Trial of Orencia in Patients With Myasthenia Gravis
Trial of Orencia in Patients With Myasthenia Gravis
This pilot research study is being done to see if the drug abatacept (Orencia ®) will be
 helpful in treating patients with myasthenia gravis (MG) who do not respond satisfactorily to
 other drugs that are used to suppress the immune system. Abatacept has been successful in
 treating experimental MG in laboratory animals, and this study is to determine its
 effectiveness in patients with MG.
Inclusion Criteria:

 -  Able to comprehend and willing to sign an Informed Consent Form (ICF)

 -  Male or female 16 to 85 years of age

 -  Diagnosis of DEFINITE Myasthenia Gravis

 -  History of inadequate response to conventional MG treatment

 -  Clinical laboratory findings within the normal range or, if outside the normal range,
 deemed not clinically significant by the Investigator

 -  Female patients of childbearing potential who are not be breastfeeding, have a
 negative pregnancy test, have no intention to become pregnant during the course of the
 study, and are using contraceptive drugs or devices to prevent pregnancy during their
 participation in the study

 -  Willing to cooperate with study requirements, including visits to the study site every
 2 months.

 Exclusion Criteria:

 -  Subject's MG is responding adequately to conventional immunosuppressive treatment

 -  Subject has had no previous trial of other immunosuppressive agents

 -  Subject has a history of Chronic Obstructive Pulmonary Disease (COPD)

 -  Subject is impaired, incapacitated or incapable of completing study-related
 assessments

 -  Subject has the presence at screening of any severe, progressive or uncontrolled
 renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic or
 cerebral disease, whether or not related to MG that, in the opinion of the
 Investigator, might place the subject at unacceptable risk for participation in the
 study.

 -  Female subject has a history of breast cancer screening that is suspicious for
 malignancy and in whom the possibility of malignancy cannot be reasonably excluded by
 additional clinical, laboratory or other diagnostic evaluations

 -  Subject has a history of cancer in the last 5 years, other than non-melanoma skin cell
 cancers cured by local resection or carcinoma in situ

 -  Subject currently abuses drugs or alcohol

 -  Subject has evidence of active or latent bacterial or viral infections, including
 positive infectious disease laboratory test result (Hepatitis B, Hepatitis C or HIV)

 -  Subject has history of herpes zoster or cytomegalovirus (CMV) infection that resolved
 less than 2 months prior to screening visit

 -  Subject has received any live vaccine within 3 months of screening

 -  Subject has a history of serious bacterial infection within in the last 3 months,
 unless treated and resolved with antibiotics; or, any chronic bacterial infection

 -  Subject is at risk for tuberculosis

 -  Subject has any of the following laboratory values: Hemoglobin < 8.5 g/dL; White Blood
 Cells (WBC) < 3000 mm3; Platelets < 100,000 mm3; Serum creatinine > 2x upper limit of
 normal (ULN); Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)
 > 2x ULN

 -  Subject is unable or unwilling to maintain weekly injection schedule

 -  Subject has undergone a change in immunosuppressive medications within the last three
 months prior to enrollment.

 -  Subject has neurological impairment due to a condition other than MG, including
 history of transient ischemic attack within the past year

 -  Subject has taken any investigational study drug within 28 days or five half-lives of
 the prior agent, whichever is greater, prior to dosing

 -  Subject has had previous exposure to Orencia (abatacept)

 -  Subject is a prisoner or is involuntarily incarcerated

 -  Subject is compulsorily detained for treatment of either psychiatric or physical
 illness

 -  Subject is judged to be actively suicidal or a suicide risk by the Investigator