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Completed

NCT Number: NCT01927692

Therapeutic Plasma Exchange in MG

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).

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Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Chapel Hill, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • has the capacity to understand and sign an informed consent form
  • 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

  • unable or unwilling to comply with study procedures that include multiple venipunctures
  • 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

Treatment and study plan

Skin biopsy

Other

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

Other

An optional SFEMG study will be performed at baseline and 2 weeks after therapeutic plasma exchange is completed.

Other names: SFEMG

Primary outcomes

  1. Immunoglobulin levels

    Time frame: 14 weeks

    Immunoglobulin and IgG subtype levels, AChR autoantibody levels, IgG/autoantibody ratio will be listed, summarized and plotted graphically by visit.

Secondary outcomes

  1. Lymphocyte subpopulations

    Time frame: 14 weeks

    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.

  2. SFEMG

    Time frame: 14 weeks

    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).

  3. Vaccination/protective antibodies

    Time frame: 14 weeks

    The time course for recovery of selected protective antibody levels removed during TPE will be summarized.

  4. Clinical Outcomes Assessments

    Time frame: 14 weeks

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • UCB Pharma

Registry information

Official study title

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

Acronym: TPE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2013
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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