Therapeutic Plasma Exchange in MG — TPE  

Myasthenia Gravis Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myasthenia Gravis

• NCT number: NCT01927692
• Study type: Observational
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Completion date: October 2014