Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis
ConditionMyasthenia Gravis, Generalized
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTang-Du Hospital
About this trial
Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.
Eligibility criteria
Qualifiers
Diagnosis of MG with anti-AChRantibody.
MGFA Clinical Classification Class II, III, or IV.
MG-ADL score of 5 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.
QMG score of 11 or greater.
Disqualifiers
Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the 4 weeks before randomization;
Those with a history of high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis;
Human immunodeficiency virus (HIV) infection;
Thymomas that have received thymectomy or planned thymectomy during RCP within 6 months before randomization, or require chemotherapy and/or radiotherapy at any time;
Trial design
Treatments tested in this trial
- Tocilizumab Injectable Product
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov