Trial Outcomes & Findings for Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab (NCT NCT03249714)
NCT ID: NCT03249714
Last Updated: 2022-04-29
Results Overview
Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, and subgroup of baseline number of Gd-enhancing T1 lesions (0 or \>=1) as explanatory variables, and logarithm of the patient's number of scans as the offset variable.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Baseline up to Week 24
Results posted on
2022-04-29
Participant Flow
Patients where randomized in a 2:1 ratio to ofatumumab or placebo in the Core Part
Participant milestones
| Measure |
OMB 20 mg
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks
|
Placebo - OMB 20 mg
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
|
|---|---|---|
|
Double-blind Treatment (Core Part)
STARTED
|
43
|
21
|
|
Double-blind Treatment (Core Part)
COMPLETED
|
40
|
19
|
|
Double-blind Treatment (Core Part)
NOT COMPLETED
|
3
|
2
|
|
Open-label Treatment (Extension Part)
STARTED
|
40
|
19
|
|
Open-label Treatment (Extension Part)
COMPLETED
|
38
|
19
|
|
Open-label Treatment (Extension Part)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
OMB 20 mg
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks
|
Placebo - OMB 20 mg
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
|
|---|---|---|
|
Double-blind Treatment (Core Part)
Lack of Efficacy
|
1
|
1
|
|
Double-blind Treatment (Core Part)
Subject/guardian decision
|
1
|
1
|
|
Double-blind Treatment (Core Part)
Lost to Follow-up
|
1
|
0
|
|
Open-label Treatment (Extension Part)
Adverse Event
|
2
|
0
|
Baseline Characteristics
n=number of participants with non-missing values
Baseline characteristics by cohort
| Measure |
OMB 20 mg
n=43 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks
|
Placebo
n=21 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter. EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.0 years
STANDARD_DEVIATION 9.49 • n=43 Participants
|
35.5 years
STANDARD_DEVIATION 8.93 • n=21 Participants
|
35.2 years
STANDARD_DEVIATION 9.24 • n=64 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=43 Participants
|
19 Participants
n=21 Participants
|
55 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=43 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Asian
|
21 Participants
n=43 Participants
|
11 Participants
n=21 Participants
|
32 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=43 Participants
|
10 Participants
n=21 Participants
|
32 Participants
n=64 Participants
|
|
Country of Enrollment
Japan
|
21 Participants
n=43 Participants
|
11 Participants
n=21 Participants
|
32 Participants
n=64 Participants
|
|
Country of Enrollment
Russia
|
22 Participants
n=43 Participants
|
10 Participants
n=21 Participants
|
32 Participants
n=64 Participants
|
|
Number of relapses in the past 12 months prior to screening
|
1.6 Number of relapses
STANDARD_DEVIATION 0.90 • n=43 Participants
|
1.2 Number of relapses
STANDARD_DEVIATION 0.70 • n=21 Participants
|
1.5 Number of relapses
STANDARD_DEVIATION 0.85 • n=64 Participants
|
|
Number of Gd-enhancing T1 lesions
|
1.3 lesions
STANDARD_DEVIATION 2.62 • n=42 Participants • n=number of participants with non-missing values
|
1.0 lesions
STANDARD_DEVIATION 1.47 • n=21 Participants • n=number of participants with non-missing values
|
1.2 lesions
STANDARD_DEVIATION 2.29 • n=63 Participants • n=number of participants with non-missing values
|
PRIMARY outcome
Timeframe: Baseline up to Week 24Population: Full analysis set (participants with missing baseline or post-baseline MRI data could not be included in the analysis)
Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, and subgroup of baseline number of Gd-enhancing T1 lesions (0 or \>=1) as explanatory variables, and logarithm of the patient's number of scans as the offset variable.
Outcome measures
| Measure |
OMB 20 mg
n=39 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=20 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part
|
0.0670 lesions per scan
Interval 0.027 to 0.167
|
1.0413 lesions per scan
Interval 0.465 to 2.331
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: Full analysis set (participants with missing baseline or post-baseline MRI data could not be included in the analysis)
Total number of Gd-enhancing T1 lesions across scans at Week 12, 16, 20, and 24 were adjusted for the different numbers of scans. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log link. The model included each patient's total number of Gd-enhancing T1 lesions as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or \>=1), and the treatment-by-region interaction term as explanatory variables, and the patient's number of scans as the offset variable.
