Myasthenia Gravis CrisisPhase 4NCT06860633
Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod
A Phase 4 study testing Efgartigimod in people with Myasthenia Gravis Crisis and Myasthenia Gravis Exacerbations, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine receptor (AChR) antibody… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis Crisis, Myasthenia Gravis Exacerbations, AChR Myasthenia Gravis
- What is being tested?
- Efgartigimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ age 18 years with known generalized MG as identified by characteristic signs of generalized MG on clinical assessment and positive serology for AchR antibodies as well as one of the following:
- Documented positive response to cholinesterase inhibitors such as pyridostigmine or edrophonium
- Abnormal decrement on slow repetitive nerve stimulation testing
- Abnormal single fiber EMG
- Evidence of worsening weakness requiring hospital admission for stabilization and change in therapy as determined by a neuromuscular expert including:
- Quantitative Myasthenia Gravis (QMG) scale ≥ 11
Show all 9Show fewer
- MG-ADL score ≥ 6
- Worsening weakness that is unlikely to be ameliorated by adjustment of current medications including impaired respiratory status, dysarthria, dysphagia, difficulty chewing, limb weakness, diplopia, ptosis.
- Ability to sign consent and be enrolled within 24 hours of hospital admission. For participants transferred to University of Colorado Hospital, the time of admission/presentation to the outside hospital is counted towards this 24-hour cap.
Who cannot join
- MG worsening thought to be related to active infection or due to medications (e.g. fluoroquinolone or aminoglycoside antibiotics, magnesium, chloroquine derivatives)
- Intubation prior to ability to sign informed consent or intubation within 24 hours of hospitalization
- Use of IVIG within 2 weeks, or having undergone plasma exchange or received efgartigimod in the 4 weeks prior to admission
- Current ongoing use of ravulizumab or eculizumab (monoclonal antibody C5-complement inhibitors).
- Other medical conditions that, in the opinion of the investigator and treating clinicians, might interfere with the validity of assessment measures used in the study (e.g. steroid myopathy, CNS pathology, severe arthritis, fractures, etc.). This criterion is a standard exclusion in MG trials and relates solely to other conditions that reduce muscle power or range of motion and would thus worsen scores on assessment measures like the QMG due to non-MG conditions.
- Known history of coagulopathy, blood clotting, recent severe bleeding (e.g. GI bleed).
Show all 9Show fewer
- Pregnancy or breastfeeding. Pregnancy must be excluded for all potential participants who are able to become pregnant prior to initiation of treatment.
- IgG levels < 600mg/dL
- Evidence of active or chronic Hepatitis B infection, untreated Hepatitis C infection, HIV with low CD4 (<200) count.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Alyssa Avilez, BS, 303-724-3522, alyssa.avilez@cuanschutz.edu
Thomas Ragole, MD
About this study
Official title: Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod: A Single Arm, Open Label Prospective Cohort Study
This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive but has not been studied in the treatment of worsening weakness requiring hospital admission (known as "exacerbation"). This investigation aims to see if using efgartigimod in this way improves symptoms and recovery from exacerbation, and how it affects certain MG markers in the blood. The main questions it aims to answer are:
- Is efgartigimod effective as a hospital-administered acute therapy for participants with worsening MG (MG exacerbation) who require hospitalization?
- Will efgartigimod lead to clinical improvement with a similar reduction in validated research scales, such as the Quantitative MG (QMG) scale, as standard of care therapies?
Participants will receive 4 doses of efgartigimod over the course of 4 weeks with an additional follow-up visit at the clinic.
Read the detailed description
Efgartigimod is thought to work by reducing circulating IgG antibodies, including the antibodies that cause MG. One of the currently used treatments for MG exacerbation, called plasma exchange (PLEX), is also thought to work by reducing antibody levels by filtering blood through a machine similar to those used in dialysis for kidney failure. Because of the similarities between how these two treatments work, there is reason to believe that efgartigimod may also be helpful in treating MG exacerbation.
