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- A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITH OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF INEBILIZUMAB IN ADULTS WITH MYASTHENIA GRAVIS
Clinical Trial
A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITH OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF INEBILIZUMAB IN ADULTS WITH MYASTHENIA GRAVIS
The purpose of this study is to determine whether the investigational drug inebilizumab is safe and effective in reducing the symptoms of myasthenia gravis. The effect that inebilizumab has on your myasthenia gravis will be assessed by recording the state of your disease (worse, better, stable), whether you need more treatment for myasthenia gravis, how you feel about your health, and other measures of whether the drug might be working to prevent flares (activity) of myasthenia gravis. The study will also assess side effects?both those that you report and those that might be measured in your lab tests--and whether your body makes antibodies against inebilizumab.
Eligibility Criteria
- Inclusion Criteria: You have a diagnosis of generalized MG with a positive test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific kinase (MuSK) antibodies, and at least one of the following: history of abnormal single-fiber electromyography (SFEMG) or repetitive nerve stimulation; or history of positive anticholinesterase test; or improvement in MG signs on oral cholinesterase inhibitors; symptoms consistent with a diagnosis of MG and not explained by another condition. Exclusion Criteria: You have had a thymectomy within the last 12 months or plan to have a thymectomy while in the study. You have a thymoma that has not been surgically removed. You have a history of cancer within the last 5 years
RESEARCH. INNOVATION. DISCOVERY.