Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (NCT NCT03277248)
NCT ID: NCT03277248
Last Updated: 2021-12-06
Results Overview
ARR is defined as the number of Independent Relapse Adjudication Committee (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
545 participants
Primary outcome timeframe
Up to 96 weeks
Results posted on
2021-12-06
Participant Flow
A total of 545 participants were enrolled across investigative sites in Belarus, Spain, the United Kingdom, Croatia, Poland, Russia, Ukraine, and the United States from 25 August 2017 to 12 November 2020.
A total of 629 participants were screened and of those, 545 were enrolled and randomized to receive either ublituximab/oral placebo or teriflunomide/IV placebo.
Participant milestones
| Measure |
Ublituximab + Oral Placebo
Participants received ublituximab intravenous (IV) infusion, 150 milligrams (mg) over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, once daily (QD) from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Overall Study
STARTED
|
272
|
273
|
|
Overall Study
COMPLETED
|
254
|
239
|
|
Overall Study
NOT COMPLETED
|
18
|
34
|
Reasons for withdrawal
| Measure |
Ublituximab + Oral Placebo
Participants received ublituximab intravenous (IV) infusion, 150 milligrams (mg) over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, once daily (QD) from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Subject Withdrawal of Consent
|
6
|
23
|
|
Overall Study
Investigator/Sponsor Decision
|
2
|
2
|
|
Overall Study
Pregnancy
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Other-Alternative Treatment//COVID-19 related/Unspecified Reasons
|
3
|
3
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Baseline characteristics by cohort
| Measure |
Ublituximab + Oral Placebo
n=272 Participants
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=273 Participants
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
Total
n=545 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 8.97 • n=7 Participants
|
35.3 years
STANDARD_DEVIATION 8.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
354 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
269 Participants
n=5 Participants
|
269 Participants
n=7 Participants
|
538 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
262 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
525 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Belarus
|
29 participants
n=5 Participants
|
35 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
78 participants
n=5 Participants
|
85 participants
n=7 Participants
|
163 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
74 participants
n=5 Participants
|
69 participants
n=7 Participants
|
143 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 96 weeksPopulation: Modified Intention-to-Treat (mITT) population consisted of all participants in the ITT population who received at least one dose of study medication and had at least one baseline and post baseline efficacy assessment.
ARR is defined as the number of Independent Relapse Adjudication Committee (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group.
Outcome measures
| Measure |
Ublituximab + Oral Placebo
n=272 Participants
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=272 Participants
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Annualized Relapse Rate (ARR)
|
0.091 relapses per participant-years
Interval 0.049 to 0.169
|
0.178 relapses per participant-years
Interval 0.109 to 0.291
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 48, and 96Population: mITT-MRI population consisted of participants in the mITT population who had a baseline and at least 1 post-baseline MRI efficacy assessments.
The total number of Gd-enhancing T1-lesions were calculated as the sum of the individual number of lesions at Weeks 12, 24, 48, and 96, divided by the total number of MRI scans of the brain.
Outcome measures
| Measure |
Ublituximab + Oral Placebo
n=272 Participants
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=267 Participants
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant
|
0.009 lesions per scan per participant
Interval 0.004 to 0.017
|
0.250 lesions per scan per participant
Interval 0.162 to 0.385
|
SECONDARY outcome
Timeframe: Weeks 24, 48, and 96Population: mITT-MRI population consisted of participants in the mITT population who had a baseline and at least 1 post-baseline MRI efficacy assessments. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
The total number of NELs were calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96, divided by the total number of MRI scans of the brain.
Outcome measures
| Measure |
Ublituximab + Oral Placebo
n=269 Participants
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=259 Participants
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant
|
0.282 lesions per scan per participant
Interval 0.2 to 0.397
|
2.831 lesions per scan per participant
Interval 2.128 to 3.767
|
SECONDARY outcome
Timeframe: Up to Week 96Population: mITT population consisted of all participants in the ITT population who received at least one dose of study medication and had at least one baseline and post baseline efficacy assessment. As per protocol, data was summarized for the mITT Population using pooled data from participants in this study and TG1101-RMS301 \[NCT03277261\].
12-week CDP is defined as an increase in EDSS at least 1 point higher than the baseline EDSS if the baseline EDSS is ≤5.5 or at least 0.5 higher than the baseline EDSS if the baseline EDSS is \>5.5. The EDSS is based on a standard neurological examination, (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, and cerebral) and ambulation function system assessments. The EDSS disability scale ranges in 0.5-point steps from 0 (normal) to 10 (death) where higher scores indicate disability. The time to onset of 12-week CDP is the time to progression to the EDSS change defined above.
Outcome measures
| Measure |
Ublituximab + Oral Placebo
n=543 Participants
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=546 Participants
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks
|
NA weeks
Median and Inter Quartile Range were not reached due to the low number of participants with events.
|
NA weeks
Median and Inter Quartile Range were not reached due to the low number of participants with events.
|
SECONDARY outcome
Timeframe: From Week 24 to Week 96Population: mITT population consisted of all participants in the ITT population who received at least one dose of study medication and had at least one baseline and post baseline efficacy assessment.
A participant with NEDA is defined as a participant without relapses confirmed by the IRAP, without MRI activities (no T1 Gd+ lesions and no new/enlarging T2 lesions), and no 12-week CDP. Any evidence of disease activity from Week 24 to Week 96 was counted as not reaching NEDA. Any evidence of disease activity before Week 24 was not counted.
Outcome measures
| Measure |
Ublituximab + Oral Placebo
n=272 Participants
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=272 Participants
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Percentage of Participants With No Evidence of Disease Activity (NEDA)
|
43.0 percentage of participants
|
11.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: mITT population consisted of all participants in the ITT population who received at least one dose of study medication and had at least one baseline and post baseline efficacy assessment.
