Trial Outcomes & Findings for A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis (NCT NCT02038049)
NCT ID: NCT02038049
Last Updated: 2021-01-05
Results Overview
The effect of VAY736, compared to placebo on the cumulative number of new gadolinium \[Gd\]-enhancing lesions on T1-weighted brain MRI scans in relapsing-remitting multiple sclerosis (RRMS) patient population at weeks 8, 12 and 16. Only descriptive statistics performed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Week 8, Week 12, Week 16
Results posted on
2021-01-05
Participant Flow
This study was conducted in 5 centers in 3 countries: Czech Republic (1), Ukraine (2 sites) and USA (2 sites).
The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.
Participant milestones
| Measure |
VAY736
Intravenous infusion of VAY736
|
Placebo to VAY736
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
Pharmacodynamic (PD) Analysis Set
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
VAY736
Intravenous infusion of VAY736
|
Placebo to VAY736
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
VAY736
n=4 Participants
Intravenous infusion of VAY736
|
Placebo to VAY736
n=4 Participants
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.0 Years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
42.0 Years
STANDARD_DEVIATION 2.45 • n=7 Participants
|
37.0 Years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8, Week 12, Week 16Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
The effect of VAY736, compared to placebo on the cumulative number of new gadolinium \[Gd\]-enhancing lesions on T1-weighted brain MRI scans in relapsing-remitting multiple sclerosis (RRMS) patient population at weeks 8, 12 and 16. Only descriptive statistics performed.
Outcome measures
| Measure |
VAY736
n=4 Participants
Intravenous infusion of VAY736
|
Placebo to VAY736
n=4 Participants
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
Placebo Administered at Visit 2
Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|---|
|
Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16
Week 16
|
6 Lesions
|
3 Lesions
|
—
|
|
Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16
Week 8
|
5 Lesions
|
1 Lesions
|
—
|
|
Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16
Week12
|
5 Lesions
|
2 Lesions
|
—
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Outcome measures
| Measure |
VAY736
n=4 Participants
Intravenous infusion of VAY736
|
Placebo to VAY736
n=4 Participants
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
Placebo Administered at Visit 2
Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|---|
|
Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 4
|
19 Lesions
|
2 Lesions
|
—
|
|
Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 8
|
20 Lesions
|
2 Lesions
|
—
|
|
Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 12
|
20 Lesions
|
3 Lesions
|
—
|
|
Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 16
|
21 Lesions
|
4 Lesions
|
—
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all new T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Outcome measures
| Measure |
VAY736
n=4 Participants
Intravenous infusion of VAY736
|
Placebo to VAY736
n=4 Participants
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
Placebo Administered at Visit 2
Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|---|
|
Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 4
|
4 Lesions
|
1 Lesions
|
—
|
|
Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 8
|
1 Lesions
|
0 Lesions
|
—
|
|
Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 12
|
0 Lesions
|
1 Lesions
|
—
|
|
Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 16
|
1 Lesions
|
1 Lesions
|
—
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 hyperintense lesions (new or enlarging T2-weighted lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Outcome measures
| Measure |
VAY736
n=4 Participants
Intravenous infusion of VAY736
|
Placebo to VAY736
n=4 Participants
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
Placebo Administered at Visit 2
Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|---|
|
Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 4
|
279 Lesions
|
94 Lesions
|
—
|
|
Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 8
|
277 Lesions
|
93 Lesions
|
—
|
|
Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 12
|
276 Lesions
|
91 Lesions
|
—
|
|
Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16
Week 16
|
264 Lesions
|
91 Lesions
|
—
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 burden of disease. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Outcome measures
| Measure |
VAY736
n=4 Participants
Intravenous infusion of VAY736
|
Placebo to VAY736
n=4 Participants
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
Placebo Administered at Visit 2
Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|---|
|
T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16.
Week 4
|
20108.9 mm3 of T2-weighted lesions
|
17706 mm3 of T2-weighted lesions
|
—
|
|
T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16.
Week 8
|
18998.9 mm3 of T2-weighted lesions
|
16785 mm3 of T2-weighted lesions
|
—
|
|
T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16.
Week 12
|
18484.1 mm3 of T2-weighted lesions
|
15996 mm3 of T2-weighted lesions
|
—
|
|
T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16.
Week 16
|
18102.7 mm3 of T2-weighted lesions
|
17919 mm3 of T2-weighted lesions
|
—
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess patients without any new MRI disease activity (no new Gd-enhancing lesions nor new or enlarging T2 lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.
Outcome measures
| Measure |
VAY736
n=4 Participants
Intravenous infusion of VAY736
|
Placebo to VAY736
n=4 Participants
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
Placebo Administered at Visit 2
Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|---|
|
Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16.
Week 16
|
3 Participants
|
3 Participants
|
—
|
|
Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16.
Week 4
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16.
Week 8
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16.
Week 12
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Day 1), Week 4, Week 8, Week 12, Week 16Population: Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered
A relapse is defined as the appearance of a new neurological abnormality, or worsening of previously stable, or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\<37.5 C) or infection. A relapse was considered confirmed when confirmed by an Extended disability status scale (EDSS)-certified physician who was not involved in the treatment of the patient, was blinded to treatment allocation, and had no access to patient medical records. It was recommended that this occurs within 5 days of the onset of symptoms. A relapse was confirmed when it was accompanied by an increase of at least half a point (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Only descriptive statistics performed.
Outcome measures
| Measure |
VAY736
n=4 Participants
Intravenous infusion of VAY736
|
Placebo to VAY736
n=4 Participants
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
Placebo Administered at Visit 2
Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|---|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 0 (Day 1) · Relapse-free
|
4 Participants
|
4 Participants
|
—
|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 0 (Day 1) · Relapse
|
0 Participants
|
0 Participants
|
—
|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 4 · Relapse-free
|
4 Participants
|
4 Participants
|
—
|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 4 · Relapse
|
0 Participants
|
0 Participants
|
—
|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 8 · Relapse-free
|
4 Participants
|
4 Participants
|
—
|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 8 · Relapse
|
0 Participants
|
0 Participants
|
—
|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 12 · Relapse-free
|
4 Participants
|
4 Participants
|
—
|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 12 · Relapse
|
0 Participants
|
0 Participants
|
—
|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 16 · Relapse-free
|
3 Participants
|
3 Participants
|
—
|
|
Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.
Week 16 · Relapse
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216)Population: The Safety Set, which consisted of all patients who received at least one dose of study drug during the treatment period, was considered
Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that VAY736 is safe for the treatment of patients with relapsing-remitting multiple sclerosis through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive statistics performed.
Outcome measures
| Measure |
VAY736
n=4 Participants
Intravenous infusion of VAY736
|
Placebo to VAY736
n=4 Participants
Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
Placebo Administered at Visit 2
n=4 Participants
Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|---|
|
Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death
On-treatment Adverse Events (AEs)
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death
On-treatment Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death
On-treatment Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
VAY736 Administered at Visit 2 (Day 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
VAY736 Administered at Visit 7 (Week 16 - Week 17)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Administered at Visit 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VAY736 Administered at Visit 2 (Day 1)
n=4 participants at risk
Intravenous infusion of VAY736 at Visit 2 (Day 1)
|
VAY736 Administered at Visit 7 (Week 16 - Week 17)
n=4 participants at risk
Intravenous infusion of VAY736 at Visit 7 (Week 16 - Week 17)
|
Placebo Administered at Visit 2
n=4 participants at risk
Matching placebo (infusion bag) administered intravenously at Visit 2. Placebo randomized patients were offered optional VAY736 administration after week 16.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Cardiac disorders
Tachycardia
|
75.0%
3/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
General disorders
Asthenia
|
50.0%
2/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
General disorders
Chills
|
50.0%
2/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
General disorders
Hyperthermia
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Infections and infestations
Respiratory tract infection viral
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Investigations
Glucose urine present
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Nervous system disorders
Headache
|
75.0%
3/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Nervous system disorders
Hypotonia
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
0.00%
0/4 • Adverse events and serious adverse events were collected from first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216).
|
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