Outcome measures
| Measure |
OMB 20 mg
n=19 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=10 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
n=20 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
n=10 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part
|
0.1999 lesions per scan
Interval 0.082 to 0.485
|
1.4682 lesions per scan
Interval 0.538 to 4.004
|
0.0000 lesions per scan
Interval 0.0 to 0.0
|
0.6774 lesions per scan
Interval 0.234 to 1.962
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: Full analysis set (participants with missing baseline or post-baseline MRI data could not be included in the analysis)
Number of new/enlarging T2 lesions on the last available MRI scan in the Core Part (up to Week 24) relative to baseline, adjusted for different follow-up times. This was calculated as a rate for population, rather than at patient level, using a negative binomial regression model with log-link. The model included each patient's last available number of new or enlarging T2 lesions relative to baseline as the response variable, and treatment, region, subgroup of baseline number of Gd-enhancing T1 lesions (0 or \>=1), and baseline volume of T2 lesions as explanatory variables, and the patient's follow-up time as the offset variable.
Outcome measures
| Measure |
OMB 20 mg
n=40 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=20 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part
|
3.7344 T2 lesions per year
Interval 2.354 to 5.925
|
13.1533 T2 lesions per year
Interval 7.197 to 24.039
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: Full analysis set
ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR was calculated as a rate for population, rather than at patient-level, using a negative binomial regression model with log-link. The model included each patient's number of confirmed relapses as the response variable, and treatment and region as explanatory variables, and the patient's follow-up time as the offset variable.
Outcome measures
| Measure |
OMB 20 mg
n=43 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=21 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Annualized Relapse Rate (ARR) - Core Part
|
0.2640 relapses in a year
Interval 0.111 to 0.629
|
0.6286 relapses in a year
Interval 0.276 to 1.43
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose at Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24Population: Full analysis set
Blood samples were collected at the scheduled visit. Summary statistics of PK concentrations from trough samples.
Outcome measures
| Measure |
OMB 20 mg
n=21 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=22 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
n=43 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
Baseline n=21,22,43
|
0.03 ug/mL
Standard Deviation 0.07
|
0.9 ug/mL
Standard Deviation .39
|
.06 ug/mL
Standard Deviation .28
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
Day 2 n=21,22,43
|
.43 ug/mL
Standard Deviation .38
|
.24 ug/mL
Standard Deviation .32
|
0.33 ug/mL
Standard Deviation .36
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
Day 5 n=21,22,43
|
.88 ug/mL
Standard Deviation .40
|
.60 ug/mL
Standard Deviation .46
|
.73 ug/mL
Standard Deviation .45
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
Day 7 n=21,22,43
|
.84 ug/mL
Standard Deviation .39
|
0.48 ug/mL
Standard Deviation .34
|
0.66 ug/mL
Standard Deviation .40
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
Day 14 n=21,22,43
|
2.17 ug/mL
Standard Deviation .63
|
1.71 ug/mL
Standard Deviation 1.00
|
1.93 ug/mL
Standard Deviation .86
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
Week 4 n=21,22,43
|
2.69 ug/mL
Standard Deviation .86
|
2.03 ug/mL
Standard Deviation 1.14
|
2.35 ug/mL
Standard Deviation 1.05
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
Week 12 n=20,21,41
|
.66 ug/mL
Standard Deviation .62
|
0.38 ug/mL
Standard Deviation .38
|
.51 ug/mL
Standard Deviation .53
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part
Week 24 n=20,20,40
|
.84 ug/mL
Standard Deviation .60
|
.64 ug/mL
Standard Deviation .46
|
.74 ug/mL
Standard Deviation .54
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 5, 7, 14, Weeks 4, 12, 24Population: Safety set
Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.
