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The purpose of this study was to evaluate the efficacy and safety of ofatumumab s.c. in adult participants with relapsing multiple sclerosis (RMS) in China.
This study consisted of three periods, Screening (up to 30 days), Treatment (12 months) and Post-treatment follow-up (6 months). It was an open-label single-arm study so all participants received the study drug. The first dose was administered in the clinic and the remaining doses were administered at home. The doses were administered at Baseline/Week 0, Week 1, Week 2, and followed by subsequent monthly dosing starting at Week 4.
Participants were required to come into the clinic for one screening visit, and 5 visits during the Treatment period for clinical evaluation and lab tests. Participants who completed the 12-month treatment had Post treatment Follow-Up visits at End of Study plus 3 months (EOS + 3M) and EOS + 6M, unless the participants decided to continue with commercially available ofatumumab treatment outside of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofatumumab | Experimental | Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Biological | Solution for injection in an autoinjector (pre-filled pen) containing 20 mg ofatumumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Annualized Relapse Rate (ARR) Based on Confirmed Relapses | A confirmed MS relapse is defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). Adjusted ARR was obtained from fitting a negative binomial regression model adjusted for number of relapses in the previous year, baseline number of T1 Gd-enhancing lesions and baseline age as continuous covariates (offset: Natural log of time in study in years). | Baseline up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events and Serious Adverse Events | Adverse events and SAEs, including clinically significant laboratory data and vital signs which meet the definition of adverse events | Baseline to safety cut-off up to approximately 15.2 months |
| Number of Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Based Annualized Relapse Rate (ARR) | A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (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). Participant-based ARR was calculated by taking the total number of relapses observed for a participant divided by the total number of days in study of that participant and multiplied by 365.25. |
Inclusion Criteria:
Male or female Chinese aged 18-55 years (inclusive) at their enrollment of the study (signing the study consent form).
Clinical definite diagnosis of RMS according to the 2017 Revised McDonald criteria (Thompson et al 2018, and the documentation prior to their enrollment to the study (signing the study consent form) of:
Disability status with an EDSS score of 0 - 5.5 (inclusive) at Screening.
Neurologically stable within 1 month prior to both Screening and Baseline (including no MS relapse in this period).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Lanzhou | Gansu | 730030 | China | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.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 https://www.clinicalstudydatarequest.com/.
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There were up to 30 days of screening period (day -30 to -1) before first treatment (day 1).
Participants were enrolled at 19 sites in China
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| ID | Title | Description |
|---|---|---|
| FG000 | Ofatumumab | Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2021 | Oct 23, 2025 |
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Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per participant) as the response variable. The model includes baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans is used as the offset. MRI scans were performed at screening, month 3 and 12 (end of study) and end of follow up for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement. |
| Baseline up to approximately 12 months |
| Annualized Rate of New or Enlarging T2 Lesions | Obtained from fitting a negative binomial regression model with log link function, the total number of new or enlarged T2 lesions (relative to baseline/month 3 scan) during the Month 3/treatment period (per participant) as the response variable. Natural log of time from screening scan in years is used as the offset. The model will include baseline age and baseline volume of T2 lesions as continuous covariates. | Baseline up to approximately 12 months |
| Change in T2 Lesion Volume Relative to Baseline | T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value | Baseline up to approximately 12 months |
| Percentage Change in T2 Lesion Volume Relative to Baseline | T2 lesion volume as measured by MRI and percent change calculated as post baseline value - baseline value divided by baseline value multiplied by 100. | Baseline up to approximately 12 months |
| Baseline up to approximately 12 months |
| Time Based Annualized Relapse Rate (ARR) | A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (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). Time-based ARR was calculated by taking the total number of relapses observed for all subjects within an age group divided by the total number of days in study of all subjects within the group and multiplied by 365.25 days. | Baseline up to approximately 12 months |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510080 | China |
| Novartis Investigative Site | Guangzhou | Guangdong | 510630 | China |
| Novartis Investigative Site | Shijiazhuang | Hebei | 050000 | China |
| Novartis Investigative Site | Harbin | Heilongjiang | 150001 | China |
| Novartis Investigative Site | Wuhan | Hubei | 430030 | China |
| Novartis Investigative Site | Suzhou | Jiangsu | 215004 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110011 | China |
| Novartis Investigative Site | Taiyuan | Shanxi | 030001 | China |
| Novartis Investigative Site | Ürümqi | Xinjiang | 830054 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310006 | China |
| Novartis Investigative Site | Beijing | 065001 | China |
| Novartis Investigative Site | Beijing | 100034 | China |
| Novartis Investigative Site | Guangzhou | 510260 | China |
| Novartis Investigative Site | Shanghai | 200025 | China |
| Novartis Investigative Site | Shenzhen | 518036 | China |
| Novartis Investigative Site | Tianjin | 300052 | China |
| COMPLETED |
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| NOT COMPLETED |
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| Post-treatment follow up period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ofatumumab | Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Number of relapses in the last 12 months prior to screening | Mean | Standard Deviation | relapses/year |
| ||||||||||||||||||||||
| Number of relapses in 12 to 24 months prior to screening | Mean | Standard Deviation | relapses/year |
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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 | Adjusted Annualized Relapse Rate (ARR) Based on Confirmed Relapses | A confirmed MS relapse is defined as one accompanied by a clinically-relevant change in the EDSS performed by the Independent EDSS rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores or 2 points on one functional score (excluding changes involving bowel/bladder or cerebral functional system). Adjusted ARR was obtained from fitting a negative binomial regression model adjusted for number of relapses in the previous year, baseline number of T1 Gd-enhancing lesions and baseline age as continuous covariates (offset: Natural log of time in study in years). | Full analysis set (FAS): comprised of all participants who had signed the Informed Consent and who have had received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | relapses per participant-year | Baseline up to approximately 12 months |