- Being tested
- Efgartigimod
- Keywords
- myasthenia exacerbation, efgartigimod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfgartigimodDrug
Also called Vyvgart
Dose of 10 mg/kg for IV infusion on days 1, 4, 11 and 18
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod | Experimental | Participants receive 4 doses of efgartigimod via intravenous (IV) infusion over the course of the study on days 1, 4, 11 and 18. Receives: Drug: Efgartigimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 11
The Quantitative Myasthenia Gravis (QMG) is a scoring system that quantifies disease severity by measuring ocular, bulbar, respiratory and limb strength. The total scores range from 0 to 39, with higher scores indicating greater disease severity.
Measured: Baseline, Day 11
Secondary outcomes (19)
Percentage of participants requiring rescue therapy with Plasma Exchange (PLEX) or Intravenous Immunoglobulin (IVIG)
Number of participants requiring rescue therapy with Plasma Exchange (PLEX) or Intravenous Immunoglobulin (IVIG) over number of total participants
Measured: During hospitalization, approximately 7 days
Change from baseline in Myasthenia Gravis Activities of Daily Life (MG-ADL) scale at day 18
The Myasthenia Gravis Activities of Daily Life (MG-ADL) is a questionnaire administered verbally that measures MG symptoms and functional activities related to activities of daily living. The summative total scores range from 0 to 24, with higher scores indicating greater disease severity.
Measured: Baseline, Day 18
Change from baseline in Myasthenia Gravis Activities of Daily Life (MG-ADL) scale at day 32
The Myasthenia Gravis Activities of Daily Life (MG-ADL) is a questionnaire administered verbally that measures MG symptoms and functional activities related to activities of daily living. The summative total scores range from 0 to 24, with higher scores indicating greater disease severity.
Measured: Baseline, Day 32
Change from baseline in Myasthenia Gravis Manual Muscle Test (MG-MMT) at day 11
The Myasthenia Gravis Manual Muscle Test (MG-MMT) is an assessment that assigns numerical values to the presence of mild, moderate or severe weakness for specific muscle groups that may be affected by MG. The summative total scores range from 0 to 120, with higher scores indicating greater disease severity.
Measured: Baseline, Day 11
Change from baseline in Myasthenia Gravis Manual Muscle Test (MG-MMT) at day 18
The Myasthenia Gravis Manual Muscle Test (MG-MMT) is an assessment that assigns numerical values to the presence of mild, moderate or severe weakness for specific muscle groups that may be affected by MG. The summative total scores range from 0 to 120, with higher scores indicating greater disease severity.
Measured: Baseline, Day 18
Change from baseline in Myasthenia Gravis Manual Muscle Test (MG-MMT) at day 32
The Myasthenia Gravis Manual Muscle Test (MG-MMT) is an assessment that assigns numerical values to the presence of mild, moderate or severe weakness for specific muscle groups that may be affected by MG. The summative total scores range from 0 to 120, with higher scores indicating greater disease severity.
Measured: Baseline, Day 32
Change from baseline in Myasthenia Gravis Quality of Life-15 Revised (MG-QOL15r) at day 18
The Myasthenia Gravis Quality of Life-15 Revised (MG-QOL15r) is a scale that measures perceived limitations to fifteen different activities due to MG. Individual items are score 0 (not at all) to 4 (quite a bit). The summative total scores range from 0 to 60, with higher scores representing worse quality of life.
Measured: Baseline, Day 18
Change from baseline in Myasthenia Gravis Quality of Life-15 Revised (MG-QOL15r) at day 32
The Myasthenia Gravis Quality of Life-15 Revised (MG-QOL15r) is a scale that measures perceived limitations to fifteen different activities due to MG. Individual items are score 0 (not at all) to 4 (quite a bit). The summative total scores range from 0 to 60, with higher scores representing worse quality of life.
Measured: Baseline, Day 32
Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 4
The Quantitative Myasthenia Gravis (QMG) is a scoring system that quantifies disease severity by measuring ocular, bulbar, respiratory and limb strength. The total scores range from 0 to 39, with higher scores indicating greater disease severity.
Measured: Baseline, Day 4
Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 32
The Quantitative Myasthenia Gravis (QMG) is a scoring system that quantifies disease severity by measuring ocular, bulbar, respiratory and limb strength. The total scores range from 0 to 39, with higher scores indicating greater disease severity.
Measured: Baseline, Day 32
Postinterventional status at day 11
Postinterventional status is an assessment of whether a participant's MG symptoms/signs have remained unchanged, worsened, improved or reached minimal manifestations or minimal symptom expression.
