Clinical trial · Observational
Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
MG-EVOLUTION. Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis: A Real-World Study With Biomarker Analysis
NCT06967480CI-TRIAL-00102522recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti-AChR Antibody Positive | — | UNRESOLVED | — |
| Generalized Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ravulizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ravulizumab
- description
- Participants will receive Ravulizumab until Week 50 ± 14 days after baseline or until discontinuation.
- interventionNames
- Drug: Ravulizumab
Primary outcomes (2)
- measure
- Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 50
- timeFrame
- Week 50
- measure
- Change From Baseline in MG-ADL Total Score at Week 50
- timeFrame
- Baseline, Week 50
Secondary outcomes (24)
- measure
- MG-ADL Total Score at Weeks 2, 10, and 26
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of MG confirmed by:
* History of a positive serologic test for anti-AChR antibodies, and
* One of the following:
* History of abnormal neuromuscular transmission test demonstrated by singlefibre electromyography or repetitive nerve stimulation
* History of positive anticholinesterase test (e.g., edrophonium chloride test); or
* Patient demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician
* Disease duration from MG onset ≤ 3 years before T-4 (Enrolment);
* MGFA class IIb to IV;
* Patient eligible for Ravulizumab treatment based on AIFA reimbursement criteria
* Vaccination cycle for Neisseria meningitidis completed at least two weeks before Ravulizumab initiation or antibiotics chemoprophylaxis according to the SmPC.
Exclusion Criteria:
* Patient unable to understand and sign the informed consent
* Hypersensitivity to the active substance or to any of the excipients of the study product
* Patient for whom the study product is contraindicated according to SmPC
* Previous treatment with C5 inhibitors
* Last rituximab infusion performed \< 6 months before T-4 (Enrolment)
* Last infusion with FcRn blockers performed \< 3 months before T-4 (Enrollment)
* Pregnant or lactating or planning a pregnancy during the study
* Patient who plan to relocate during the study
* Patient who are unsure of following the visit schedule
* Patient unable to complete questionnaires
* Previous or current participation to other interventional studiesReferences
Publications (0)
Data not yet available
No reference posted for this study.