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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights

ARTIOS 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.Check my eligibility
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.See study design
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.

ARTIOS Trial Eligibility Criteria

Inclusion Criteria

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

ARTIOS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annual Relapse Rate (ARR)
Secondary outcome measures
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%
Colitis
13%
Asthenia
13%
Weight decreased
13%
Bronchitis
11%
Abdominal pain
11%
Rash
10%
Hypokalaemia
10%
Oedema peripheral
9%
Dyspnoea
9%
Aspartate aminotransferase increased
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%
Toxic skin eruption
3%
Renal failure acute
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%
Enterocolitis
1%
Pneumonia staphylococcal
1%
Urinary tract infection
1%
Pneumonia aspiration
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Interstitial lung disease
1%
Respiratory failure
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia klebsiella
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Proctitis
1%
Fungal oesophagitis
1%
Accidental overdose
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

ARTIOS 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
~1470

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,141 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
51,563 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a high rate of adverse effects associated with Ofatumumab?

"There is both preclinical and clinical evidence for ofatumumab's efficacy, thus it received a score of 3 on our safety scale."

Answered by AI

In how many places is this trial being conducted?

"Right now, this research project is underway at 5 different hospitals. If you want to limit your travel, try and select a location near Sunrise, Indianapolis or Burnaby. The other participating cities are _____, _____ and _____."

Answered by AI

What are the requirements for joining this clinical trial?

"This trial is for people with multiple sclerosis who are between 18-60 years old. The goal is to enrol 555 patients in the study."

Answered by AI

What are the common applications for Ofatumumab?

"Ofatumumab is a treatment option for patients with multiple sclerosis who have not responded well to fludarabine or alemtuzumab, and are ineligible for fludarabine-based therapy."

Answered by AI

Will this research be testing the effects on elderly patients?

"This particular trial is geared for adults aged 18 to 60. However, there are other trials available for both minors and senior citizens."

Answered by AI

How many people are currently involved in this research project?

"That is correct. The website clinicaltrials.gov has information showing that this study is looking for patients right now. 555 people are needed from 5 different locations, and the trial was originally posted on July 14th 2020 with the latest update being October 21st 2022."

Answered by AI

What does the current research landscape look like for Ofatumumab?

"Currently, there are 23 different clinical trials underway that are studying Ofatumumab. 6 of those trials have reached Phase 3 status. The majority of the research facilities for Ofatumumab are located in Houston, Texas; however, across 749 locations worldwide, medical professionals are running these active studies."

Answered by AI

Have other similar tests been conducted in the past?

"Since its inception in 2010, Ofatumumab has been the subject of 23 different clinical studies. The first study was completed by GlaxoSmithKline and it involved 32 patients. Following the successful Phase 1 trial, the medication received Phase 2 drug approval. Now, these 290 cities and 45 countries are all conducting live trials for Ofatumumab."

Answered by AI

Are researchers actively recruiting participants for this clinical trial?

"The clinical trial is still looking for volunteers and was first posted on 7/14/2020. The latest update to the listing was on 10/21/2022"

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04353492.
All > Amyotrophic Lateral Sclerosis
~111 spots leftby Apr 2025
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