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Monoclonal Antibodies

Intravenous Immunoglobulin for Muscular Dystrophy

Phase 2

Waitlist Available

Led By James Andrews, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

16 years of age or older

No moderate or severe respiratory or swallowing dysfunction due to Immune Mediated Necrotizing Myopathy at screening

Must not have

Oral glucocorticoid daily dose > 15mg at screening

> 1 oral conventional synthetic DMARD (e.g., methotrexate, mycophenolate mofetil, azathioprine) use at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 to 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the use of IVIG in treating a specific muscle disease. They will enroll 12 participants and randomly assign them to receive either IVIG or a placebo. The participants will receive the

Who is the study for?

This trial is for individuals with active anti-HMGCR immune-mediated necrotizing myopathy (IMNM), a muscle disease. Participants must meet specific health criteria to join and be willing to potentially receive a placebo. Those who have conditions that might interfere with the study or its results are not eligible.

What is being tested?

The MIGHT Trial is testing the effects of IVIG, an intravenous treatment made from pooled human immunoglobulin, on IMNM. Half of the participants will receive IVIG and half will get a saline solution as placebo, randomly assigned. The main outcomes will be measured at week 12.

What are the potential side effects?

IVIG can cause side effects such as headache, fever, chills, high blood pressure, fatigue, joint pain and allergic reactions. Since this is an exploratory trial, part of its purpose is to further understand these potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 16 years old or older.

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I do not have severe breathing or swallowing problems due to a specific muscle disease.

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I have tested positive for anti-HMGCR antibodies.

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I have never had a rash from dermatomyositis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take more than 15mg of oral glucocorticoids daily.

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I am currently taking a DMARD like methotrexate for my condition.

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I am currently taking statin medication.

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I am not pregnant, breastfeeding, and am willing to use effective birth control during the study.

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I have not had a heart attack, stroke, or severe chest pain in the last year.

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I have received IVIG for my muscle condition linked to HMGCR antibodies.

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I have not received Rituximab treatment in the last 6 months.

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I haven't had plasma exchange, cyclophosphamide, or biologic immunosuppressants in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 to 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 to 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage change in serum creatine kinase (CK)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intravenously Administered Pooled Human Immunoglobulin (IVIG)Experimental Treatment1 Intervention

Participants will receive intravenously administered pooled human immunoglobulin (IVIG) 2g/kg every 4 weeks for 24 weeks.

Group II: PlaceboActive Control1 Intervention

Participants will receive an infusion of 0.9% sodium chloride solution every 4 weeks for 24 weeks at equivalent volume to corresponding IVIG weight-based dose.

0 / 12Eligibility criteria met