Measured: Day 11
Postinterventional status at day 18
Postinterventional status is an assessment of whether a participant's MG symptoms/signs have remained unchanged, worsened, improved or reached minimal manifestations or minimal symptom expression.
Measured: Day 18
Postinterventional status at day 32
Postinterventional status is an assessment of whether a participants's MG symptoms/signs have remained unchanged, worsened, improved or reached minimal manifestations or minimal symptom expression.
Measured: Day 32
Length of hospital stay
Length of time between the participant being admitted to discharged. For participants transferred to University of Colorado Hospital, the time of admission/presentation to the outside hospital is counted.
Measured: Duration of hospitalization, approximately 7 days
Proportion of participants requiring mechanical ventilation
Number of participants requiring mechanical ventilation against the total number of participants.
Measured: During hospitalization, approximately 7 days
Proportion of participants requiring enteral feeding
Number of participants requiring enteral feeding (such as an NG tube or PEG tube) against the total number of participants.
Measured: During hospitalization, approximately 7 days
Time to freedom from respiratory support
Length of time between the participant being put on respiratory support (e.g. ventilator, BiPAP) and respiratory support being discontinued.
Measured: During hospitalization, approximately 7 days
Change from baseline in Total Immunoglobin G (IgG) at day 32
Immunoglobin G (IgG) total level will be measured via blood collection.
Measured: Baseline, Day 32
Change from baseline in Acetylcholine Receptor (AchR) antibody titer at day 32
Acetylcholine Receptor (AchR) antibody titer will be measured via blood collection.
Measured: Baseline, Day 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start6 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Myasthenia Gravis CrisisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- argenx
- Responsible party
- Sponsor
- Investigators
- Thomas Ragole, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860633
- Sponsor's protocol ID
- 24-0158
- Status last verified
- Jul 2025
- First submitted
- 28 Feb 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Phillips LH 2nd. The epidemiology of myasthenia gravis. Ann N Y Acad Sci. 2003 Sep;998:407-12. doi: 10.1196/annals.1254.053.
PubMed 14592908Schneider-Gold C, Hagenacker T, Melzer N, Ruck T. Understanding the burden of refractory myasthenia gravis. Ther Adv Neurol Disord. 2019 Mar 1;12:1756286419832242. doi: 10.1177/1756286419832242. eCollection 2019.
PubMed 30854027Gilhus NE. Myasthenia Gravis. N Engl J Med. 2016 Dec 29;375(26):2570-2581. doi: 10.1056/NEJMra1602678. No abstract available.
PubMed 28029925Habib AA, Sacks N, Cool C, Durgapal S, Dennen S, Everson K, Hughes T, Hernandez J, Phillips G. Hospitalizations and Mortality From Myasthenia Gravis: Trends From 2 US National Datasets. Neurology. 2024 Jan 23;102(2):e207863. doi: 10.1212/WNL.0000000000207863. Epub 2023 Dec 18.
PubMed 38165317Gajdos P, Chevret S, Toyka KV. Intravenous immunoglobulin for myasthenia gravis. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD002277. doi: 10.1002/14651858.CD002277.pub4.
PubMed 23235588Ipe TS, Davis AR, Raval JS. Therapeutic Plasma Exchange in Myasthenia Gravis: A Systematic Literature Review and Meta-Analysis of Comparative Evidence. Front Neurol. 2021 Aug 31;12:662856. doi: 10.3389/fneur.2021.662856. eCollection 2021.
PubMed 34531809Gelfand EW. Intravenous immune globulin in autoimmune and inflammatory diseases. N Engl J Med. 2012 Nov 22;367(21):2015-25. doi: 10.1056/NEJMra1009433. No abstract available.
PubMed 23171098Barth D, Nabavi Nouri M, Ng E, Nwe P, Bril V. Comparison of IVIg and PLEX in patients with myasthenia gravis. Neurology. 2011 Jun 7;76(23):2017-23. doi: 10.1212/WNL.0b013e31821e5505. Epub 2011 May 11.
PubMed 21562253Guo Y, Tian X, Wang X, Xiao Z. Adverse Effects of Immunoglobulin Therapy. Front Immunol. 2018 Jun 8;9:1299. doi: 10.3389/fimmu.2018.01299. eCollection 2018.
