Trial Outcomes & Findings for An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab (NCT NCT04353492)
NCT ID: NCT04353492
Last Updated: 2025-11-12
Results Overview
ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient (adjusted for time-in-study by patient). Confirmed relapses are those accompanied by a clinically relevant change in the expanded disability status scale (EDSS). ARR was estimated from fitting a negative binomial regression model with log-link, and adjusted for prior MS therapies as a factor, number of relapses in previous year, baseline EDSS, baseline number of T1 Gd-enhancing lesions and the subject's age at baseline as covariates. The primary analysis describes the ARR with one-sided 95% confidence bound and test for null hypothesis (H0): ARR \>=0.18 versus alternative hypothesis (H1): ARR\<0.18.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
562 participants
Primary outcome timeframe
Up to 96 weeks from baseline
Results posted on
2025-11-12
Participant Flow
Participants were enrolled in 27 countries.
666 subjects were screened and 562 subjects were enrolled. Study had an up to 60 days screening period including baseline.
Participant milestones
| Measure |
Ofatumumab
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
|
|---|---|
|
Overall Study
STARTED
|
562
|
|
Overall Study
COMPLETED
|
523
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
Ofatumumab
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
|
|---|---|
|
Overall Study
Subject decision
|
24
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Pregnancy
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol deviation
|
1
|
|
Overall Study
Technical problems
|
1
|
Baseline Characteristics
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab
Baseline characteristics by cohort
| Measure |
Ofatumumab
n=562 Participants
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
|
|---|---|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 9.65 • n=10 Participants
|
|
Age, Customized
18 to 30 years
|
185 Participants
n=10 Participants
|
|
Age, Customized
31 to 40 years
|
181 Participants
n=10 Participants
|
|
Age, Customized
41 to 55 years
|
190 Participants
n=10 Participants
|
|
Age, Customized
>55 years
|
6 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
369 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
68 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
480 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
550 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Number of relapses in the last 12 months prior to screening
|
0.9 relapses
STANDARD_DEVIATION 0.71 • n=10 Participants
|
|
Number of relapses in the last 12 to 24 months prior to screening
|
0.8 relapses
STANDARD_DEVIATION 1.04 • n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 96 weeks from baselinePopulation: The Full Analysis Set (FAS) comprises all subjects to whom study treatment has been assigned and who received at least one dose of study treatment
ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient (adjusted for time-in-study by patient). Confirmed relapses are those accompanied by a clinically relevant change in the expanded disability status scale (EDSS). ARR was estimated from fitting a negative binomial regression model with log-link, and adjusted for prior MS therapies as a factor, number of relapses in previous year, baseline EDSS, baseline number of T1 Gd-enhancing lesions and the subject's age at baseline as covariates. The primary analysis describes the ARR with one-sided 95% confidence bound and test for null hypothesis (H0): ARR \>=0.18 versus alternative hypothesis (H1): ARR\<0.18.
Outcome measures
| Measure |
Ofatumumab
n=562 Participants
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
|
|---|---|
|
Annualized Relapse Rate (ARR)
|
0.06 relapses/ participant-year
Interval 0.05 to 0.08
|
SECONDARY outcome
Timeframe: From treatment day 1 to 100 days after last treatment up to approximatelly 26.6 monthsPopulation: The Safety Set (SAF) includes all subjects who received at least one dose of study treatment.
Number of of participants with treatment emergent AEs and SAEs including injection related reactions, abnormal laboratory results or vital signs reported and qualifying as AEs.
Outcome measures
| Measure |
Ofatumumab
n=562 Participants
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
|
|---|---|
|
Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs)
|
509 Participants
|
|
Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs)
|
33 Participants
|
|
Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment related AEs
|
374 Participants
|
|
Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE causing study treatment discontinuation
|
5 Participants
|
|
Number of of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE causing study treatment interruption
|
33 Participants
|
Adverse Events
OMB 20mg
Serious events: 34 serious events
Other events: 466 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OMB 20mg
n=562 participants at risk
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Cardiac disorders
Tachycardia
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Ear and labyrinth disorders
Vertigo
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
Abscess limb
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
Chronic sinusitis
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
Clostridium difficile infection
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
Dengue fever
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
Urinary tract infection
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Investigations
Magnetic resonance imaging abnormal
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
2/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medullary carcinoma of breast
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.36%
2/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Nervous system disorders
Headache
|
0.36%
2/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.36%
2/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Nervous system disorders
Optic neuritis
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Nervous system disorders
Sciatica
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Psychiatric disorders
Acute psychosis
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Psychiatric disorders
Depression
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Psychiatric disorders
Suicidal ideation
|
0.36%
2/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Reproductive system and breast disorders
Ovarian haematoma
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Gastrointestinal disorders
Ascites
|
0.18%
1/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
Other adverse events
| Measure |
OMB 20mg
n=562 participants at risk
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
|
|---|---|
|
General disorders and administration site conditions
Fatigue
|
6.0%
34/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
General disorders and administration site conditions
Injection site reaction
|
11.0%
62/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
COVID-19
|
37.0%
208/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
Influenza
|
5.2%
29/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
Nasopharyngitis
|
17.1%
96/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.9%
78/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
59/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
53.4%
300/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
40/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
40/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Nervous system disorders
Headache
|
16.2%
91/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
29/562 • From first dose of study treatment until 6 months after last dose up to 29.4 months approximately.
|
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