NCT01927692

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 16, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

August 20, 2013

Last Update Submit

July 15, 2015

Conditions

Myasthenia Gravis

Keywords

MG

Outcome Measures

Primary Outcomes (1)

  • Immunoglobulin levels

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

    14 weeks

Secondary Outcomes (4)

  • Lymphocyte subpopulations

    14 weeks

  • SFEMG

    14 weeks

  • Vaccination/protective antibodies

    14 weeks

  • Clinical Outcomes Assessments

    14 weeks

Study Arms (1)

MG subjects

MG subjects will have serum acetylcholine receptor (AChR) antibodies

Other: Skin biopsyOther: Single Fiber Electromyography

Interventions

Skin biopsyOTHER

An optional skin biopsy will be performed in up to 5 subjects at baseline and 2 weeks after therapeutic plasma exchange is completed.

MG subjects
Single Fiber ElectromyographyOTHER

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

Also known as: SFEMG
MG subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potentially eligible subjects with MG that will receive TPE as part of their clinical care will be identified from clinic encounters, emergency department visits, and hospitalizations.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jeffrey Guptill, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 23, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 16, 2015

Record last verified: 2015-06

Locations

US(2)