PubMed 29951056Norda R, Stegmayr BG; Swedish Apheresis Group. Therapeutic apheresis in Sweden: update of epidemiology and adverse events. Transfus Apher Sci. 2003 Oct;29(2):159-66. doi: 10.1016/S1473-0502(03)00121-6.
PubMed 12941356Kaya E, Keklik M, Sencan M, Yilmaz M, Keskin A, Kiki I, Erkurt MA, Sivgin S, Korkmaz S, Okan V, Dogu MH, Unal A, Cetin M, Altuntas F, Ilhan O. Therapeutic plasma exchange in patients with neurological diseases: multicenter retrospective analysis. Transfus Apher Sci. 2013 Jun;48(3):349-52. doi: 10.1016/j.transci.2013.04.015. Epub 2013 Apr 22.
PubMed 23619327Francois M, Daubin D, Menouche D, Gaillet A, Provoost J, Trusson R, Arrestier R, Hequet O, Richard JC, Moranne O, Larcher R, Klouche K. Adverse Events and Infectious Complications in the Critically Ill Treated by Plasma Exchange: A Five-Year Multicenter Cohort Study. Crit Care Explor. 2023 Oct 27;5(11):e0988. doi: 10.1097/CCE.0000000000000988. eCollection 2023 Nov.
PubMed 38304709Bril V, Szczudlik A, Vaitkus A, Rozsa C, Kostera-Pruszczyk A, Hon P, Bednarik J, Tyblova M, Kohler W, Toomsoo T, Nowak RJ, Mozaffar T, Freimer ML, Nicolle MW, Magnus T, Pulley MT, Rivner M, Dimachkie MM, Distad BJ, Pascuzzi RM, Babiar D, Lin J, Querolt Coll M, Griffin R, Mondou E. Randomized Double-Blind Placebo-Controlled Trial of the Corticosteroid-Sparing Effects of Immunoglobulin in Myasthenia Gravis. Neurology. 2023 Feb 14;100(7):e671-e682. doi: 10.1212/WNL.0000000000201501. Epub 2022 Oct 21.
PubMed 36270895Howard JF Jr, Bril V, Vu T, Karam C, Peric S, Margania T, Murai H, Bilinska M, Shakarishvili R, Smilowski M, Guglietta A, Ulrichts P, Vangeneugden T, Utsugisawa K, Verschuuren J, Mantegazza R; ADAPT Investigator Study Group. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2021 Jul;20(7):526-536. doi: 10.1016/S1474-4422(21)00159-9.
PubMed 34146511Gwathmey KG, Ding H, Hehir M, Silvestri N. How should newer therapeutic agents be incorporated into the treatment of patients with myasthenia gravis? Muscle Nerve. 2024 Apr;69(4):389-396. doi: 10.1002/mus.28038. Epub 2024 Feb 3.
PubMed 38308492
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod: A Single Arm, Open Label Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06860633
- Acronym / sponsor ID
- 24-0158
- Keywords
- myasthenia exacerbation, efgartigimod
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- argenx
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive but has not been studied in the treatment of worsening weakness requiring hospital admission (known as "exacerbation"). This investigation aims to see if using efgartigimod in this way improves symptoms and recovery from exacerbation, and how it affects certain MG markers in the blood. The main questions it aims to answer are:
- Is efgartigimod effective as a hospital-administered acute therapy for participants with worsening MG (MG exacerbation) who require hospitalization?
- Will efgartigimod lead to clinical improvement with a similar reduction in validated research scales, such as the Quantitative MG (QMG) scale, as standard of care therapies?
Participants will receive 4 doses of efgartigimod over the course of 4 weeks with an additional follow-up visit at the clinic.
Detailed description
Efgartigimod is thought to work by reducing circulating IgG antibodies, including the antibodies that cause MG. One of the currently used treatments for MG exacerbation, called plasma exchange (PLEX), is also thought to work by reducing antibody levels by filtering blood through a machine similar to those used in dialysis for kidney failure. Because of the similarities between how these two treatments work, there is reason to believe that efgartigimod may also be helpful in treating MG exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod | Experimental | Drug: EfgartigimodParticipants receive 4 doses of efgartigimod via intravenous (IV) infusion over the course of the study on days 1, 4, 11 and 18. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults ≥ age 18 years with known generalized MG as identified by characteristic signs of generalized MG on clinical assessment and positive serology for AchR antibodies as well as one of the following:
- Evidence of worsening weakness requiring hospital admission for stabilization and change in therapy as determined by a neuromuscular expert including:
- Ability to sign consent and be enrolled within 24 hours of hospital admission. For participants transferred to University of Colorado Hospital, the time of admission/presentation to the outside hospital is counted towards this 24-hour cap.
