Ofatumumab for Relapsing Remitting Multiple Sclerosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Relapsing Remitting Multiple SclerosisOfatumumab - Drug
Eligibility
18 - 50
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether relapsing-remitting MS patients who have not had a relapse in the past year would benefit from switching to ofatumumab, and whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from ofatumumab.

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 · 16 Secondary · Reporting Duration: Months 3 to 15

Month 15
Mean change from Baseline in T1
Mean whole brain and regional volume loss from Baseline
Percentage of participants reporting treatment emergent adverse events (TEAEs) and serious adverse events
Month 3
Mean change in Gd+ lesion count
Mean change in Gd+ lesion volume
Mean change in T2 lesion count
Mean change in T2 lesion volume
Mean change in The Symbol-Digit Modality Test
Mean change in the 9 Hole Peg Test
Mean change in the Time 25 Foot Walk
Month 15
Mean change in MSQOL-54
Months 3 to 15
Annualized relapse rate in Months 3 to 15
Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)
Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical
Percentage of participants with NEDA (No Evidence of Disease Activity) - Radiological
Percentage of participants without a worsening of their disability
Months 3 to15
Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml 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%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%Colitis
1%Dry mouth
1%Infusion site extravasation
1%Rash maculo-papular
1%Peripheral embolism
1%Hypercalcaemia
1%Productive cough
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

DMT continued therapy
1 of 2
Ofatumumab
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Ofatumumab · No Placebo Group · Phase 4

Ofatumumab
Drug
Experimental Group · 1 Intervention: Ofatumumab · Intervention Types: Drug
DMT continued therapy
Drug
ActiveComparator Group · 1 Intervention: Disease modifying treatment (DMT) · 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: months 3 to 15

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,705 Total Patients Enrolled

Eligibility Criteria

Age 18 - 50 · All Participants · 10 Total Inclusion Criteria

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