Trial Outcomes & Findings for Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris (NCT NCT01920477)
NCT ID: NCT01920477
Last Updated: 2019-06-06
Results Overview
Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintenance of a dose \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks and maintenance of the status until Week 60.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
Baseline up to approximately 60 weeks
Results posted on
2019-06-06
Participant Flow
Sixty-nine subjects were screened.
Participant milestones
| Measure |
Ofatumumab
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
Requiried Individualized Follow-up
|
1
|
0
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
| Measure |
Ofatumumab
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Study closed/terminated
|
14
|
15
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris
Baseline characteristics by cohort
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 11.20 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/ Caucasian/ European Heritage
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 60 weeksSustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintenance of a dose \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks and maintenance of the status until Week 60.
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 60 weeksSum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day up to Week 60 was assessed.
Outcome measures
| Measure |
Ofatumumab
n=3 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=1 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Duration of Remission on Minimal Steroid Therapy
|
168.0 days
Standard Deviation 73.33
|
122.0 days
Standard Deviation NA
There is only one subject
|
SECONDARY outcome
Timeframe: Week 60Percentage of subjects who achieved absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day for \> or = 8 weeks at Week 60 was assessed. Time to remission was not estimable.
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60
|
17.6 percentage of participants
|
5.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksTime from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintained dose at \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks by Week 60 was assessed
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Time to Remission While on Minimal Steroid Therapy by Week 60.
|
NA days
Interval 57.0 to
Due to limited sample size value is not estimable
|
NA days
Due to limited sample size value is not estimable
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksPopulation: All participants remained on steroid therapy
Percentage of subjects with initial reduction of all steroids for \>=8 weeks with an absence of new or nonhealing (established) lesions by Week 60 were to be assessed. All subjects remained on prednisone/prednisolone so this endpoint could not be analyzed.Time to remission off steroid therapy also could not be analyzed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksNumber of days a subject maintained minimal steroid therapy (an oral prednisone/prednisolone dose of ≤10 mg/day in the absence of new or nonhealing lesions) by Week 60.
Outcome measures
| Measure |
Ofatumumab
n=3 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=1 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.
|
168 days
Standard Deviation 73.33
|
122.0 days
Standard Deviation NA
Only one paraticipant
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksTime from randomization to the time of appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
Outcome measures
| Measure |
Ofatumumab
n=2 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=8 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Time to Initial Flare/Relapse by Week 60
|
448 days
Due to limited sample size values are not estimable
|
169.0 days
Interval 86.0 to 284.0
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksPopulation: number of participants varied across visits
Percentage of participants achieving absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day and did not subsequently have a appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 2 no flare
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 2 no new/nonhealing lesions
|
47.1 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 4 no flare
|
88.2 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 4 no new/nonhealing lesions
|
47.1 percentage of participants
|
38.9 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 6 no flare
|
70.6 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 6 no new/nonhealing lesions
|
41.2 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 8 no flare
|
64.7 percentage of participants
|
72.2 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 8 no new/nonhealing lesions
|
35.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 12 no flare
|
58.8 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 12 no new/nonhealing lesions
|
35.3 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 16 no flare
|
52.9 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 16 no new/nonhealing lesions
|
23.5 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 20 no flare
|
47.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 20 no new/nonhealing lesions
|
29.4 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 24 no flare
|
47.1 percentage of participants
|
38.9 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 24 no new/nonhealing lesions
|
35.3 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 28 no flare
|
29.4 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 28 no new/nonhealing lesions
|
17.6 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 32 no flare
|
35.3 percentage of participants
|
27.8 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 32 no new/nonhealing lesions
|
17.6 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 36 no flare
|
