NCT01927692

Therapeutic Plasma Exchange in MG

Exploratory Study Of Immunological Profiles In Myasthenia Gravis Subjects That Receive Therapeutic Plasma Exchange

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to longitudinally profile immunoglobulin levels and autoantibody levels in subjects with myasthenia gravis (MG) who receive therapeutic plasma exchange (TPE).

Detailed description

This is a prospective, multi-center, pilot biomarker study in subjects receiving TPE for the treatment of MG. No study medications will be given. 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

• Myasthenia Gravis

Interventions

Type	Name	Description
OTHER	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.
OTHER	Single Fiber Electromyography	An optional SFEMG study will be performed at baseline and 2 weeks after therapeutic plasma exchange is completed.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-08-23
• Last updated: 2015-07-16

Locations

2 sites across 1 country: United States