non-PCS to High PCS | 2 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | ALP - change from Low / Non-PCS to High PCS | 0 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | ALT - change from Low / Non-PCS to High PCS | 5 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | CRP - change from Low / Non-PCS to High PCS | 36 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Albumen - change from High / Non-PCS to Low PCS | 0 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Phosphate-change from Low / Non-PCS to High PCS | 17 Participants |
| Early Laquinimod | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Calcium - change from High / Non-PCS to Low PCS | 1 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Phosphate-change from Low / Non-PCS to High PCS | 18 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | ALT - change from Low / Non-PCS to High PCS | 8 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Albumen - change from High / Non-PCS to Low PCS | 1 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | ALP - change from Low / Non-PCS to High PCS | 2 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | p-Amylase - change from Low / Non-PCS to High PCS | 1 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | AST - change from Low / Non-PCS to High PCS | 2 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Bilirubin - change from Low / Non-PCS to High PCS | 3 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | CRP - change from Low / Non-PCS to High PCS | 32 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Calcium - change from High / Non-PCS to Low PCS | 1 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Calcium - change from Low / Non-PCS to High PCS | 1 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | CK - change from Low / Non-PCS to High PCS | 12 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | CTN - change from Low / Non-PCS to High PCS | 1 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | FIB - change from Low / Non-PCS to High PCS | 24 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | GGT - change from Low / Non-PCS to High PCS | 22 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Glucose - change from High / Non-PCS to Low PCS | 16 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Glucose - change from Low / Non-PCS to High PCS | 5 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Phosphate-change from High / Non-PCS to Low PCS | 12 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | K - change from High / Non-PCS to Low PCS | 4 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | K - change from Low / Non-PCS to High PCS | 39 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Sodium - change from High / Non-PCS to Low PCS | 2 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Sodium - change from Low / Non-PCS to High PCS | 16 Participants |
| Switch From Placebo | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Urea - change from Low / Non-PCS to High PCS | 4 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Glucose - change from Low / Non-PCS to High PCS | 2 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Calcium - change from High / Non-PCS to Low PCS | 1 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Albumen - change from High / Non-PCS to Low PCS | 0 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Phosphate-change from High / Non-PCS to Low PCS | 6 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | CRP - change from Low / Non-PCS to High PCS | 31 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Bilirubin - change from Low / Non-PCS to High PCS | 2 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Phosphate-change from Low / Non-PCS to High PCS | 16 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | AST - change from Low / Non-PCS to High PCS | 5 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Urea - change from Low / Non-PCS to High PCS | 3 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | K - change from High / Non-PCS to Low PCS | 2 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | p-Amylase - change from Low / Non-PCS to High PCS | 2 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Sodium - change from Low / Non-PCS to High PCS | 17 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | K - change from Low / Non-PCS to High PCS | 38 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | FIB - change from Low / Non-PCS to High PCS | 25 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | CTN - change from Low / Non-PCS to High PCS | 0 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | ALP - change from Low / Non-PCS to High PCS | 0 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | GGT - change from Low / Non-PCS to High PCS | 18 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | CK - change from Low / Non-PCS to High PCS | 10 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | ALT - change from Low / Non-PCS to High PCS | 10 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Glucose - change from High / Non-PCS to Low PCS | 11 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Calcium - change from Low / Non-PCS to High PCS | 2 Participants |
| Switch From Avonex | Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Sodium - change from High / Non-PCS to Low PCS | 3 Participants |
Secondary
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Counts include two conditions: * a change from High / Non-PCS at baseline to Low PCS at any point during the study * a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count.
Time frame: Baseline (Day 0), Day 1 to 7.13 years
Population: Safety analysis set of participants with both a baseline and a post-baseline value for the test.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Laquinimod | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Hemoglobin -change from High / Non-PCS to Low PCS | 21 Participants |
| Early Laquinimod | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Neutrophils - change from High/Non-PCS to Low PCS | 25 Participants |
| Early Laquinimod | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Leukocytes - change from Low / Non-PCS to High PCS | 4 Participants |
| Early Laquinimod | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Hematocrit - change from High / Non-PCS to Low PCS | 30 Participants |
| Early Laquinimod | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Platelets - change from Low / Non-PCS to High PCS | 4 Participants |
| Early Laquinimod | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Platelets - change from High / Non-PCS to Low PCS | 5 Participants |
| Early Laquinimod | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Leukocytes - change from High / Non-PCS to Low PCS | 2 Participants |
| Switch From Placebo | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Leukocytes - change from Low / Non-PCS to High PCS | 1 Participants |
| Switch From Placebo | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Hematocrit - change from High / Non-PCS to Low PCS | 25 Participants |
| Switch From Placebo | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Hemoglobin -change from High / Non-PCS to Low PCS | 24 Participants |
| Switch From Placebo | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Leukocytes - change from High / Non-PCS to Low PCS | 4 Participants |
| Switch From Placebo | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Neutrophils - change from High/Non-PCS to Low PCS | 12 Participants |
| Switch From Placebo | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Platelets - change from High / Non-PCS to Low PCS | 3 Participants |
| Switch From Placebo | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Platelets - change from Low / Non-PCS to High PCS | 4 Participants |
| Switch From Avonex | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Neutrophils - change from High/Non-PCS to Low PCS | 14 Participants |
| Switch From Avonex | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Hemoglobin -change from High / Non-PCS to Low PCS | 15 Participants |
| Switch From Avonex | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Platelets - change from Low / Non-PCS to High PCS | 4 Participants |
| Switch From Avonex | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Platelets - change from High / Non-PCS to Low PCS | 2 Participants |
| Switch From Avonex | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Leukocytes - change from Low / Non-PCS to High PCS | 5 Participants |
| Switch From Avonex | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Leukocytes - change from High / Non-PCS to Low PCS | 2 Participants |
| Switch From Avonex | Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study | Hematocrit - change from High / Non-PCS to Low PCS | 21 Participants |