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Monoclonal Antibodies

Ofatumumab for Multiple Sclerosis

Phase 4
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up vaccination up to 4 weeks
Awards & highlights

Study Summary

This trialtests if a medication can help people mount an adequate immune response to the flu vaccine.

Eligible Conditions
  • Multiple Sclerosis (MS)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~vaccination up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and vaccination up to 4 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
Percentage of subjects who achieved seroprotection
Secondary outcome measures
Change in HI titers from prevaccinations up to Week 4
Number of participants reporting treatment emergent adverse events (TEAEs) and serious adverse events
Percentage of subjects who achieved seroconversion

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%
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%
Enterocolitis
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Urinary tract infection
1%
Respiratory failure
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia aspiration
1%
Pneumonia klebsiella
1%
Streptococcal sepsis
1%
Interstitial lung disease
1%
Rash erythematous
1%
Proctitis
1%
Pneumonia staphylococcal
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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
RMS patients currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 an inactivated influenza vaccine
Group II: Cohort 2Experimental Treatment2 Interventions
RMS patients receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start.
Group III: Cohort 1Experimental Treatment2 Interventions
RMS patients receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine at least two weeks prior to ofatumumab start
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quadrivalent influenza vaccine
2016
Completed Phase 4
~11420
Ofatumumab
FDA approved

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,346 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
52,119 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

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

What have been the reported adverse effects associated with Ofatumumab treatment?

"Our team has rated the safety of Ofatumumab a 3, owing to its Phase 4 status. This implies that this drug is approved and available for public use."

Answered by AI

Is there any availability for new participants in this research project?

"As per clinicaltrials.gov, this investigation has commenced recruitment of participants; the trial was first advertised on January 14th 2021 and most recently revised on December 5th 2022."

Answered by AI

How many participants are included in the study cohort?

"Affirmative. Clinicaltrials.gov indicates that this research is currently seeking applicants, which were first posted on January 14th 2021 and modified as recently as December 5th 2022. The study requires 66 participants to be recruited from 4 different sites."

Answered by AI

Has anything like this been attempted before?

"As of now, 24 active clinical trials utilizing Ofatumumab are being conducted in 292 cities and 45 countries. The initial investigation of this therapeutic agent began back in 2010 when GlaxoSmithKline sponsored a Phase 2 trial that included 32 participants; since then, 77 additional studies have been concluded."

Answered by AI

In what ways is Ofatumumab utilized to improve patient health?

"Ofatumumab is regularly prescribed to patients suffering from multiple sclerosis, as well as those with refractory fludarabine and alemtuzumab, who are unable to utilize fludarabine-based therapies, or have active secondary progressive multiple sclerosis (spms)."

Answered by AI

Is it possible to register for participation in this clinical trial?

"66 individuals aged between 18 and 55 who have been diagnosed with multiple sclerosis are required for this medical trial. Moreover, they must intend to receive the 2020-2021 inactivated influenza vaccine, remain willing to observe the study's timeline and be compliant throughout."

Answered by AI

How many medical institutions are currently hosting this research trial?

"In order to reduce the burden of travel, prospective participants should select one of 4 trial sites that are closest to them. These locations include Sunrise, Saint Louis and Vienna amongst a few other destinations."

Answered by AI

What prior investigations involving Ofatumumab have taken place?

"Of the 24 studies currently examining Ofatumumab, 6 are in Phase 3. Most of these trials are taking place in Houston, Texas; however, global participation is available from 753 sites across multiple countries."

Answered by AI

Is the trial open to individuals aged fifty and above?

"This clinical trial has specific age parameters for participation, with a floor of 18 years old and a ceiling of 55."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
2021. "A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04667117.
~2 spots leftby Apr 2025
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