Ofatumumab for Relapsing Remitting Multiple Sclerosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Relapsing Remitting Multiple SclerosisOfatumumab - Drug
Eligibility
18 - 35
All Sexes
What conditions do you have?
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Study Summary

This trial will study the effects of ofatumumab in people with RRMS who are in the early stages of the disease. The study will use clinical and MRI outcomes to track changes in the disease, as well as digital devices, biomarkers, and non-conventional MRI. The results of the ofatumumab group will be compared to a group of healthy people to see if there are any similarities between the two groups after treatment.

Eligible Conditions
  • Relapsing Remitting Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Month 6 to Month 18 and 30

Month 18
Change from Baseline for NeuroQOL
Change from Baseline for Patient Determined Disease Steps (PDDS)
Change from Baseline in Gd+ lesion count
Change from Baseline in Gd+ lesion volume
Change from Baseline in T2 lesion volume
Change from Baseline in new/enlarging T2 lesion count
Number of relapses
Month 18
Number of participants that were 3-month Disability Worsening-free
Month 30
Number of participants with treatment emergent adverse events
Month 18
Number of participants with NEDA (No Evidence of Disease Activity) - Clinical
Number of participants with NEDA (No Evidence of Disease Activity) - Radiological
Month 18
Brain volume loss (BVL) assessment (whole brain and regional)
Month 18
Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)

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%Alanine aminotransferase increased
2%Febrile neutropenia
2%Rhinorrhoea
2%Respiratory tract infection
2%Escherichia sepsis
2%Aspartate aminotransferase increased
2%Weight decreased
2%Abdominal pain
2%Hypokalaemia
2%Pain in extremity
1%Neutropenic sepsis
1%Hyperglycaemia
1%Productive cough
1%Sepsis
1%Colitis
1%Dry mouth
1%Infusion site extravasation
1%Rash maculo-papular
1%Peripheral embolism
1%Hypercalcaemia
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

2 Treatment Groups

Healthy Control
1 of 2
Ofatumumab
1 of 2

Active Control

Experimental Treatment

168 Total Participants · 2 Treatment Groups

Primary Treatment: Ofatumumab · No Placebo Group · Phase 4

Ofatumumab
Drug
Experimental Group · 1 Intervention: Ofatumumab · Intervention Types: Drug
Healthy ControlNoIntervention Group · 1 Intervention: Healthy Control · Intervention Types:
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: month 6 to month 18 and 30

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,687 Total Patients Enrolled

Eligibility Criteria

Age 18 - 35 · All Participants · 10 Total Inclusion Criteria

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