What side effects are associated with this type of intervention?

Common treatments for Dermatomyositis, such as subcutaneous immunoglobulin (SCIG) and intravenous immunoglobulin (IVIG), are generally well-tolerated but can have side effects including infusion reactions, headache, fever, chills, and fatigue. Rituximab, another immunomodulatory treatment, can cause infusion reactions, infections, and hypogammaglobulinemia. Glucocorticoids, often used in combination therapies, may lead to weight gain, hypertension, diabetes, osteoporosis, and increased infection risk. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved intravenous immunoglobulin (IVIG) for the treatment of dermatomyositis, particularly in cases where patients have not responded to conventional treatments such as corticosteroids and immunosuppressants. IVIG works by modulating the immune response, similar to the subcutaneous immunoglobulin (IgPro20) being studied in the trial. Other immune-modulating therapies, such as rituximab, have also been used off-label for dermatomyositis, but they are not specifically FDA-approved for this condition.

What other types of research exist?

Promising alternatives to IgPro20 for Dermatomyositis patients include mycophenolate mofetil, rituximab, and high-dose intravenous immunoglobulins (IVIG). These treatments have shown efficacy in patients with refractory DM and are being explored for their potential benefits.

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Immunoglobulin

Human Immunoglobulin G for Dermatomyositis (RECLAIIM Trial)

Phase 3

Waitlist Available

Research Sponsored by CSL Behring

Eligibility Criteria Checklist

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

Must have

Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent

Disease severity defined by Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.

Must not have

Evidence of active malignant disease or malignancies diagnosed within the previous 5 years

Cancer-associated myositis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 17, 21, and 25

Awards & highlights

Pivotal Trial

Summary

This trial tests if injecting immunoglobulin proteins under the skin can help adults with dermatomyositis, a muscle disease, by boosting their immune system and reducing inflammation. Immunoglobulin has been used in dermatomyositis, showing improvements in muscle strength and skin rashes.

Who is the study for?

Adults over 18 with dermatomyositis can join this trial. They should be on a low dose of steroids and have moderate disease severity, confirmed by specific scales and muscle tests. People with recent cancer, significant past damage from the disease, or improvement before starting the study cannot participate.

What is being tested?

The trial is testing IgPro20, a human immunoglobulin G given under the skin against a placebo to see if it helps improve symptoms in adults with dermatomyositis. It's randomized and double-blind so neither doctors nor patients know who gets real treatment or placebo.

What are the potential side effects?

Possible side effects include reactions at the injection site like redness or pain, headaches, nausea, fatigue, fever, chills and potential increased risk of infections due to immune system effects.

Eligibility Criteria

Inclusion Criteria

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

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I take 20 mg or less of prednisolone or its equivalent daily.

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My doctor rates my disease as moderately severe or worse.

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I have been diagnosed with a type of muscle inflammation disease according to EULAR/ACR criteria.

Exclusion Criteria

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

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I have been diagnosed with cancer or had active cancer in the last 5 years.

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I have muscle inflammation related to my cancer.

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My doctor rates my condition as significantly damaged or improved recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 17, 21, and 25

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 17, 21, and 25

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 17, 21, and 25 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Responder Rate

Secondary study objectives

Mean TIS

Mean Total Improvement Score (TIS)

Mean change difference (IgPro20 minus placebo) in CDASI

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IgPro20Experimental Treatment1 Intervention

human immunoglobulin G administered subcutaneously

Group II: PlaceboPlacebo Group1 Intervention

human albumin solution administered subcutaneously

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Dermatomyositis (DM) include immunosuppressive agents like glucocorticoids, methotrexate, and mycophenolate mofetil, as well as immunomodulatory therapies such as intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) like IgPro20. These treatments primarily work by modulating the immune response to reduce inflammation and muscle damage. For instance, SCIG provides a steady supply of immunoglobulins that can neutralize autoantibodies and modulate immune cell activity, thereby decreasing the autoimmune attack on muscle tissues. This is crucial for DM patients as it helps in managing symptoms, improving muscle strength, and preventing disease progression.

Inflammatory myopathies: clinical, diagnostic and therapeutic aspects.