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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
Ongoing gMG treatment at a stable dose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
Study Summary
This trial will test if satralizumab is safe and effective in treating generalized myasthenia gravis.
Who is the study for?
This trial is for individuals with generalized myasthenia gravis (gMG), a condition causing muscle weakness. Participants must have a confirmed diagnosis, be able to follow the study protocol, and if of childbearing potential, agree to use contraception or abstain from sex during the study and for 3 months after. Exclusions include recent thymectomy, certain vaccinations, pregnancy/breastfeeding intentions within study duration plus 3 months post-study, ocular MG or recent myasthenic crisis.Check my eligibility
What is being tested?
The trial is testing Satralizumab's effectiveness compared to a placebo in treating gMG. It will assess how well it works (efficacy), its safety profile, how the body processes it (pharmacokinetics), and what it does in the body (pharmacodynamics).See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with medications like Satralizumab may include injection site reactions, increased risk of infections due to immune system suppression, potential liver issues indicated by hepatitis exclusion criteria.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with generalized Myasthenia Gravis.
Select...
I am currently on a stable dose of medication for myasthenia gravis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in AChR-antibody seropositive population
Secondary outcome measures
Mean change from baseline in Myasthenia Gravis Quality of Life 15 Scale (MG-QOL 15r) score
Mean change from baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale score
Mean change from baseline in Quantitative Myasthenia Gravis (QMG) score
+5 moreSide effects data
From 2021 Phase 3 trial • 85 Patients • NCT0202888421%
Upper respiratory tract infection
18%
Nasopharyngitis
15%
Headache
13%
Anaemia
13%
Urinary tract infection
13%
Alanine aminotransferase increased
11%
Alopecia
11%
Hyperlipidaemia
11%
Vertigo
11%
Chest discomfort
11%
Complement factor decreased
11%
Conjunctivitis
10%
Leukopenia
10%
Lymphopenia
8%
Conjunctival haemorrhage
8%
Diarrhoea
8%
Arthralgia
8%
Oral herpes
8%
Cough
8%
Eczema
6%
Oral candidiasis
6%
Bradycardia
6%
Hypertransaminasaemia
6%
Retinal haemorrhage
6%
Hypofibrinogenaemia
6%
Left ventricle outflow tract obstruction
6%
Blepharospasm
6%
Conjunctival deposit
6%
Dry eye
6%
Glaucoma
6%
Excoriation
6%
Blood urine
6%
Protein urine present
6%
Dehydration
6%
Amenorrhoea
6%
Pharyngeal erythema
6%
Acne
6%
Intervertebral disc protrusion
6%
Muscle spasticity
6%
Blood alkaline phosphatase increased
6%
Polycythaemia
6%
Oedema peripheral
6%
Bacteriuria
6%
Pyelonephritis
6%
Respiratory tract infection
6%
Wound
6%
Epistaxis
6%
Musculoskeletal stiffness
6%
Large intestine polyp
6%
Pancreatitis acute
6%
Feeling abnormal
6%
Hepatic function abnormal
6%
Arthropod sting
6%
Feeling hot
6%
Pelvic fracture
6%
Osteoarthritis
6%
Nephrolithiasis
6%
Platelet count decreased
6%
Cataract
6%
Chills
6%
Contusion
6%
Serum ferritin decreased
6%
Dyspepsia
6%
Onychomycosis
6%
Viral upper respiratory tract infection
6%
Upper respiratory tract inflammation
6%
Plicated tongue
6%
Compression fracture
6%
Urobilinogen urine increased
6%
Neck pain
6%
Malaise
6%
Angina pectoris
6%
Abdominal distension
6%
Cellulitis
6%
Enterocolitis infectious
6%
Pneumonia
6%
Joint injury
6%
Weight increased
6%
Myopathy toxic
6%
Spinal osteoarthritis
6%
Epilepsy
6%
Lower limb fracture
6%
Low density lipoprotein increased
6%
Weight decreased
6%
Iron deficiency
6%
Erythema
6%
Rash pruritic
6%
Spinal pain
6%
Intercostal neuralgia
6%
Eye pruritus
6%
Panic disorder
5%
Pain in extremity
5%
Ear discomfort
5%
Neutropenia
5%
Bronchitis
5%
Rib fracture
5%
Constipation
5%
Gastritis
5%
Fall
5%
Cystitis
5%
Blepharitis
5%
Hypocomplementaemia
5%
Laryngitis
5%
Oropharyngeal pain
5%
Dental caries
5%
Sinusitis
5%
Thermal burn
5%
Dyslipidaemia
5%
Hypercholesterolaemia
5%
Myalgia
5%
Anxiety
5%
Flushing
5%
Hypertension
5%
Blood fibrinogen decreased
5%
Blood fibrinogen increased
5%
Blood pressure increased
5%
Prothrombin time prolonged
5%
Rhinorrhoea
5%
Rash
5%
Muscle spasms
