Generalized Myasthenia GravisREAL MG PRONCT07570589
Monitor the Evolution of Myasthenia Gravis Symptoms in Real-life in Patients With Anti-AChR and Anti-MUSK Generalised Myasthenia Gravis in Therapy With RYSTIGGO® (Rozanolixizumab)
An observational study of Generalized Myasthenia Gravis, run by Centre Hospitalier Universitaire de Nice at 11 sites in France.
Trial summary
Generalized Myasthenia Gravis (gMG) is a rare autoimmune disease (a disease in which the body attacks its own tissues) that causes muscle weakness and significant fatigue. Current treatments (corticosteroids, plasma exchange, intravenous immunoglobulin infusions) improve symptoms in many patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- Patients diagnosed with generalized myasthenia gravis and treated with Rozanolixizumab
- How many people
- 50 participants
- Where
- 11 sitesFrance
- Study dates
- 15 Jun 2026to Mar 2028
- Phase
- Observational
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
Study population: Patients affected by generalized Myasthenia Gravis with anti-AChR and anti-MUSK and treated with ROZ
Who may be able to join
- Male or female subjects aged ≥18 years;
- Diagnosed with MG with confirmed documentation and supported by a physical exam and confirmed seropositivity for anti AChR or anti MUSK antibodies;
- Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MFGA) for generalized MG class IIa, IIb, IIIa, and IIIb;
- Patient suitable for ROZ treatment (IgG ≥ 5,5 g/l);
- Patient naïve for ROZ treatment, or receiving the last dose more than 3 months prior inclusion;
- MG-ADL score ≥ 3 (with ≥ 3 points of non-ocular symptoms);
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- Patient must have received all mandatory vaccinations according to local regulations prior to study enrollment;
- Capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent;
- Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures;
- Patient affiliated to a European social security system.
Who cannot join
- Any current mental condition (psychiatric disorder, senility, or dementia) that, in the opinion of the investigator, may affect study compliance or prevent understanding of the aims, investigational procedures, or possible consequences of the study; and/or patient with a Mini-mental State evaluation (MMSE) of <25;
- History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject;
- History of ongoing malignancy (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured);
- Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at inclusion;
- Patient receiving concomitant treatment with rituximab, anti-FcRn, complement inhibitors and/or PLEX;
- Patients discontinued from rituximab without respecting the administration rules of ROZ;
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- Patient with end-stage diseases or with a disease that will enable him to be evaluated and/or treated;
- Patients with non-treated active infections;
- Patients with hypersensitivity to the active substance(s) or to any of the excipients, specifically: histidine, histidine hydrochloride monohydrate, proline, polysorbate 80, or water for injections.
- Subject, or close relative of the subject, is the investigator or a sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study at that site;
- Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
CHu d'Angers
Angers, 49933
Marco Spinazzi, PH, +33241357933, marco.spinazzi@chu-angers.fr
- Not yet recruiting
Ch de Boulogne sur Mer
Boulogne-sur-Mer, 62231
Mathieu BATAILLE, PH, +321993056, m.bataille@ch-boulogne.fr
- Not yet recruiting
Hôpital Henri Mondor
Créteil, 94000
Edoardo MALFATTI, PU-PH, +33149812111
- Not yet recruiting
Hôpital Raymond Pointcarré
Garches, 92380
Diane FRIEDMAN, PH, +33147107785, friedman.diane@aphp.fr
- Not yet recruiting
CHU de Grenoble
Grenoble, 38700
Emmeline LAGRANGE, PH, elagrange@chu-grenoble.fr
- Not yet recruiting
GHICL Saint Vincent de Paul
Lille, 59000
Julien Poupart, PH, +33320874901, poupart.julien@ghicl.net
- Not yet recruiting
CHU de LILLE
Lille, 59037
Céline TARD, PH, +330320444145, celine.tard@chu-lille.fr
- Not yet recruiting
Chu Dupuytren 1
Limoges, 87042
Laurent MAGY, PU-PH, +33555056561, laurent.magy@unlim.fr
- Recruiting
CHU de NICE
Nice, Alpes-maritimes, 06000
Sabrina SACCONI, pu-ph, +33 4 92 03 57 57, sacconi.s@chu-nice.fr
Sabrina SACCONI, 0492035757, sacconi.s@chu-nice.fr
- Not yet recruiting
CHU Charles Nicolle
Rouen, 76031
Anne-Laure BEDAT-MILLET, PH, +33232885721, anne-laure.millet@chu-rouen.fr
- Not yet recruiting
CHU de Toulouse
Toulouse, 31059
Blandine Acket, PH, +33561779989, acket.b@chu-toulouse.fr
About this study
Official title: An Observational, Prospective, Multicenter, Open-label Study to Monitor the Evolution of Myasthenia Gravis Symptoms in Real-life in Patients With Anti-AChR and Anti-MUSK Generalised Myasthenia Gravis in Therapy With RYSTIGGO® (Rozanolixizumab)
Generalized Myasthenia Gravis (gMG) is a rare autoimmune disease (a disease in which the body attacks its own tissues) that causes muscle weakness and significant fatigue.
Current treatments (corticosteroids, plasma exchange, intravenous immunoglobulin infusions) improve symptoms in many patients. However, many continue to suffer from fatigue and fatigability that are not well measured by standard tools. Moreover, these treatments can cause significant long-term side effects, reducing quality of life.
Read more
New treatments such as Rozanolixizumab (ROZ) are now available. They act rapidly and are well tolerated, allowing better symptom control while reducing the risks associated with conventional treatments.
To properly evaluate these new treatments, it is essential to understand patients' perspectives on their effectiveness. The scales used by physicians do not always capture all the symptoms experienced by patients, particularly fatigability. This is why a new tool has been developed: the MG symptoms PRO. This questionnaire allows patients to assess their own symptoms (fatigue, weakness of the eyes, mouth, breathing, muscle fatigability) in detail.
This research aims to better understand the effectiveness of treatments from the patients' perspective in order to improve their care.
The goal of the study is to evaluate the impact of Rozanolixizumab administration in real-world practice through the MG symptoms PRO questionnaire. This is an observational study, meaning that the medication is prescribed by the physician according to current regulations, and the study simply collects routine medical data during your follow-up, over a period of approximately 9 months.
- Conditions
- Generalized Myasthenia Gravis
- Being tested
- Patients diagnosed with generalized myasthenia gravis and treated with Rozanolixizumab
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients diagnosed with generalized myasthenia gravis and treated with RozanolixizumabOther
Patients are evaluated using the MG Symptoms PRO questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess in real-life the impact of the ROZ on MG symptoms PRO score in generalized MG patients with anti-AChR or anti-MUSK antibodies
To monitor 7 days after the end of every cycle of treatment for 9 months the change from baseline of MG symptoms PRO score (frome non to severe)
Measured: 7 days after the end of every cycle of treatment for 9 months
Secondary outcomes (4)
Evaluate the impact of real life on MG symptoms PRO global sub-scores physical fatigue
To monitor 7 days after the end of every cycle of treatment for 9 months the change from baseline of MG symptoms PRO sub-score physical fatigue (from none of the time to all the time)
Measured: 7 days after the end of every cycle of treatment for 9 months
Evaluate the impact of real life on quality of life measured by MG-QOL15r
To monitor 7 days after the end of every cycle of treatment for 9 months the change from baseline of MG-QOL15r (MYASTHENIA GRAVIS QUALITY OF LIFE 15 REVISED) (from not at all to very much)
Measured: 7 days after the end of every cycle of treatment for 9 months
Evaluate the impact of real life on patient general state, measured by the Patient-Acceptable Symptom State (PASS)
To monitor 7 days after the end of every cycle of treatment for 9 months the change from baseline of PASS (PATIENT-ACCEPTABLE SYMPTOM STATE)
Measured: 7 days after the end of every cycle of treatment for 9 months
Evaluate the impact of real life on the evolution of gMG after each cycle measured by MG-ADL score
To monitor 7 days after the end of every cycle of treatment for 9 months the change from baseline of MG-ADL score (MYASTHENIA GRAVIS ACTIVITIES OF DAILY LIVING) (from normal to most severe)
Measured: 7 days after the end of every cycle of treatment for 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start15 Jun 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570589
- Sponsor's protocol ID
- 25-PP-23
- Acronym
- REAL MG PRO
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No