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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) (REAL MG PRO)

2026년 8월 31일 업데이트: Centre Hospitalier Universitaire de Nice

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.

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

50

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 프랑스
      • Angers, 프랑스, 49933
        • 아직 모집하지 않음
        • CHU d'Angers
        • 연락하다:
      • Boulogne-sur-Mer, 프랑스, 62231
        • 아직 모집하지 않음
        • Ch de Boulogne sur Mer
        • 연락하다:
      • Créteil, 프랑스, 94000
        • 아직 모집하지 않음
        • Hopital Henri Mondor
        • 연락하다:
          • Edoardo MALFATTI, PU-PH
          • 전화번호: +33149812111
      • Garches, 프랑스, 92380
        • 아직 모집하지 않음
        • Hôpital Raymond Pointcarré
        • 연락하다:
      • Grenoble, 프랑스, 38700
      • Lille, 프랑스, 59037
        • 아직 모집하지 않음
        • CHU de Lille
        • 연락하다:
      • Lille, 프랑스, 59000
        • 아직 모집하지 않음
        • GHICL Saint Vincent de Paul
        • 연락하다:
      • Limoges, 프랑스, 87042
        • 아직 모집하지 않음
        • Chu Dupuytren 1
        • 연락하다:
      • Rouen, 프랑스, 76031
        • 아직 모집하지 않음
        • CHU Charles Nicolle
        • 연락하다:
      • Toulouse, 프랑스, 31059
        • 아직 모집하지 않음
        • CHU de Toulouse
        • 연락하다:
    • Alpes-maritimes
      • Nice, Alpes-maritimes, 프랑스, 06000
        • 모병
        • Chu De Nice
        • 연락하다:
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Patients affected by generalized Myasthenia Gravis with anti-AChR and anti-MUSK and treated with ROZ

설명

Inclusion Criteria:

  • 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);
  • 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.

Exclusion Criteria:

  • 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;
  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 7 days after the end of every cycle of treatment for 9 months
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)
7 days after the end of every cycle of treatment for 9 months

2차 결과 측정

결과 측정
측정값 설명
기간
Evaluate the impact of real life on MG symptoms PRO global sub-scores physical fatigue
기간: 7 days after the end of every cycle of treatment for 9 months
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)
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
기간: 7 days after the end of every cycle of treatment for 9 months
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)
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)
기간: 7 days after the end of every cycle of treatment for 9 months
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)
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
기간: 7 days after the end of every cycle of treatment for 9 months
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)
7 days after the end of every cycle of treatment for 9 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Centre Hospitalier Universitaire de Nice

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 15일

기본 완료 (추정된)

2028년 3월 1일

연구 완료 (추정된)

2028년 3월 1일

연구 등록 날짜

최초 제출

2026년 4월 30일

QC 기준을 충족하는 최초 제출

2026년 4월 30일

처음 게시됨 (실제)

2026년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 31일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 25-PP-23

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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