3%
Lymphocyte percentage increased
3%
Cervical dysplasia
3%
Gait disturbance
3%
Vomiting
3%
Influenza
3%
Upper limb fracture
3%
Tonsillitis
3%
Haemoglobin decreased
3%
Toothache
3%
Pharyngitis
3%
Dizziness
3%
Hordeolum
3%
Haemorrhoids
3%
Insomnia
3%
Periodontitis
3%
Neutrophil count decreased
3%
White blood cell count decreased
3%
Back pain
3%
Parkinsonism
3%
White blood cell count increased
3%
Hepatitis E
3%
Spinal compression fracture
3%
Large intestine infection
3%
Forearm fracture
3%
Lumbar spinal stenosis
3%
Neuromyelitis optica pseudo relapse
3%
Iron deficiency anaemia
3%
Abdominal pain upper
3%
Rhinitis
3%
Aspartate aminotransferase increased
3%
Urticaria
3%
Blood creatine phosphokinase increased
3%
Lymphocyte count decreased
3%
Non-cardiac chest pain
3%
Neutrophil count increased
3%
Neutrophil percentage increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Baseline Treatment Double Blind Period
Satralizumab + Baseline Treatment Open Label Period
Satralizumab + Baseline Treatment Double Blind Period
Placebo + Baseline Treatment Open Label Period
Satralizumab Open-Label Period
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SatralizumabExperimental Treatment1 Intervention
Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter. Adolescent patients who first enter the study in the OLE period will receive satralizumab SC loading doses at Week 0, 2, and 4 in the OLE, followed by maintenance doses Q4W thereafter and will remain on stable background therapy until Week 24 of the OLE.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Satralizumab
2014
Completed Phase 3
~180
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,433 Previous Clinical Trials
1,090,012 Total Patients Enrolled
2 Trials studying Myasthenia Gravis
272 Patients Enrolled for Myasthenia Gravis
Chugai PharmaceuticalIndustry Sponsor
95 Previous Clinical Trials
21,519 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
888,729 Total Patients Enrolled
2 Trials studying Myasthenia Gravis
272 Patients Enrolled for Myasthenia Gravis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with generalized Myasthenia Gravis.You have a score of 5 or more on the MG-ADL test, with most points coming from non-eye-related symptoms.You have tested positive for hepatitis B virus (HBV) or hepatitis C virus (HCV).I am currently on a stable dose of medication for myasthenia gravis.Your myasthenia gravis is classified as moderate to severe.I have had severe eye-related symptoms or a myasthenic crisis in the last 3 months.I had my thymus gland removed within the last year.I have not received a live vaccine in the last 6 weeks.My parents or guardian and I have both agreed to my participation in the study.I do not have any health conditions that could affect the study.You have signs of tuberculosis, unless you are already taking medicine to prevent it.
Research Study Groups:
This trial has the following groups:- Group 1: Satralizumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any known serious side effects to taking Satralizumab?
"There is some evidence that suggests satralizumab is effective and multiple rounds of data that support its safety, thus it received a 3 on our safety scale."
Answered by AI
What have been the previous findings of other research groups when studying Satralizumab?
"There are currently 2 active clinical trials researching satralizumab. Of those, 2 are in Phase 3. Mendoza and Guipuzcoa have the most active trials for this medication, but there are a total of 181 clinical trial sites."
Answered by AI
Is this trial taking place at a lot of hospitals in North America?
"Currently, the study is live at 18 clinical sites. Some of these locations include Pasadena, Jacksonville and Chicago. To minimize the burden of travelling, it is encouraged that patients select the trial site closest to their location."
Answered by AI
Have patients undergone this experimental treatment before?
"There are 2 ongoing studies concerning the effects of satralizumab in 56 different cities and 26 countries. The first study, which was completed in 2021, was sponsored by Hoffmann-La Roche. It involved 127 patients and finished its Phase 3 drug approval stage. Since 2021, there have been 18240 similar studies conducted."
Answered by AI
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