Key exclusion criteria (9 listed)
- MG worsening thought to be related to active infection or due to medications (e.g. fluoroquinolone or aminoglycoside antibiotics, magnesium, chloroquine derivatives)
- Intubation prior to ability to sign informed consent or intubation within 24 hours of hospitalization
- Use of IVIG within 2 weeks, or having undergone plasma exchange or received efgartigimod in the 4 weeks prior to admission
- Current ongoing use of ravulizumab or eculizumab (monoclonal antibody C5-complement inhibitors).
- Other medical conditions that, in the opinion of the investigator and treating clinicians, might interfere with the validity of assessment measures used in the study (e.g. steroid myopathy, CNS pathology, severe arthritis, fractures, etc.). This criterion is a standard exclusion in MG trials and relates solely to other conditions that reduce muscle power or range of motion and would thus worsen scores on assessment measures like the QMG due to non-MG conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EfgartigimodAlso: VyvgartDose of 10 mg/kg for IV infusion on days 1, 4, 11 and 18 | Drug | Efgartigimod |
Primary outcome
Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 11
Time frame: Baseline, Day 11
The Quantitative Myasthenia Gravis (QMG) is a scoring system that quantifies disease severity by measuring ocular, bulbar, respiratory and limb strength. The total scores range from 0 to 39, with higher scores indicating greater disease severity.
19 secondary outcomes
Percentage of participants requiring rescue therapy with Plasma Exchange (PLEX) or Intravenous Immunoglobulin (IVIG)
Time frame: During hospitalization, approximately 7 days
Change from baseline in Myasthenia Gravis Activities of Daily Life (MG-ADL) scale at day 18
Time frame: Baseline, Day 18
Change from baseline in Myasthenia Gravis Activities of Daily Life (MG-ADL) scale at day 32
Time frame: Baseline, Day 32
Change from baseline in Myasthenia Gravis Manual Muscle Test (MG-MMT) at day 11
Time frame: Baseline, Day 11
Change from baseline in Myasthenia Gravis Manual Muscle Test (MG-MMT) at day 18
Time frame: Baseline, Day 18
Change from baseline in Myasthenia Gravis Manual Muscle Test (MG-MMT) at day 32
Time frame: Baseline, Day 32
Change from baseline in Myasthenia Gravis Quality of Life-15 Revised (MG-QOL15r) at day 18
Time frame: Baseline, Day 18
Change from baseline in Myasthenia Gravis Quality of Life-15 Revised (MG-QOL15r) at day 32
Time frame: Baseline, Day 32
Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 4
Time frame: Baseline, Day 4
Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 32
Time frame: Baseline, Day 32
Postinterventional status at day 11
Time frame: Day 11
Postinterventional status at day 18
Time frame: Day 18
Postinterventional status at day 32
Time frame: Day 32
Length of hospital stay
Time frame: Duration of hospitalization, approximately 7 days
Proportion of participants requiring mechanical ventilation
Time frame: During hospitalization, approximately 7 days
Proportion of participants requiring enteral feeding
Time frame: During hospitalization, approximately 7 days
Time to freedom from respiratory support
Time frame: During hospitalization, approximately 7 days
Change from baseline in Total Immunoglobin G (IgG) at day 32
Time frame: Baseline, Day 32
Change from baseline in Acetylcholine Receptor (AchR) antibody titer at day 32
Time frame: Baseline, Day 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 14592908Phillips LH 2nd. The epidemiology of myasthenia gravis. Ann N Y Acad Sci. 2003 Sep;998:407-12. doi: 10.1196/annals.1254.053.
- Background: PubMed 30854027Schneider-Gold C, Hagenacker T, Melzer N, Ruck T. Understanding the burden of refractory myasthenia gravis. Ther Adv Neurol Disord. 2019 Mar 1;12:1756286419832242. doi: 10.1177/1756286419832242. eCollection 2019.
