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Monoclonal Antibodies

Ofatumumab for Multiple Sclerosis (ARTIOS Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4
Relapsing MS including RMS and secondary progressive MS (SPMS)
Must not have
Subjects meeting criteria for neuromyelitis optica
Subjects with primary progressive MS or SPMS without disease activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test how well ofatumumab works in people with relapsing-remitting multiple sclerosis who are switching from another approved MS drug.

Who is the study for?
This trial is for people with relapsing forms of Multiple Sclerosis (RMS), including secondary progressive MS, who have tried up to three Disease Modifying Therapies. Participants should have an EDSS score from 0 to 4 and must be transitioning from fumarate-based therapies or fingolimod due to disease activity despite treatment.
What is being tested?
The study tests the effectiveness of Ofatumumab in patients switching from fumarate-based RMS therapies or fingolimod because their MS was active even while on these treatments. It's an open-label trial, meaning both researchers and participants know what treatment is being given.
What are the potential side effects?
Ofatumumab can cause side effects like infusion reactions, infections due to a weakened immune system, and possibly other immune-related issues. The exact side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disability level is low to moderate.
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My condition is relapsing multiple sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with neuromyelitis optica.
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My MS is either primary progressive or secondary progressive without recent activity.
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I have symptoms or a diagnosis of PML.
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I do not have any active infections or AIDS.
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I have active hepatitis B or C.
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I have not received any live vaccines in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annual Relapse Rate (ARR)
Secondary study objectives
Safety evaluation

Side effects data

From 2021 Phase 3 trial • 319 Patients • NCT02004522
50%
Diarrhoea
34%
Neutropenia
29%
Pyrexia
25%
Anaemia
24%
Nausea
23%
Cough
17%
Thrombocytopenia
17%
Constipation
16%
Fatigue
16%
Pneumonia
15%
Vomiting
15%
Decreased appetite
14%
Upper respiratory tract infection
13%
Asthenia
13%
Colitis
13%
Weight decreased
13%
Bronchitis
11%
Abdominal pain
11%
Rash
10%
Hypokalaemia
10%
Oedema peripheral
9%
Aspartate aminotransferase increased
9%
Dyspnoea
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Arthralgia
7%
Pruritus
7%
Hyperkalaemia
7%
Respiratory tract infection
6%
Rash maculo-papular
6%
Febrile neutropenia
6%
Rhinorrhoea
6%
Dyspepsia
6%
Pain in extremity
6%
Abdominal pain upper
5%
Dehydration
5%
Insomnia
5%
Productive cough
5%
Dry mouth
4%
Muscle spasms
4%
Paraesthesia
4%
Pneumonitis
3%
Renal failure acute
3%
Toxic skin eruption
3%
Hypotension
3%
General physical health deterioration
3%
Gastroenteritis
2%
Gastritis
2%
Pneumonia pseudomonas aeruginosa
2%
Pancytopenia
2%
Cardiac failure
2%
Sepsis
2%
Pneumocystis jirovecii pneumonia
2%
Pneumonia pneumococcal
2%
Pulmonary embolism
1%
Pneumonia aspiration
1%
Pneumonia klebsiella
1%
Urinary tract infection
1%
Respiratory failure
1%
Pleural haemorrhage
1%
Streptococcal sepsis
1%
Interstitial lung disease
1%
Skin infection
1%
Pneumonia staphylococcal
1%
Rash erythematous
1%
Accidental overdose
1%
Fungal oesophagitis
1%
Upper gastrointestinal haemorrhage
1%
Proctitis
1%
Enterocolitis
1%
Mental impairment
1%
Intestinal adenocarcinoma
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Pericarditis
1%
Death
1%
Mucosal inflammation
1%
Multi-organ failure
1%
Sudden death
1%
Transitional cell carcinoma
1%
Bronchiolitis
1%
Bronchitis viral
1%
Bronchopneumonia
1%
Cytomegalovirus colitis
1%
Pneumonia escherichia
1%
Pneumonia mycoplasmal
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Subdural haematoma
1%
Lipase increased
1%
Nephrolithiasis
1%
Renal colic
1%
Renal failure
1%
Renal failure chronic
1%
Lung disorder
1%
Ventricular tachycardia
1%
Colitis ischaemic
1%
Enteritis
1%
Pancreatitis acute
1%
Ileal ulcer
1%
Aspergillus infection
1%
Bronchopulmonary aspergillosis
1%
Campylobacter gastroenteritis
1%
Clostridium difficile colitis
1%
Fungal infection
1%
Influenza
1%
Pseudomonal sepsis
1%
Lower respiratory tract infection
1%
Pneumonia bacterial
1%
Enterococcal infection
1%
Enterococcal sepsis
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Gastroenteritis viral
1%
Haemophilus infection
1%
Infection
1%
Infusion site cellulitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection viral
1%
Lung infection
1%
Pneumonia respiratory syncytial viral
1%
Pneumonia streptococcal
1%
Pseudomonas bronchitis
1%
Wound infection staphylococcal
1%
Cervical vertebral fracture
1%
Femur fracture
1%
Traumatic haematoma
1%
Malnutrition
1%
Hyponatraemia
1%
Tumour lysis syndrome
1%
Arthritis
1%
Bone pain
1%
Malignant melanoma
1%
Brain stem haemorrhage
1%
Dementia
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Dermatitis exfoliative
1%
Thrombosis
1%
Infusion related reaction
1%
Neuroendocrine tumour
1%
Pleural effusion
1%
Mallory-Weiss syndrome
1%
Diverticulitis
1%
Pyelonephritis
1%
Haemorrhagic stroke
1%
Dermatitis allergic
1%
Respiratory tract infection bacterial
1%
Splenic rupture
1%
Neuroendocrine carcinoma of the skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duvelisib
Ofatumumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OfatumumabExperimental Treatment1 Intervention
Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
2013
Completed Phase 3
~1460

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,113 Total Patients Enrolled
107 Trials studying Multiple Sclerosis
51,224 Patients Enrolled for Multiple Sclerosis

Media Library

Ofatumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04353492 — Phase 3
Multiple Sclerosis Research Study Groups: Ofatumumab
Multiple Sclerosis Clinical Trial 2023: Ofatumumab Highlights & Side Effects. Trial Name: NCT04353492 — Phase 3
Ofatumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04353492 — Phase 3
~40 spots leftby Apr 2025
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