Outcome measures
| Measure |
OMB 20 mg
n=21 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=11 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
n=22 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
n=10 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
B-cell Counts - Japan vs Non-Japan - Core Part
Day 7 n=21,11,22,9
|
3.0 cells/uL
Interval 0.0 to 21.0
|
209.0 cells/uL
Interval 61.0 to 514.0
|
3.5 cells/uL
Interval 0.0 to 37.0
|
228.0 cells/uL
Interval 15.0 to 319.0
|
|
B-cell Counts - Japan vs Non-Japan - Core Part
Day 14 n=21,11,19,8
|
2 cells/uL
Interval 0.0 to 24.0
|
266.0 cells/uL
Interval 82.0 to 496.0
|
3.0 cells/uL
Interval 0.0 to 19.0
|
226.0 cells/uL
Interval 132.0 to 323.0
|
|
B-cell Counts - Japan vs Non-Japan - Core Part
Week 4 n=21,10,21,8
|
1.0 cells/uL
Interval 0.0 to 19.0
|
235.5 cells/uL
Interval 178.0 to 489.0
|
1.0 cells/uL
Interval 0.0 to 7.0
|
179.5 cells/uL
Interval 15.0 to 353.0
|
|
B-cell Counts - Japan vs Non-Japan - Core Part
Week 12 n=20,10,18,9
|
1.0 cells/uL
Interval 0.0 to 8.0
|
211.0 cells/uL
Interval 130.0 to 464.0
|
1.0 cells/uL
Interval 0.0 to 8.0
|
200.0 cells/uL
Interval 59.0 to 316.0
|
|
B-cell Counts - Japan vs Non-Japan - Core Part
Week 24 n=19,8,19,8
|
0.0 cells/uL
Interval 0.0 to 4.0
|
227.5 cells/uL
Interval 79.0 to 462.0
|
1.0 cells/uL
Interval 0.0 to 15.0
|
224.5 cells/uL
Interval 106.0 to 523.0
|
|
B-cell Counts - Japan vs Non-Japan - Core Part
Baseline n=21,11,22,9
|
207 cells/uL
Interval 41.0 to 566.0
|
205 cells/uL
Interval 81.0 to 814.0
|
208 cells/uL
Interval 78.0 to 419.0
|
244 cells/uL
Interval 81.0 to 385.0
|
|
B-cell Counts - Japan vs Non-Japan - Core Part
Day 2 n=21,11,21,9
|
3.0 cells/uL
Interval 1.0 to 69.0
|
319.0 cells/uL
Interval 127.0 to 629.0
|
14.0 cells/uL
Interval 1.0 to 283.0
|
292.0 cells/uL
Interval 79.0 to 797.0
|
|
B-cell Counts - Japan vs Non-Japan - Core Part
Day 5 n=20,10,14,7
|
3.0 cells/uL
Interval 1.0 to 50.0
|
216.5 cells/uL
Interval 91.0 to 658.0
|
8.5 cells/uL
Interval 0.0 to 300.0
|
257.0 cells/uL
Interval 124.0 to 533.0
|
SECONDARY outcome
Timeframe: Week 24 up to Week 48Population: Extension full analysis set
Total number of Gd-enhancing T1 lesions per scan during the Extension Part (up to Week 48) calculated as a rate for population, rather than at patient-level. It was calculated as sum of each patient's total number of Gd-enhancing T1 lesions across scans at Week 36 and 48, divided by sum of each patient's total number of scans.
Outcome measures
| Measure |
OMB 20 mg
n=38 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=19 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Extension Part
|
0.027 lesions per scan
|
0.025 lesions per scan
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 up to Week 48Population: Extension full analysis set
Number of new/enlarging T2 lesions on the last available MRI scan in the Extension Part (up to Week 48) relative to Week 24, adjusted for different follow-up times. Annualized rate of new or enlarging T2 lesions was calculated by dividing the sum of each patient's number of new or enlarging T2 lesions relative to Week 24 by the sum of each patient's number of MRI assessment days during the Extension part, and then multiplying it by 365.25.
Outcome measures
| Measure |
OMB 20 mg
n=40 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=19 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Extension Part
|
0.230 T2 lesions per year
|
0.813 T2 lesions per year
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 up to Week 48Population: Extension full analysis set
ARR was the number of confirmed MS relapses in a year. A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). ARR (time-based) was calculated by summing each patient's number of confirmed relapses observed during the Extension part, divided by the total number of each patient's days in a study of all patients during the Extension part, and multiplied by 365.25.
Outcome measures
| Measure |
OMB 20 mg
n=40 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=19 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Annualized Relapse Rate (ARR) - Extension Part
|
0.081 relapses in a year
|
0.083 relapses in a year
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 28, 36, 48Population: Extension full analysis set
Blood samples were collected at the scheduled visits. Summary statistics of PK concentrations from trough samples.