23.5 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 36 no new/nonhealing lesions
|
5.9 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 40 no flare
|
17.6 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 40 no new/nonhealing lesions
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 44 no flare
|
17.6 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 44 no new/nonhealing lesions
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 48 no flare
|
17.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 48 no new/nonhealing lesions
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 52 no flare
|
11.8 percentage of participants
|
5.6 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 52 no new/nonhealing lesions
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 56 no flare
|
11.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 56 no new/nonhealing lesions
|
5.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 60 no flare
|
88.2 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With no Flare/Relapse by Week 60
Week 60 no new/nonhealing lesions
|
52.9 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: 4 hours post baseline, Days 1-4,7,14, Weeks 4,8,12,16,20,24,36,48,52,56, up to approximately 60 weeksPopulation: number of participants varied across visits
Only plasma (trough) concentrations of ofatumumab were presented
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Plasma Trough Concentrations of Ofatumumab
4 hours post dose SS
|
56.60 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Day 1 Steady State (SS)
|
1917.50 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Day 2 Steady State (SS)
|
2994.20 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Day 3 Steady State (SS)
|
3553.80 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Day 4 Steady State (SS)
|
3619.20 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Day 7 Steady State (SS)
|
3434.90 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Day 14 Steady State (SS)
|
2055.30 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 4
|
311.59 ng/mL
Standard Deviation 278.011
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 4 SS
|
1132.70 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 8
|
1253.60 ng/mL
Standard Deviation 439.574
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 8 SS
|
1456.95 ng/mL
Standard Deviation 668.994
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 12
|
727.01 ng/mL
Standard Deviation 430.834
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 12 SS
|
900.00 ng/mL
Standard Deviation 455.930
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 16
|
512.88 ng/mL
Standard Deviation 377.189
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 16 SS
|
1043.40 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 20
|
415.88 ng/mL
Standard Deviation 303.307
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 20 SS
|
720.10 ng/mL
Standard Deviation 246.356
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 24
|
461.72 ng/mL
Standard Deviation 437.717
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 24 SS
|
686.10 ng/mL
Standard Deviation 329.699
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 36
|
477.63 ng/mL
Standard Deviation 378.112
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 36 SS
|
931.20 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 48
|
352.95 ng/mL
Standard Deviation 300.591
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 48 SS
|
1230.40 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 52 SS
|
897.30 ng/mL
Standard Deviation NA
only 1 participant
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 56
|
436.40 ng/mL
Standard Deviation 511.662
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Week 60
|
76.40 ng/mL
Standard Deviation 32.244
|
—
|
|
Plasma Trough Concentrations of Ofatumumab
Early withdrawal
|
925.91 ng/mL
Standard Deviation 971.715
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksPopulation: number of participants varied across visits
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Baseline
|
1 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Week 12
|
1 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Week 16
|
—
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Week 24
|
1 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Week 36
|
1 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Week 48
|
1 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Week 52
|
1 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Week 56
|
1 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Week 60/Early withdrawal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
First 12 weeks of therapy
|
1 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
During on therapy period
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksPopulation: number of participants varied across visits
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Baseline
|
1 Participants
|
2 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Week 12
|
0 Participants
|
1 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Week 16
|
—
|
1 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Week 24
|
0 Participants
|
1 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Week 36
|
0 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Week 48
|
0 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Week 52
|
0 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Week 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Week 60/Early withdrawal
|
0 Participants
|
2 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
First 12 weeks of therapy
|
1 Participants
|
3 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
During on therapy period
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksPopulation: number of participants varied across visits
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Baseline
|
1 Participants
|
