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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002324-16 | EudraCT Number |
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The study recruitment was terminated based on strategic considerations after 8 patients were enrolled.
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This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).
The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAY736 | Experimental | Intravenous infusion of VAY736 |
|
| Placebo to VAY736 | Placebo Comparator | Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAY736 | Drug | Single intravenous infusion of VAY736 (10 mg/kg) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 | 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. | Week 8, Week 12, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | 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. | Week 4, Week 8, Week 12, Week 16 |
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Key inclusion criteria:
Male and female patients aged 18 to 55 years.
Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman et al 2011).
A relapsing-remitting course of disease with:
An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening.
No evidence of a relapse within 30 days prior to randomization.
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Long Beach | California | 90806 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.
This study was conducted in 5 centers in 3 countries: Czech Republic (1), Ukraine (2 sites) and USA (2 sites).
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| ID | Title | Description |
|---|---|---|
| FG000 | VAY736 | Intravenous infusion of VAY736 |
| FG001 | Placebo to VAY736 | Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo to VAY736 |
|
| Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | 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. | Week 4, Week 8, Week 12, Week 16 |
| Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | 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. | Week 4, Week 8, Week 12, Week 16 |
| T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | 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. | Week 4, Week 8, Week 12, Week 16 |
| Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | 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. | Week 4, Week 8, Week 12, Week 16 |
| Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | 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. | Week 0 (Day 1), Week 4, Week 8, Week 12, Week 16 |
| Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | 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. | 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) |
| San Diego |
| California |
| 92103 |
| United States |
| Novartis Investigative Site | Hradec Králové | 501 03 | Czechia |
| Novartis Investigative Site | Kharkiv | 61068 | Ukraine |
| Novartis Investigative Site | Lviv | 79010 | Ukraine |
|
| Pharmacodynamic (PD) Analysis Set | At least one dose of study drug and one evaluable PD assessment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | VAY736 | Intravenous infusion of VAY736 |
| BG001 | Placebo to VAY736 | Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16 | 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. | 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 | Posted | Number | Lesions | Week 8, Week 12, Week 16 |
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| Secondary | Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | 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. | 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 | Posted | Number | Lesions | Week 4, Week 8, Week 12, Week 16 |
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| Secondary | Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | 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. | 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 | Posted | Number | Lesions | Week 4, Week 8, Week 12, Week 16 |
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| Secondary | Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16 | 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. | 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 | Posted | Number | Lesions | Week 4, Week 8, Week 12, Week 16 |
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| Secondary | T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16. | 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. | 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 | Posted | Number | mm3 of T2-weighted lesions | Week 4, Week 8, Week 12, Week 16 |
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| Secondary | Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16. | 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. | 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 | Posted | Number | Participants | Week 4, Week 8, Week 12, Week 16 |
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| Secondary | Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period. | 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. | 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 | Posted | Count of Participants | Participants | Week 0 (Day 1), Week 4, Week 8, Week 12, Week 16 |
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| Secondary | Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death | 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. | The Safety Set, which consisted of all patients who received at least one dose of study drug during the treatment period, was considered | Posted | Count of Participants | Participants | 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) |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VAY736 Administered at Visit 2 (Day 1) | Intravenous infusion of VAY736 at Visit 2 (Day 1) | 0 | 4 | 0 | 4 | 4 | 4 |
| EG001 | VAY736 Administered at Visit 7 (Week 16 - Week 17) | Intravenous infusion of VAY736 at Visit 7 (Week 16 - Week 17) | 0 | 4 | 0 | 4 | 3 | 4 |
| EG002 | 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. | 0 | 4 | 0 | 4 | 1 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
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| Glucose urine present | Investigations | MedDRA (21.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| Hypotonia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
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After enrolling 8 patients, the recruitment was terminated based on strategic considerations.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000656267 | ianalumab |
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| Male |
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| Other |
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| Week 16 |
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