Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
11 participants
OBSERVATIONAL
2013-07-31
2014-10-31
Brief Summary
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Detailed Description
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Ten (10) AChR antibody positive MG subjects will be enrolled in the study at 2 sites. Of these 10 MG subjects, up to 5 may be receiving chronic TPE.
The study period will be approximately 3 months and will consist of:
* Screening/baseline visit,
* TPE visit where subjects will undergo clinical evaluations and blood draws for immunological assays,
* End of TPE visit where information on the TPE procedure will be recorded, clinical measurements will be performed, and a blood sample will be drawn.
* Post-TPE period where subjects will undergo clinical evaluations and blood draws for immunological assays at week 1, week 2, week 3, week 6, and week 12 after TPE.
Study procedures performed outside of usual care will include optional single-fiber electromyography (SFEMG) studies, blood draws and optional skin biopsies.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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MG subjects
MG subjects will have serum acetylcholine receptor (AChR) antibodies
Skin biopsy
An optional skin biopsy will be performed in up to 5 subjects at baseline and 2 weeks after therapeutic plasma exchange is completed.
Single Fiber Electromyography
An optional SFEMG study will be performed at baseline and 2 weeks after therapeutic plasma exchange is completed.
Interventions
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Skin biopsy
An optional skin biopsy will be performed in up to 5 subjects at baseline and 2 weeks after therapeutic plasma exchange is completed.
Single Fiber Electromyography
An optional SFEMG study will be performed at baseline and 2 weeks after therapeutic plasma exchange is completed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* diagnosis of MG based on clinical features
* has detectable serum autoantibodies to AChR
* has a clinical indication for the use of TPE to treat MG
Exclusion Criteria
* weighs less than 50Kg
* has a contraindication to treatment with TPE (e.g. clinically significant bleeding disorder)
* has muscle specific tyrosine kinase or low-density lipoprotein receptor-related protein 4 (LRP4) antibody positive MG
* has prior or current history of thymoma
* had a thymectomy in the past 6 months
* has received rituximab in the past 12 months
* has another coexisting autoimmune disease that is not clinically controlled or may preclude accurate study assessments according to the judgment of the PI
* has current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or central nervous system disease
* has participated in an interventional clinical trial with a novel therapeutic agent in the past 6 months
* is cognitively impaired, a prisoner, or otherwise institutionalized at the time of screening
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Guptill, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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UNC Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00043906
Identifier Type: -
Identifier Source: org_study_id
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