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| Other Pre-specified | Participant Based Annualized Relapse Rate (ARR) | A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (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). Participant-based ARR was calculated by taking the total number of relapses observed for a participant divided by the total number of days in study of that participant and multiplied by 365.25. | Full analysis set (FAS): comprised of all participants who had signed the Informed Consent and who have had received at least one dose of study treatment. | Posted | Mean | Standard Deviation | relapses per participant-year | Baseline up to approximately 12 months |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Time Based Annualized Relapse Rate (ARR) | A relapse is an appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event which is present for at least 24 hours in the absence of fever or infection. A relapse is confirmed by the treating physician when it is accompanied by an increase of at least 0.5 on the Expanded Disability Status Scale (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). Time-based ARR was calculated by taking the total number of relapses observed for all subjects within an age group divided by the total number of days in study of all subjects within the group and multiplied by 365.25 days. | Full analysis set (FAS): comprised of all participants who had signed the Informed Consent and who have had received at least one dose of study treatment. | Posted | Number | relapses per participant-year | Baseline up to approximately 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Adverse Events and Serious Adverse Events | Adverse events and SAEs, including clinically significant laboratory data and vital signs which meet the definition of adverse events | Safety set (SAF): was identical to FAS in this study. FAS: comprised of all participants who had signed the Informed Consent and who have had received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline to safety cut-off up to approximately 15.2 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan | Obtained from fitting a negative binomial regression model with log-link function, the total number of Gd-enhancing T1 lesions during the treatment period (per participant) as the response variable. The model includes baseline age and number of Gd-enhancing T1 lesions at baseline as continuous covariates. Natural log of the number of MRI scans is used as the offset. MRI scans were performed at screening, month 3 and 12 (end of study) and end of follow up for participants that discontinued treatment. Unscheduled MRIs could be performed at the investigator's judgement. | Participants in the Full analysis set (FAS) with available results for this outcome measure. FAS comprised all participants who had signed the Informed Consent and who have had received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | lesions per scan | Baseline up to approximately 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Annualized Rate of New or Enlarging T2 Lesions | Obtained from fitting a negative binomial regression model with log link function, the total number of new or enlarged T2 lesions (relative to baseline/month 3 scan) during the Month 3/treatment period (per participant) as the response variable. Natural log of time from screening scan in years is used as the offset. The model will include baseline age and baseline volume of T2 lesions as continuous covariates. | Participants in the Full analysis set (FAS) with available results for this outcome measure. FAS comprised all participants who had signed the Informed Consent and who have had received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Lesions per participant-year | Baseline up to approximately 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Change in T2 Lesion Volume Relative to Baseline | T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value | Participants in the Full analysis set (FAS) with available results for this outcome measure. FAS comprised all participants who had signed the Informed Consent and who have had received at least one dose of study treatment. | Posted | Mean | Standard Deviation | milliliters | Baseline up to approximately 12 months |
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| Secondary | Percentage Change in T2 Lesion Volume Relative to Baseline | T2 lesion volume as measured by MRI and percent change calculated as post baseline value - baseline value divided by baseline value multiplied by 100. | Participants in the Full analysis set (FAS) with available results for this outcome measure. FAS comprised all participants who had signed the Informed Consent and who have had received at least one dose of study treatment. | Posted | Mean | Standard Deviation | Percent change from baseline | Baseline up to approximately 12 months |
|
|
Baseline to end of post treatment follow-up to approximately 18 months
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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 | Ofatumumab | Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4 | 0 | 99 | 0 | 99 | 69 | 99 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Asthenia | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
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| Chest discomfort | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
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| Influenza like illness | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
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| Injection site reaction | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
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| Pain | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
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| Pyrexia | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (27.1) | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (27.1) | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Groin abscess | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Helicobacter infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Injection related reaction | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Lymphocyte percentage decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Neutrophil percentage increased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (27.1) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
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| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Cervicobrachial syndrome | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
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| Dyssomnia | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (27.1) | Systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
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| Breast mass | Reproductive system and breast disorders | MedDRA (27.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2025 | Oct 23, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C527517 | ofatumumab |
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| 31 to 40 years |
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| 41 to 55 years |
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| > 55 years |
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