Ofatumumab for Multiple Sclerosis (MS)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Multiple Sclerosis (MS)Ofatumumab - Drug
Eligibility
18 - 60
All Sexes
What conditions do you have?
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Study Summary

This trial is testing if a medication called ofatumumab is effective, safe, and tolerated in patients with relapsing multiple sclerosis who are transitioning from a different medication.

Eligible Conditions
  • Multiple Sclerosis (MS)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Baseline up to 6 and 12 months

Month 21
Therapeutic procedure
Month 12
Number of participants with no change or reduction in gadolinium enhancing lesions at 12 months
Month 12
Change from baseline for CD3+CD20+ T cell counts
Change from baseline for Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Change from baseline for total CD19+ B cell counts and CD3+CD20+ T cell counts
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ofatumumab
21%Neutropenia
18%Infusion related reaction
14%Cough
12%Fatigue
12%Diarrhoea
12%Rash
11%Asthenia
11%Nausea
10%Anaemia
10%Paraesthesia
10%Pyrexia
8%Constipation
8%Headache
8%Upper respiratory tract infection
8%Bronchitis
6%Insomnia
6%Paraesthesia oral
6%Pruritus
6%Thrombocytopenia
6%Vomiting
6%Dyspnoea
5%Oedema peripheral
5%Back pain
5%Hypotension
5%Muscle spasms
3%Arthralgia
3%Pneumonia
3%Decreased appetite
3%Hyperkalaemia
3%Dyspepsia
3%Abdominal pain upper
3%Hypertension
3%Nasopharyngitis
3%Dizziness
2%Febrile neutropenia
2%Alanine aminotransferase increased
2%Respiratory tract infection
2%Rhinorrhoea
2%Escherichia sepsis
2%Aspartate aminotransferase increased
2%Weight decreased
2%Abdominal pain
2%Hypokalaemia
2%Pain in extremity
1%Hyperglycaemia
1%Neutropenic sepsis
1%Sepsis
1%Productive cough
1%Colitis
1%Dry mouth
1%Infusion site extravasation
1%Rash maculo-papular
1%Hypercalcaemia
1%Peripheral embolism
1%Pneumonia viral
1%Device related infection
1%Haemolytic anaemia
1%Atrial fibrillation
1%Cholecystitis
1%Drug hypersensitivity
1%Hepatic failure
1%Lymph node pain
1%Oesophageal ulcer
1%Dehydration
1%Malignant melanoma
1%Hypervolaemia
1%Portal hypertensive gastropathy
1%Deep vein thrombosis
1%Contrast media allergy
1%Streptococcal bacteraemia
1%Squamous cell carcinoma of lung
1%Clostridium difficile infection
1%Hyponatraemia
1%Disease progression
1%Herpes virus infection
1%Glioblastoma multiforme
1%Squamous cell carcinoma
1%Ischaemic stroke
1%Renal failure acute
1%Pulmonary embolism
1%Laryngeal stenosis
1%Malignant pleural effusion
1%Pneumonia bacterial
1%Fall
1%Angina pectoris
1%Escherichia urinary tract infection
1%Gastroenteritis
1%Cardiac failure
1%Tachycardia
1%Enterocolitis
1%Lower respiratory tract infection
1%Chronic sinusitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT02004522) in the Ofatumumab ARM group. Side effects include: Neutropenia with 21%, Infusion related reaction with 18%, Cough with 14%, Fatigue with 12%, Diarrhoea with 12%.

Trial Design

1 Treatment Group

Ofatumumab
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Ofatumumab · No Placebo Group · Phase 3

Ofatumumab
Drug
Experimental Group · 1 Intervention: Ofatumumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 6 and 12 months

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,804 Total Patients Enrolled

Eligibility Criteria

Age 18 - 60 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received at least one fully infused dose of rituximab within 4-9 months prior to baseline.
The regimen of rituximab is as follows: 500 mg on day 1 and on day 15, followed by 1000 mg on day 1 and on day 15.
You must be able to use a smart device or have a caregiver that can assist.
You have relapsing-remitting MS (RRMS) according to the 2017 Revised McDonald criteria (Thompson et al