Clinical trial · Observational
Therapeutic Plasma Exchange in MG
Exploratory Study Of Immunological Profiles In Myasthenia Gravis Subjects That Receive Therapeutic Plasma Exchange
NCT01927692CI-TRIAL-00018568TPEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single Fiber Electromyography | Other | — | UNRESOLVED |
| Skin biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- MG subjects
- description
- MG subjects will have serum acetylcholine receptor (AChR) antibodies
- interventionNames
- Other: Skin biopsy
- Other: Single Fiber Electromyography
Primary outcomes (1)
- measure
- Immunoglobulin levels
- timeFrame
- 14 weeks
- description
- Immunoglobulin and IgG subtype levels, AChR autoantibody levels, IgG/autoantibody ratio will be listed, summarized and plotted graphically by visit.
Secondary outcomes (4)
- measure
- Lymphocyte subpopulations
- timeFrame
- 14 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.