- Background: PubMed 28029925Gilhus NE. Myasthenia Gravis. N Engl J Med. 2016 Dec 29;375(26):2570-2581. doi: 10.1056/NEJMra1602678. No abstract available.
- Background: PubMed 38165317Habib AA, Sacks N, Cool C, Durgapal S, Dennen S, Everson K, Hughes T, Hernandez J, Phillips G. Hospitalizations and Mortality From Myasthenia Gravis: Trends From 2 US National Datasets. Neurology. 2024 Jan 23;102(2):e207863. doi: 10.1212/WNL.0000000000207863. Epub 2023 Dec 18.
- Background: PubMed 23235588Gajdos P, Chevret S, Toyka KV. Intravenous immunoglobulin for myasthenia gravis. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD002277. doi: 10.1002/14651858.CD002277.pub4.
- Background: PubMed 34531809Ipe TS, Davis AR, Raval JS. Therapeutic Plasma Exchange in Myasthenia Gravis: A Systematic Literature Review and Meta-Analysis of Comparative Evidence. Front Neurol. 2021 Aug 31;12:662856. doi: 10.3389/fneur.2021.662856. eCollection 2021.
- Background: PubMed 23171098Gelfand EW. Intravenous immune globulin in autoimmune and inflammatory diseases. N Engl J Med. 2012 Nov 22;367(21):2015-25. doi: 10.1056/NEJMra1009433. No abstract available.
- Background: PubMed 21562253Barth D, Nabavi Nouri M, Ng E, Nwe P, Bril V. Comparison of IVIg and PLEX in patients with myasthenia gravis. Neurology. 2011 Jun 7;76(23):2017-23. doi: 10.1212/WNL.0b013e31821e5505. Epub 2011 May 11.
- Background: PubMed 29951056Guo Y, Tian X, Wang X, Xiao Z. Adverse Effects of Immunoglobulin Therapy. Front Immunol. 2018 Jun 8;9:1299. doi: 10.3389/fimmu.2018.01299. eCollection 2018.
- Background: PubMed 12941356Norda R, Stegmayr BG; Swedish Apheresis Group. Therapeutic apheresis in Sweden: update of epidemiology and adverse events. Transfus Apher Sci. 2003 Oct;29(2):159-66. doi: 10.1016/S1473-0502(03)00121-6.
- Background: PubMed 23619327Kaya E, Keklik M, Sencan M, Yilmaz M, Keskin A, Kiki I, Erkurt MA, Sivgin S, Korkmaz S, Okan V, Dogu MH, Unal A, Cetin M, Altuntas F, Ilhan O. Therapeutic plasma exchange in patients with neurological diseases: multicenter retrospective analysis. Transfus Apher Sci. 2013 Jun;48(3):349-52. doi: 10.1016/j.transci.2013.04.015. Epub 2013 Apr 22.
- Background: PubMed 38304709Francois M, Daubin D, Menouche D, Gaillet A, Provoost J, Trusson R, Arrestier R, Hequet O, Richard JC, Moranne O, Larcher R, Klouche K. Adverse Events and Infectious Complications in the Critically Ill Treated by Plasma Exchange: A Five-Year Multicenter Cohort Study. Crit Care Explor. 2023 Oct 27;5(11):e0988. doi: 10.1097/CCE.0000000000000988. eCollection 2023 Nov.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Evaluation of the Condition of Patients Receiving EARLY Ravulizumab and Admitted in ICU for gMG Crisis
Myasthenia Gravis
RecruitingObservational study
AXIS MG Patient Registry
Myasthenia Gravis (MG), Myasthenia Gravis, Generalized
Not yet recruitingPhase 4
Intravenous Human IgG1 Fc Fragment (Efgartigimod) in Myasthenic Crisis
Myasthenia Gravis Crisis
RecruitingObservational study
Myasthenia Gravis Foundation of America Global MG Patient Registry
Myasthaenia Gravis, Myasthenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Ragole, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efgartigimod in people with Myasthenia Gravis Crisis and Myasthenia Gravis Exacerbations, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyssa Avilez, BS (303.724.3522, alyssa.avilez@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 11 (time frame: Baseline, Day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06860633, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.