Trial Outcomes & Findings for Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China (NCT NCT05199571)
NCT ID: NCT05199571
Last Updated: 2025-11-12
Results Overview
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).
COMPLETED
PHASE4
99 participants
Baseline up to approximately 12 months
2025-11-12
Participant Flow
Participants were enrolled at 19 sites in China
There were up to 30 days of screening period (day -30 to -1) before first treatment (day 1).
Participant milestones
| Measure |
Ofatumumab
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Treatment Period
STARTED
|
99
|
|
Treatment Period
COMPLETED
|
95
|
|
Treatment Period
NOT COMPLETED
|
4
|
|
Post-treatment Follow up Period
STARTED
|
29
|
|
Post-treatment Follow up Period
COMPLETED
|
26
|
|
Post-treatment Follow up Period
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Ofatumumab
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Treatment Period
Participant decision
|
3
|
|
Treatment Period
Physician Decision
|
1
|
|
Post-treatment Follow up Period
Participant decision
|
3
|
Baseline Characteristics
Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China
Baseline characteristics by cohort
| Measure |
Ofatumumab
n=99 Participants
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 8.98 • n=10 Participants
|
|
Age, Customized
< 18 years
|
0 Participants
n=10 Participants
|
|
Age, Customized
18 to 30 years
|
46 Participants
n=10 Participants
|
|
Age, Customized
31 to 40 years
|
38 Participants
n=10 Participants
|
|
Age, Customized
41 to 55 years
|
15 Participants
n=10 Participants
|
|
Age, Customized
> 55 years
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
99 Participants
n=10 Participants
|
|
Number of relapses in the last 12 months prior to screening
|
1.1 relapses/year
STANDARD_DEVIATION 0.59 • n=10 Participants
|
|
Number of relapses in 12 to 24 months prior to screening
|
0.6 relapses/year
STANDARD_DEVIATION 0.80 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Ofatumumab
n=99 Participants
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Adjusted Annualized Relapse Rate (ARR) Based on Confirmed Relapses
|
0.05 relapses per participant-year
Interval 0.02 to 0.13
|
SECONDARY outcome
Timeframe: Baseline to safety cut-off up to approximately 15.2 monthsPopulation: 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.
Adverse events and SAEs, including clinically significant laboratory data and vital signs which meet the definition of adverse events
Outcome measures
| Measure |
Ofatumumab
n=99 Participants
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Number of Adverse Events and Serious Adverse Events
Adverse events (AEs)
|
69 Participants
|
|
Number of Adverse Events and Serious Adverse Events
Serious adverse events (SAEs)
|
0 Participants
|
|
Number of Adverse Events and Serious Adverse Events
AEs related to treatment
|
52 Participants
|
|
Number of Adverse Events and Serious Adverse Events
AEs leading to treatment discontinuation
|
0 Participants
|
|
Number of Adverse Events and Serious Adverse Events
AEs leading to treatment interruption
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Ofatumumab
n=98 Participants
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Number of Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan
|
0.04 lesions per scan
Interval 0.02 to 0.1
|
SECONDARY outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Ofatumumab
n=95 Participants
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Annualized Rate of New or Enlarging T2 Lesions
Relative to baseline
|
1.95 Lesions per participant-year
Interval 1.38 to 2.75
|
|
Annualized Rate of New or Enlarging T2 Lesions
Relative to Month 3
|
0.21 Lesions per participant-year
Interval 0.09 to 0.49
|
SECONDARY outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: 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.
T2 lesion volume as measured by MRI and calculated as post-baseline value - baseline value
Outcome measures
| Measure |
Ofatumumab
n=97 Participants
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Change in T2 Lesion Volume Relative to Baseline
Month 3
|
-0.03 milliliters
Standard Deviation 1.172
|
|
Change in T2 Lesion Volume Relative to Baseline
Month 12
|
-0.32 milliliters
Standard Deviation 1.116
|
SECONDARY outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: 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.
T2 lesion volume as measured by MRI and percent change calculated as post baseline value - baseline value divided by baseline value multiplied by 100.
Outcome measures
| Measure |
Ofatumumab
n=97 Participants
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Percentage Change in T2 Lesion Volume Relative to Baseline
Month 3
|
1.50 Percent change from baseline
Standard Deviation 8.681
|
|
Percentage Change in T2 Lesion Volume Relative to Baseline
Month 12
|
-1.88 Percent change from baseline
Standard Deviation 7.083
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Ofatumumab
n=99 Participants
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Participant Based Annualized Relapse Rate (ARR)
Confirmed relapses
|
0.058 relapses per participant-year
Standard Deviation 0.2528
|
|
Participant Based Annualized Relapse Rate (ARR)
All relapses
|
0.090 relapses per participant-year
Standard Deviation 0.3066
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to approximately 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Ofatumumab
n=99 Participants
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
Time Based Annualized Relapse Rate (ARR)
Confirmed relapses
|
0.056 relapses per participant-year
|
|
Time Based Annualized Relapse Rate (ARR)
All relapses
|
0.089 relapses per participant-year
|
Adverse Events
Ofatumumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ofatumumab
n=99 participants at risk
Ofatumumab 20 mg subcutaneous injections at Week 0, 1, 2 and monthly thereafter starting at Week 4
|
|---|---|
|
General disorders
Injection site reaction
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
General disorders
Pain
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
General disorders
Pyrexia
|
7.1%
7/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.0%
4/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Immune system disorders
Anaphylactic reaction
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Immune system disorders
Hypersensitivity
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Bacterial infection
|
3.0%
3/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
COVID-19
|
12.1%
12/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Conjunctivitis
|
2.0%
2/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Folliculitis
|
2.0%
2/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Groin abscess
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Helicobacter infection
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Hordeolum
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Influenza
|
2.0%
2/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
2/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Rhinitis
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Sinusitis
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
12/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Infections and infestations
Urinary tract infection
|
7.1%
7/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
43.4%
43/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Investigations
Blood pressure increased
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Investigations
Liver function test abnormal
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Investigations
Lymphocyte count decreased
|
3.0%
3/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Investigations
Lymphocyte percentage decreased
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Investigations
Neutrophil count decreased
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Investigations
Neutrophil percentage increased
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Investigations
White blood cell count decreased
|
2.0%
2/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Nervous system disorders
Dizziness
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Psychiatric disorders
Bipolar disorder
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Psychiatric disorders
Depression
|
2.0%
2/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Psychiatric disorders
Dyssomnia
|
3.0%
3/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Renal and urinary disorders
Renal cyst
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Renal and urinary disorders
Renal impairment
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Reproductive system and breast disorders
Breast mass
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.0%
2/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
2/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Gastrointestinal disorders
Constipation
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
General disorders
Asthenia
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
General disorders
Chest discomfort
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
|
General disorders
Influenza like illness
|
1.0%
1/99 • Baseline to end of post treatment follow-up to approximately 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER