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Immunoglobulin

Subcutaneous Immunoglobulin for Myasthenia Gravis (MG_SCIG Trial)

Phase 2

Recruiting

Led By Hans Katzberg, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

MG_SCIG Trial Summary

This trialwill examine the safety and effectiveness of a new subcutaneous immunoglobulin for treating myasthenia gravis and compare it to existing IVIG treatments.

Who is the study for?

Adults over 18 with moderate to severe Myasthenia Gravis (MG) can join this trial. They should be classified as MGFA Class II-IV and have a confirmed diagnosis of MG. Participants must be able to consent and complete study procedures but cannot join if pregnant, breastfeeding, or have had certain treatments like thymectomy or biologic agents recently.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of Cuvitru 20% SCIG for treating MG. It compares two groups: one receiving IVIG followed by SCIG, and the other getting only SCIG. The goal is also to see which treatment patients prefer and how they affect quality of life.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, headache, nausea, fatigue, allergic reactions including anaphylaxis, muscle pain, fever or chills. There may also be risks related to kidney function or liver enzymes.

MG_SCIG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Myasthenia Gravis Impairment Index Efficacy Outcome

Secondary outcome measures

Myasthenia Gravis Activities of Daily Living Efficacy Outcome

Myasthenia Gravis Composite Efficacy Outcome

Myasthenia gravis Quality of Life 15 Score Efficacy Outcome

+3 more

MG_SCIG Trial Design

2Treatment groups

Active Control

Group I: IVIG + SCIGActive Control1 Intervention

This group of MG patients will start with 2g/kg of IVIG on month 1, 1 g/kg of IVIG 4 and then 8 weeks later, and within 2 weeks switch to SCIG treatment

Group II: SCIG aloneActive Control1 Intervention

This group of MG patients will start with SCIG alone

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,460 Total Patients Enrolled

2 Trials studying Myasthenia Gravis

137 Patients Enrolled for Myasthenia Gravis

Hans Katzberg, MDPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

Intravenous Immunoglobulin + Subcutaneous Immunoglobulin (Immunoglobulin) Clinical Trial Eligibility Overview. Trial Name: NCT04728425 — Phase 2

Myasthenia Gravis Research Study Groups: IVIG + SCIG, SCIG alone

Myasthenia Gravis Clinical Trial 2023: Intravenous Immunoglobulin + Subcutaneous Immunoglobulin Highlights & Side Effects. Trial Name: NCT04728425 — Phase 2

Intravenous Immunoglobulin + Subcutaneous Immunoglobulin (Immunoglobulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04728425 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions generally benefit from the use of SCIG alone?

"Bruton's Agammaglobulinemia is commonly treated through the use of Subcutaneous Immunoglobulin alone (SCIG). SCIG has also been demonstrated to be beneficial in treating Primary Immunodeficiencies (PID), Agammaglobulinemia, and Chronic Inflammatory Demyelinating Polyradiculoneuropathy."

Answered by AI

Has the Food and Drug Administration sanctioned self-administered subcutaneous immunoglobulin (SCIG) as a treatment?

"Data on SCIG safety is limited, so it was assigned a score of 2. As this is Phase 2 clinical trial, there exists evidence that the drug can be administered without significant adverse events but there are no studies supporting its efficacy yet."

Answered by AI

How many individuals have enrolled in this trial?

"Affirmative. According to clinicaltrials.gov, this healthcare trial is actively recruiting for participants and was first announced on August 28th 2020 with a last update of November 21st 2022. 30 volunteers need to be found from 1 medical centre."

Answered by AI

Are seniors eligible to partake in this experiment?

"To be eligible for this medical trial, patients must fall between the ages of 18 and 100. Additionally, there are 30 clinical trials exclusively for minors and 89 studies available to individuals older than 65 years old."

Answered by AI

Is enrollment for this investigation still open?

"This medical study, which was publicly announced on August 28th 2020 is currently in need of participants. The information regarding the trial has been kept up to date and its most recent revision occurred on November 21st 2022."

Answered by AI

How can I enroll in this experiment?

"This research initiative seeks 30 patients aged 18-100 with muscular debilitation. The most pertinent requirements for applicants are: their willingness to participate and provide consent, being over the legal age of maturity, having a quantitative myasthenia gravis score above 10 or an impairment index evaluation that yields a value higher than 11."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Subcutaneous Immunoglobulin for Myasthenia Gravis

Hans Katzberg 2020. "Subcutaneous Immunoglobulin for Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04728425.

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