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Monoclonal Antibodies

Relapsing-remitting Multiple Sclerosis for Multiple Sclerosis

N/A
Waitlist Available
Led By Eve Kelland, Ph.D.
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 months
Awards & highlights
No Placebo-Only Group

Summary

In this study the investigators wish to test the hypothesis that the repertoire of solutes secreted by leukocytes isolated from patients with relapsing-remitting forms of Multiple Sclerosis (MS) following 6 months of treatment with Ofatumumab (Kesimpta®) will be less toxic to mouse-derived oligodendrocyte lineage cells, grown in a dish, than solutes secreted by the same leukocyte populations prior to treatment with Ofatumumab.

Eligible Conditions
  • Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of oligodendrocyte death and mitochondrial dysfunction comparing supernatant samples from patients after 6 months treatment (M06) to pre-treatment, drug naïve supernatants (M00) and to supernatants collected from healthy control subjects
Secondary study objectives
Identify factor(s) associated with oligodendrocyte and OPC stress/death

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%
Pneumonia staphylococcal
1%
Respiratory failure
1%
Pleural haemorrhage
1%
Streptococcal sepsis
1%
Interstitial lung disease
1%
Skin infection
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.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Relapsing-remitting Multiple SclerosisExperimental Treatment1 Intervention
Enrolled subjects in this group will have clinically definite Multiple Sclerosis as defined by the revised McDonald criteria of the relapsing-remitting form with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5 and will be treated with Ofatumumab.
Group II: Healthy Control SubjectsExperimental Treatment0 Interventions
Enrolled subjects must not have clinically definite Multiple Sclerosis as defined by the revised McDonald criteria, any other autoimmune disease, demyelinating co-morbidity, neurological disease or immune system altering disease.
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?

University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,605 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
652 Patients Enrolled for Multiple Sclerosis
Novartis PharmaceuticalsIndustry Sponsor
2,911 Previous Clinical Trials
4,250,636 Total Patients Enrolled
107 Trials studying Multiple Sclerosis
51,748 Patients Enrolled for Multiple Sclerosis
Eve Kelland, Ph.D.Principal InvestigatorUniversity of Southern California
~0 spots leftby Dec 2024
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