1 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Week 12
|
4 Participants
|
1 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Week 16
|
—
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Week 24
|
4 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Week 36
|
4 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Week 48
|
3 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Week 52
|
2 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Week 56
|
2 Participants
|
0 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Week 60/Early withdrawal
|
6 Participants
|
2 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
First 12 weeks of therapy
|
4 Participants
|
1 Participants
|
|
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
During on therapy period
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksPopulation: number of participants varied across visits
Immunoglobulins A, G and M were assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Largest Mean Decrease From Baseline for Immunoglobulin A, G and M
Immunoglobulin A
|
-0.185 g/L
Standard Deviation 0.1181
|
-0.472 g/L
Standard Deviation 0.7116
|
|
Largest Mean Decrease From Baseline for Immunoglobulin A, G and M
Immunoglobulin G
|
-1.172 g/L
Standard Deviation 0.9390
|
-0.955 g/L
Standard Deviation 0.6205
|
|
Largest Mean Decrease From Baseline for Immunoglobulin A, G and M
Immunoglobulin M
|
-0.231 g/L
Standard Deviation 0.1152
|
-0.263 g/L
Standard Deviation 0.3053
|
SECONDARY outcome
Timeframe: Baseline up to approximately 60 weeksPopulation: number of participants varied across visits
CD19+ B cell count will be performed using Flow Cytometry
Outcome measures
| Measure |
Ofatumumab
n=17 Participants
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 Participants
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Change From Baseline for CD19+ B Cell Count
Week 12
|
-0.24940 10^9 cells/L
Standard Deviation 0.228704
|
0.03080 10^9 cells/L
Standard Deviation 0.072358
|
|
Change From Baseline for CD19+ B Cell Count
Week 16
|
—
|
0.08000 10^9 cells/L
Standard Deviation NA
Not estimable
|
|
Change From Baseline for CD19+ B Cell Count
Week 24
|
-0.28607 10^9 cells/L
Standard Deviation 0.265327
|
-0.04022 10^9 cells/L
Standard Deviation 0.197867
|
|
Change From Baseline for CD19+ B Cell Count
Week 36
|
-0.20525 10^9 cells/L
Standard Deviation 0.052703
|
-0.10033 10^9 cells/L
Standard Deviation 0.021385
|
|
Change From Baseline for CD19+ B Cell Count
Week 48
|
-0.19717 10^9 cells/L
Standard Deviation 0.061436
|
-0.00200 10^9 cells/L
Standard Deviation NA
Not estimable
|
|
Change From Baseline for CD19+ B Cell Count
Week 52
|
-0.16300 10^9 cells/L
Standard Deviation 0.023335
|
0.09600 10^9 cells/L
Standard Deviation NA
Not estimable
|
|
Change From Baseline for CD19+ B Cell Count
Week 56
|
-0.16300 10^9 cells/L
Standard Deviation 0.023335
|
0.01000 10^9 cells/L
Standard Deviation NA
Not estimable
|
|
Change From Baseline for CD19+ B Cell Count
Week 60/Early withdrawal
|
-0.21403 10^9 cells/L
Standard Deviation 0.190282
|
0.00367 10^9 cells/L
Standard Deviation 0.190375
|
Adverse Events
Ofatumumab SC
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ofatumumab SC
n=17 participants at risk
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 participants at risk
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Investigations
Hepatic enzyme increased
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
Other adverse events
| Measure |
Ofatumumab SC
n=17 participants at risk
Subject will receive subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4.
|
Placebo
n=18 participants at risk
Subject will receive subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Ear and labyrinth disorders
Ear pain
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Eye disorders
Conjunctival discolouration
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Eye disorders
Eye irritation
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Eye disorders
Eye swelling
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Eye disorders
Ocular hyperaemia
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
General disorders
Chills
|
17.6%
3/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
General disorders
Fatigue
|
11.8%
2/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
General disorders
Influenza like illness
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
General disorders
Local reaction
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
General disorders
Malaise
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
General disorders
Pain
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
General disorders
Pyrexia
|
17.6%
3/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Folliculitis
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Influenza
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Tooth abscess
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Infections and infestations
Upper respiratory tract infection
|
11.8%
2/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Investigations
B-lymphocyte count decreased
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Psychiatric disorders
Persistent depressive disorder
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Renal and urinary disorders
Calculus urinary
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Renal and urinary disorders
Nocturia
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Reproductive system and breast disorders
Semen discolouration
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
2/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
11.1%
2/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Vascular disorders
Hot flush
|
5.9%
1/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
0.00%
0/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
5.6%
1/18 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 60 months
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER