Health TrialsbyHealthPanel

Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis

ConditionsGeneralized Myasthenia GravisAnti-AChR Antibody Positive
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlexion Pharmaceuticals, Inc.

About this trial

The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of a positive serologic test for anti-AChR antibodies, and

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

Disqualifiers

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

Trial population

Patients with anti-AChR antibody positive, generalized, myasthenia gravis elegible to Ravulizumab treatment with a disease duration from onset equal or less than 3 years.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ravulizumab

    Drug

    Participants will receive Ravulizumab.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Ravulizumab1 intervention

Trial outcomes

Primary outcomes

1

Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 50

Time frame
Week 50
2

Change From Baseline in MG-ADL Total Score at Week 50

Time frame
Baseline, Week 50

Secondary outcomes

1

MG-ADL Total Score at Weeks 2, 10, and 26

Time frame
Weeks 2, 10, and 26
2

Change From Baseline in MG-ADL Total Score at Weeks 2, 10 and 26

Time frame
Baseline, Weeks 2, 10 and 26
3

Percentage of Participants With >=2- Point Reduction From Baseline in MG-ADL Total Score at Weeks 2, 10, 26, and 50

Time frame
Baseline, Weeks 2, 10, 26, and 50
4

Quantitative Myasthenia Gravis (QMG) Total Score at Weeks 2, 10, 26, and 50

Time frame
Weeks 2, 10, 26, and 50

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexion Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now