The SDMT involves a simple substitution task using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses are done verbally. The administration time is approximately 5 minutes. The total SDMT score for each visit ranging from 0-110 is defined as the total number of correct answers reported in the case report form (CRF), where high scores indicate better outcome. Impaired SDMT is defined as a decrease of at least 4 points from baseline at any post-baseline assessment up to the Week 96 visit.
Outcome measures
| Measure |
Ublituximab + Oral Placebo
n=272 Participants
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=272 Participants
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT)
|
29.0 percentage of participants
|
31.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: mITT-MRI population consisted of participants in the mITT population who had a baseline and at least 1 post-baseline MRI efficacy assessments. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Ublituximab + Oral Placebo
n=235 Participants
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=224 Participants
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Percent Change From Baseline in Brain Volume
|
-0.194 percent change
Interval -0.225 to -0.164
|
-0.176 percent change
Interval -0.207 to -0.146
|
SECONDARY outcome
Timeframe: From the first dose of study drug through the end of the study (up to approximately 116 weeks)Population: Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is defined as any untoward medical occurrence that: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and/or causes a congenital anomaly/birth defect. TEAEs are AEs that start or worsen after receiving the study drug.
Outcome measures
| Measure |
Ublituximab + Oral Placebo
n=272 Participants
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=273 Participants
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
92.3 percentage of participants
|
93.8 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
10.3 percentage of participants
|
7.7 percentage of participants
|
Adverse Events
Ublituximab + Oral Placebo
Serious events: 28 serious events
Other events: 234 other events
Deaths: 1 deaths
Teriflunomide + IV Placebo
Serious events: 21 serious events
Other events: 233 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ublituximab + Oral Placebo
n=272 participants at risk
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=273 participants at risk
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow toxicity
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Eye disorders
Glaucoma
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Eye disorders
Astigmatism
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Eye disorders
Cataract
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
General disorders
Decreased activity
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
General disorders
Fatigue
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
General disorders
Pyrexia
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Acute sinusitis
|
1.1%
3/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.74%
2/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Pneumonia
|
0.74%
2/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.73%
2/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Appendicitis
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Chronic hepatitis B
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Complicated appendicitis
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Epididymitis
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Gastrointestinal infection
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Peritonitis
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.73%
2/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Septic shock
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoid tumour
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial stromal sarcoma
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Nervous system disorders
Coordination abnormal
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Nervous system disorders
Dysaesthesia
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.73%
2/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Nervous system disorders
Tremor
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Surgical and medical procedures
Ovarian cystectomy
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Surgical and medical procedures
Pituitary gland operation
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Vascular disorders
Deep vein thrombosis
|
0.37%
1/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.00%
0/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
Other adverse events
| Measure |
Ublituximab + Oral Placebo
n=272 participants at risk
Participants received ublituximab IV infusion, 150 mg over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, QD from Day 1 up to the last day of Week 95.
|
Teriflunomide + IV Placebo
n=273 participants at risk
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.6%
26/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.73%
2/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
9/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
5.5%
15/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Cardiac disorders
Sinus tachycardia
|
7.4%
20/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
1.8%
5/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Gastrointestinal disorders
Nausea
|
10.7%
29/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
10.3%
28/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
28/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
4.4%
12/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
25/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
11.7%
32/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Gastrointestinal disorders
Constipation
|
5.9%
16/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
6.2%
17/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
16/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
5.5%
15/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Gastrointestinal disorders
Toothache
|
5.9%
16/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
5.5%
15/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.5%
15/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
3.3%
9/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
General disorders
Pyrexia
|
12.5%
34/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
5.1%
14/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
General disorders
Influenza like illness
|
10.3%
28/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
2.6%
7/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
General disorders
Chills
|
9.2%
25/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
1.1%
3/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
General disorders
Hyperthermia
|
6.6%
18/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
1.5%
4/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
General disorders
Asthenia
|
5.9%
16/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
7.3%
20/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
General disorders
Fatigue
|
5.5%
15/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
4.0%
11/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Nasopharyngitis
|
24.6%
67/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
19.8%
54/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Respiratory tract infection
|
11.0%
30/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
10.3%
28/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Pharyngitis
|
8.8%
24/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
2.2%
6/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
24/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
9.2%
25/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Respiratory tract infection viral
|
8.1%
22/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
8.4%
23/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Cystitis
|
6.2%
17/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
4.4%
12/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Sinusitis
|
6.2%
17/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
4.8%
13/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Oral herpes
|
5.1%
14/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
5.9%
16/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Infections and infestations
Rhinitis
|
3.3%
9/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
5.1%
14/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.0%
19/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.73%
2/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Investigations
Lymphocyte count decreased
|
5.5%
15/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.73%
2/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.9%
35/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
8.4%
23/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
17/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
4.8%
13/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
16/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
4.8%
13/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Nervous system disorders
Headache
|
37.9%
103/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
31.9%
87/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Nervous system disorders
Dizziness
|
5.9%
16/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
4.4%
12/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Psychiatric disorders
Insomnia
|
7.7%
21/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
2.9%
8/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Psychiatric disorders
Anxiety
|
5.9%
16/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
4.4%
12/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.4%
12/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
5.5%
15/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
18/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
3.3%
9/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.1%
14/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
0.37%
1/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
13/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
17.6%
48/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
|
Vascular disorders
Hypertension
|
3.7%
10/272 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
5.5%
15/273 • From the first dose of study drug through the end of the study (up to approximately 116 weeks)
Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).
|
Additional Information
TG Therapeutics Clinical Support Team
TG Therapeutics
Phone: 1-877-575-8489
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place