Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia Gravis

March 24, 2015 updated by: University of Texas

OBJECTIVES:

I. Determine whether intravenous immunoglobulin is an effective therapy for patients with mild or moderate myasthenia gravis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PROTOCOL OUTLINE: This study is a randomized, blinded, controlled study. Patients are stratified in both groups according to prior thymectomy (yes vs no) and by Quantitative Myasthenia Gravis Score (equal to or less than 10 vs greater than 10) so that equal numbers are assigned to each group. Patients in group 2 are also stratified as to whether they are currently on azathioprine.

Patients are randomized to receive either intravenous immunoglobulin (IVIG) for 2 days or 5% albumin (the placebo) for 2 days. A second infusion of IVIG for 1 day or albumin placebo for 1 day is given on day 22.

At the end of 6 weeks, after the randomized study, patients may choose to receive 3 additional IVIG infusions.

Patients are followed on days 1, 21, 32, and 42 of randomized or open label study.

Completion date provided represents the completion date of the grant per OOPD records

Study Type

Interventional

Enrollment

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Mild or moderate generalized myasthenia gravis Grade 2 or 3 myasthenia gravis according to a modified Osserman groups system Ocular myasthenia gravis alone or myasthenia gravis in crisis not eligible Must have elevated acetylcholine receptor antibody titer No evidence of thymoma on chest CT or MRI No immunoglobulin-A deficiency less than 5 mg/dL Group 1: Patients who have not received other immunosuppressive therapy in the past, including intravenous immunoglobulin Group 2: Patients considered steroid-dependent

Considered steroid-dependent if demonstrated improvement following initiation of corticosteroid therapy but continue to have generalized weakness on examination despite receiving 20 mg of prednisone (or equivalent) every other day and experience unacceptable symptoms on lower doses Prednisone and other immunosuppressive drug doses must not have changed within last 4 weeks May have had other immunosuppressive medication (azathioprine, cyclosporine, cyclophosphamide) or have received plasma exchange if these treatments were not initiated in the 2 months prior to study enrollment Must be receiving immunosuppressive medication for at least 3 months prior to study

--Prior/Concurrent Therapy-- Endocrine therapy: Corticosteroid must be maintained at a constant dose during study Surgery: No thymectomy in the last 3 months Other: No plasmapheresis in the last 2 months --Patient Characteristics-- Age: 15 and over Weight: No greater than 80% above ideal body weight Hepatic: SGOT, SGPT, and alkaline phosphatase no greater than 1.5 times upper limit of normal (ULN) Renal: BUN no greater than ULN Creatinine no great than ULN Neurology: No history of relevant chronic degenerative, psychiatric, or neurologic disorder, other than myasthenia gravis, that can produce weakness or fatigue No altered consciousness, dementia, or abnormal mental status Pulmonary: Forced vital capacity at least 50% of predicted Not at high risk for aspiration Other: No active thyroid gland dysfunction as manifested by abnormal thyroid function tests or the need for current thyroid replacement Normal thyroid function tests required No other major relevant chronic or debilitating illnesses within 6 months of study Not pregnant or nursing Adequate contraception required of all fertile patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas

Investigators

  • Study Chair: Richard J. Barohn, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1995

Study Completion

March 1, 1999

Study Registration Dates

First Submitted

February 24, 2000

First Submitted That Met QC Criteria

February 24, 2000

First Posted (Estimate)

February 25, 2000

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/13250
  • UTSMC-FDR001362
  • UTSMC-039509700

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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