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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03059888
Date of registration: 17/02/2017
Prospective Registration: Yes
Primary sponsor: Johns Hopkins University
Public title: Trial of Orencia in Patients With Myasthenia Gravis
Scientific title: Pilot Trial of Orencia in Myasthenia Gravis Patients Inadequately Responsive to Conventional Immunotherapy
Date of first enrolment: April 12, 2017
Target sample size: 6
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT03059888
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Early Phase 1
Countries of recruitment
United States
Contacts
Name:     Daniel Drachman, MD
Address: 
Telephone:
Email:
Affiliation:  Johns Hopkins University
Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Myasthenia Gravis
Intervention(s)
Drug: Abatacept Injection
Primary Outcome(s)
Muscle Strength (Dynamometry) [Time Frame: 12 months]
Objective Composite Score of Myasthenia Gravis (MG) Severity [Time Frame: 12 months]
Subjective Composite Score of Myasthenia Gravis (MG) Severity [Time Frame: 12 months]
Secondary Outcome(s)
Acetylcholine Receptor (AChR) or Muscle-Specific Kinase (MuSK) Antibody Concentrations [Time Frame: 12 months]
Myasthenia Gravis Composite Score (MGC) [Time Frame: 12 months]
Myasthenia Gravis Quality of Life-15 (MG QOL15) Score [Time Frame: 12 months]
Secondary ID(s)
IRB00100059
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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