Trial Outcomes & Findings for Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC) (NCT NCT04792567)
NCT ID: NCT04792567
Last Updated: 2024-06-20
Results Overview
Participants who had detectable SARS-CoV-2 serum functional antibodies one week after second dose of vaccine.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
At 1 week after vaccination period (defined as 1 week after second dose of vaccine)
Results posted on
2024-06-20
Participant Flow
All participants screened were enrolled, there were no screen failures.
Participant milestones
| Measure |
Siponimod - Continuous
Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination
|
Siponimod- Interrupted
Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination
|
DMT or no MS Treatment
Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
4
|
20
|
|
Overall Study
COMPLETED
|
17
|
4
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)
Baseline characteristics by cohort
| Measure |
Siponimod - Continuous
n=17 Participants
Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination
|
Siponimod- Interrupted
n=4 Participants
Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination
|
DMT or no MS Treatment
n=20 Participants
Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 5.8 • n=93 Participants
|
55.8 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
48.6 years
STANDARD_DEVIATION 12.9 • n=27 Participants
|
51.8 years
STANDARD_DEVIATION 10.2 • n=483 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
14 participants
n=93 Participants
|
3 participants
n=4 Participants
|
17 participants
n=27 Participants
|
34 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
African
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
4 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
3 participants
n=483 Participants
|
|
Multiple sclerosis diagnosis
SPMS Secondary progressive multiple sclerosis
|
14 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Multiple sclerosis diagnosis
RRMS Relapsing remitting multiple sclerosis
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Multiple sclerosis diagnosis
Active SPMS (with acute exacerbation or progression)
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Multiple sclerosis diagnosis
MS Multiple sclerosis, not specified
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Multiple sclerosis diagnosis
Active RRMS (with acute exacerbation or progression)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: At 1 week after vaccination period (defined as 1 week after second dose of vaccine)Population: Efficacy analysis set (EAS) - all participants who had a valid primary endpoint (i. e. determination of functional antibodies to SARS-CoV-2 at Week 1 after second dose of vaccine)
Participants who had detectable SARS-CoV-2 serum functional antibodies one week after second dose of vaccine.
Outcome measures
| Measure |
Siponimod - Continuous
n=17 Participants
Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination
|
Siponimod- Interrupted
n=4 Participants
Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination
|
DMT or no MS Treatment
n=20 Participants
Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination
|
|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion One Week After Receiving Second Vaccine (EAS)
|
52.9 percentage of participants
Interval 27.8 to 77.0
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
90.0 percentage of participants
Interval 68.3 to 98.8
|
SECONDARY outcome
Timeframe: Baseline; Week 1, Month 1 and Month 6 after second dose of vaccine; 1 month after booster (up to Month 12 after second dose of vaccine)Population: Safety analysis set (received any study drug) and efficacy analysis set (participants with a valid primary endpoint)
Measurement of antibody-mediated blockage (i.e. presence of functional SARS-CoV-2 antibodies) was performed to quantify functional SARS-CoV-2 neutralizing antibodies and was calculated as % inhibition to the in-assay control.
Outcome measures
| Measure |
Siponimod - Continuous
n=17 Participants
Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination
|
Siponimod- Interrupted
n=4 Participants
Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination
|
DMT or no MS Treatment
n=20 Participants
Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination
|
|---|---|---|---|
|
SARS-CoV-2 Functional Antibodies (% Inhibition) by Visits (SAF/EAS)
Screening n=17,4,20
|
-3.8 antibody titer levels (% inhibition)
Standard Deviation 5.0
|
-0.3 antibody titer levels (% inhibition)
Standard Deviation 11.1
|
-2.6 antibody titer levels (% inhibition)
Standard Deviation 8.2
|
|
SARS-CoV-2 Functional Antibodies (% Inhibition) by Visits (SAF/EAS)
Visit 1/Week 1 n=17,4,20
|
38.1 antibody titer levels (% inhibition)
Standard Deviation 34.8
|
64.0 antibody titer levels (% inhibition)
Standard Deviation 41.8
|
82.6 antibody titer levels (% inhibition)
Standard Deviation 26.7
|
|
SARS-CoV-2 Functional Antibodies (% Inhibition) by Visits (SAF/EAS)
Visit 2/Month 1 n=16,4,20
|
40.1 antibody titer levels (% inhibition)
Standard Deviation 27.2
|
87.5 antibody titer levels (% inhibition)
Standard Deviation 16.4
|
86.8 antibody titer levels (% inhibition)
Standard Deviation 21.5
|
|
SARS-CoV-2 Functional Antibodies (% Inhibition) by Visits (SAF/EAS)
Visit 3/Month 6 n=16,4,20
|
43.2 antibody titer levels (% inhibition)
Standard Deviation 32.8
|
68.3 antibody titer levels (% inhibition)
Standard Deviation 34.5
|
77.3 antibody titer levels (% inhibition)
Standard Deviation 27.1
|
|
SARS-CoV-2 Functional Antibodies (% Inhibition) by Visits (SAF/EAS)
1 Month after booster n=16,4,18
|
62.3 antibody titer levels (% inhibition)
Standard Deviation 30.3
|
96.5 antibody titer levels (% inhibition)
Standard Deviation 2.4
|
96.8 antibody titer levels (% inhibition)
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline; Week 1, Month 1 and Month 6 after second dose of vaccine; 1 month after booster (up to Month 12 after second dose of vaccine)Population: Safety analysis set (received any study drug) and efficacy analysis set (participants with a valid primary endpoint)
The release of IFNg or IL-2 after stimulation with a SARS-CoV-2/PAN corona peptide-mix measured by enzyme-linked immunosorbent spot (ELIspot) assay from peripheral blood mononuclear cells indicates the presence of SARS-CoV-2 reactive T-cells, i.e. a T-cell response.
Outcome measures
| Measure |
Siponimod - Continuous
n=17 Participants
Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination
|
Siponimod- Interrupted
n=4 Participants
Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination
|
DMT or no MS Treatment
n=20 Participants
Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination
|
|---|---|---|---|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Screening reactive n=17,4,20
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Screening not reactive n=17,4,20
|
10 participants
|
3 participants
|
19 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Screening missing value n=17,4,20
|
7 participants
|
1 participants
|
0 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 1/Week 1 reactive n=17,4,20
|
7 participants
|
3 participants
|
12 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 1/Week 1 not reactive n=17,4,20
|
8 participants
|
1 participants
|
8 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 1/Week 1 missing value n=17,4,20
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 2/Month 1 reactive n=16,4,20
|
0 participants
|
1 participants
|
14 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 2/Month 1 not reactive n=16,4,20
|
16 participants
|
3 participants
|
6 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 2/Month 1 missing value n=16,4,20
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 3/Month 6 reactive n=17,4,20
|
4 participants
|
1 participants
|
14 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 3/Month 6 not reactive n=17,4,20
|
11 participants
|
3 participants
|
5 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 3/Month 6 missing value n=17,4,20
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 1 Month after booster reactive n=16,4,18
|
4 participants
|
2 participants
|
15 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 1 Month after booster not reactive n=16,4,18
|
10 participants
|
2 participants
|
3 participants
|
|
Number of Patients Reactive to INFg or IL-2 SARS-CoV-2 by Visit SAF/EAS
Visit 1 Month after booster missing value n=16,4,18
|
2 participants
|
0 participants
|
0 participants
|
Adverse Events
Siponimod Continuous
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Siponimod Interrupted
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
DMT or No MS Treatment
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Siponimod Continuous
n=17 participants at risk
Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination
|
Siponimod Interrupted
n=4 participants at risk
Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination
|
DMT or No MS Treatment
n=20 participants at risk
Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination
|
|---|---|---|---|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Infections and infestations
Escherichia urinary tract infection
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
Other adverse events
| Measure |
Siponimod Continuous
n=17 participants at risk
Continuous treatment with siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) during SARS-CoV-2 mRNA vaccination
|
Siponimod Interrupted
n=4 participants at risk
Siponimod (oral, daily, dose depending on CYP2C9 genotype: 2mg or 1 mg) with treatment interruption (for approx. 2-3 months) for the purpose of a SARS-CoV-2 mRNA vaccination
|
DMT or No MS Treatment
n=20 participants at risk
Baseline disease modifying treatments (DMTs) or no multiple sclerosis treatment during SARS-CoV-2 mRNA vaccination
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
17.6%
3/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Eye disorders
Visual impairment
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
General disorders
Chills
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
General disorders
Fatigue
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
10.0%
2/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
General disorders
Influenza like illness
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
10.0%
2/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
General disorders
Injection site erythema
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
General disorders
Injection site pain
|
17.6%
3/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
10.0%
2/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
General disorders
Peripheral swelling
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Hepatobiliary disorders
Primary biliary cholangitis
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Infections and infestations
COVID-19
|
23.5%
4/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
5/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Infections and infestations
Herpes zoster reactivation
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Infections and infestations
Injection site pustule
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Infections and infestations
Rhinitis
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Investigations
Blood pressure increased
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Investigations
Body temperature increased
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Investigations
Liver function test increased
|
11.8%
2/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.8%
2/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
10.0%
2/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Nervous system disorders
Band sensation
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
10.0%
2/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
11.8%
2/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
5.0%
1/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Nervous system disorders
VIth nerve paralysis
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Psychiatric disorders
Depression
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Vascular disorders
Flushing
|
5.9%
1/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
25.0%
1/4 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
0.00%
0/20 • Adverse events were reported from screening visit for a maximum of 69 weeks.
The signing of the Informed Consent was considered the start of treatment for this trial because participants entered the trial on treatment as part of their clinical routine.
|
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