Therapeutic Plasma Exchange in MG (TPE)
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).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Exploratory Study Of Immunological Profiles In Myasthenia Gravis Subjects That Receive Therapeutic Plasma Exchange|
- Immunoglobulin levels [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]Immunoglobulin and IgG subtype levels, AChR autoantibody levels, IgG/autoantibody ratio will be listed, summarized and plotted graphically by visit.
- Lymphocyte subpopulations [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]Peripheral blood mononuclear cells (PBMC) will be analyzed using highly standardized polychromatic flow cytometric techniques for the expression of a broad array of phenotypic markers. A B-cell and T-cell panel will be used to profile specific marker expression among PBMCs and define lymphocyte subpopulations.
- SFEMG [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]The extensor digitorum communis muscle will be studied in every subject and the muscle tested must have increased jitter at the initial study. If examination of the extensor digitorum communis is not feasible or the jitter is normal at the initial study, the muscle to study will be at the discretion of the investigator performing the SFEMG test, preferably frontalis. In each SFEMG study, jitter from 20 paired muscle fiber potentials will be recorded whenever feasible. Recorded variables will include total number of muscle fiber pairs studied, abnormal muscle fiber pairs, blocking pairs, and mean consecutive difference (MCD).
- Vaccination/protective antibodies [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]The time course for recovery of selected protective antibody levels removed during TPE will be summarized.
- Clinical Outcomes Assessments [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]All clinical outcomes assessments data (MG-Composite, MG-ADL, MG-QOL-15, MG-MMT) will be listed and summarized by visit. Scores may be presented graphically. Immunological measurements will be correlated with clinical scores, if appropriate.
|Study Start Date:||July 2013|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
MG subjects will have serum acetylcholine receptor (AChR) antibodies
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.
Other Name: SFEMG
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01927692
|United States, North Carolina|
|UNC Chapel Hill|
|Chapel Hill, North Carolina, United States|
|Duke University Hospital|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Jeffrey Guptill, MD||Duke University|