Outcome measures
| Measure |
OMB 20 mg
n=20 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=20 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part
Week 24
|
.84 ug/mL
Standard Deviation .60
|
.64 ug/mL
Standard Deviation .46
|
—
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part
Week 28 n=19,19
|
0.64 ug/mL
Standard Deviation .36
|
.61 ug/mL
Standard Deviation .48
|
—
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part
Week 36 n=19,19
|
.97 ug/mL
Standard Deviation .53
|
.72 ug/mL
Standard Deviation .56
|
—
|
—
|
|
Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part
Week 48 n=18,19
|
1.11 ug/mL
Standard Deviation .56
|
.94 ug/mL
Standard Deviation .76
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36 and 48Population: Extension safety set
Blood samples were collected at the scheduled visits. The CD19+ B-cell counts were measured by the central laboratory.
Outcome measures
| Measure |
OMB 20 mg
n=40 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=19 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
B-cell Counts - Extension Part
Week 24 n=40,18
|
0.0 cells/uL
Interval 0.0 to 15.0
|
1.0 cells/uL
Interval 0.0 to 5.0
|
—
|
—
|
|
B-cell Counts - Extension Part
Week 36 n=38, 9
|
0.5 cells/uL
Interval 0.0 to 4.0
|
1.0 cells/uL
Interval 0.0 to 2.0
|
—
|
—
|
|
B-cell Counts - Extension Part
Week 48 n=38,1
|
1.0 cells/uL
Interval 0.0 to 4.0
|
4.0 cells/uL
Interval 4.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: Extension full analysis set
A confirmed MS relapse was defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system).
Outcome measures
| Measure |
OMB 20 mg
n=40 Participants
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
Placebo
n=19 Participants
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter.
|
OMB 20 mg Non-Japan
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
\- non-Japanese patients
|
Placebo Non-Japan
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter - non-Japanese patients
|
|---|---|---|---|---|
|
Participants With Confirmed Relapse - Core and Extension Parts
Day 1 to Week 12
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Participants With Confirmed Relapse - Core and Extension Parts
>Week 12 to Week 24
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Participants With Confirmed Relapse - Core and Extension Parts
>Week 24 to Week 36
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Participants With Confirmed Relapse - Core and Extension Parts
>Week 36 to Week 48
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
OMB 20mg Core
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo Core
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
OMB 20mg Continued
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
OMB 20mg Switched (From Placebo)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OMB 20mg Core
n=43 participants at risk
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
|
Placebo Core
n=21 participants at risk
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
|
OMB 20mg Continued
n=40 participants at risk
EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks
|
OMB 20mg Switched (From Placebo)
n=19 participants at risk
EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
2.5%
1/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
Other adverse events
| Measure |
OMB 20mg Core
n=43 participants at risk
CORE PART: Ofatumumab 20 mg s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
|
Placebo Core
n=21 participants at risk
CORE PART: Placebo s.c. injections on Days 1, 7, 14, Week 4 and every 4 weeks thereafter
|
OMB 20mg Continued
n=40 participants at risk
EXTENSION PART: Ofatumumab 20 mg s.c. injections every 4 weeks
|
OMB 20mg Switched (From Placebo)
n=19 participants at risk
EXTENSION PART: Ofatumumab 20 mg s.c. injections at Week 24, Week 25, Week 26 and every 4 weeks thereafter
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
10.5%
2/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
14.3%
3/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
2.5%
1/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
9.5%
2/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.0%
2/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
4.8%
1/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.0%
2/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.0%
2/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
2.5%
1/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
General disorders
Injection site reaction
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
9.5%
2/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.0%
2/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
General disorders
Physical deconditioning
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Infections and infestations
Bronchitis
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
2.5%
1/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Infections and infestations
Influenza
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
4.8%
1/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.0%
2/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
6/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
19.0%
4/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
17.5%
7/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
21.1%
4/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Infections and infestations
Oral herpes
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.0%
2/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Infections and infestations
Rhinitis
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
2.5%
1/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Infections and infestations
Varicella
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Injury, poisoning and procedural complications
Contusion
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
20.9%
9/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
19.0%
4/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
2.5%
1/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
21.1%
4/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
4.8%
1/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.0%
2/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Investigations
Glucose urine present
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Investigations
Weight increased
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
3/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
4.8%
1/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
9.5%
2/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Nervous system disorders
Headache
|
4.7%
2/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
4.8%
1/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
2.5%
1/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Nervous system disorders
Tension headache
|
9.3%
4/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
14.3%
3/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.0%
2/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
14.3%
3/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
2.5%
1/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
5.3%
1/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/21 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
7.5%
3/40 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
0.00%
0/19 • Adverse events were reported from first dose of study treatment until last administration of study treatment plus 100 days post treatment, up to maximum duration of approximately 638 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER