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Immunoglobulin Therapy

Human normal immunoglobulin G (IgG) for Myasthenia Gravis (SCIG-MG Trial)

Phase 3

Waitlist Available

Led By Zaeem A Siddiqi, MD, PhD

Research Sponsored by University of Alberta

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 day 42

Awards & highlights

SCIG-MG Trial Summary

This trial is open-label, uncontrolled, single-blind, and pilot, meaning that the primary objective is to assess the efficacy, safety, feasibility and tolerability of SCIG in patients with worsening MG. The study will also be assessing the feasibility of employing SCIG as an alternative therapy to IVIG in patients with MG exacerbation from different perspectives including cost-effectiveness.

SCIG-MG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 42

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 42

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 42 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to day 42 after treatment.

Secondary outcome measures

Adverse events related to SCIG infusions will be recorded if/when they occur.

Change in Manual Muscle Testing (MMT) score from baseline to day 42 after treatment.

Myasthenia Gravis (MG) Composite scores will be used to evaluate disease severity through a number of functional assessments, including muscle strength and ability to complete activities of daily living.

+5 more

Other outcome measures

Change in QOL 36 score from Baseline to day 42)

Cost effectiveness of SCIG therapy will be calculated in comparison to standard IVIG therapy. This will indicate health economics.

Infusion nurse's assessment of this participant population's ability to use this treatment modality (Written impression)

+7 more

SCIG-MG Trial Design

1Treatment groups

Experimental Treatment

Group I: SC Treatment PeriodExperimental Treatment1 Intervention

Participants will receive 2gm/kg of Human normal immunoglobulin G (IgG) infused over 4 weeks in a dose escalating manner as follows: 1st week: 2-3 SCIG infusions of 10ml per site at four sites (total dose 16 to 24g)* 2nd week: 2-3 SCIG infusions of 15ml per site at four sites (total dose 24 to 36g)* 3rd week: 2-4 SCIG infusions of 20ml per site at four sites (total dose 32 to 64g)* 4th week: 2-4 SCIG infusions of 25ml per site at four sites (total dose 40 to 80g)* Doses indicated are study recommended. Doses may be adjusted depending on tolerance and total dose required by the patient.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Human normal immunoglobulin G (IgG)

2014

Completed Phase 3

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,932 Total Patients Enrolled

CSL BehringIndustry Sponsor

194 Previous Clinical Trials

1,211,196 Total Patients Enrolled

2 Trials studying Myasthenia Gravis

27 Patients Enrolled for Myasthenia Gravis

Zaeem A Siddiqi, MD, PhDPrincipal InvestigatorUniversity of Alberta

1 Previous Clinical Trials

3 Total Patients Enrolled

Frequently Asked Questions

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

Does this research allow octogenarians to enroll?

"This particular trial is designed for patients aged 18 to 80. However, if you are not within that age range, there might still be other trials enrolling that would be a better fit - 26 clinical trials are currently underway for people under the age of 18 and 53 for those over 65."

Answered by AI

Might I be a right fit to take part in this clinical trial?

"The requirements for patients hoping to join this study are as follows: myasthenia gravis and between 18-80 years old. So far, 30 people have been enrolled in the trial."

Answered by AI

Is it okay for patients to use Human normal immunoglobulin G (IgG)?

"Phase 3 trials have some data supporting efficacy and multiple rounds of safety data, so our team has given it a score of 3."

Answered by AI

What are the most common conditions that Human normal immunoglobulin G (IgG) can help alleviate?

"Human normal immunoglobulin G (IgG) is a protein that can be used to treat bruton's agammaglobulinemia, a condition characterized by the absence of gamma globulin in the blood. IgG can also be used to manage primary immunodeficiencies (PID), agammaglobulinemia, and chronic inflammatory demyelinating polyradiculoneuropathy."

Answered by AI

Is Human normal immunoglobulin G (IgG) a new area of research?

"Human normal immunoglobulin G (IgG) was originally studied in the year 2008 at Montefiore Medical Center. Since then there have been 166 completed studies, 37 of which are ongoing. Many of these trials are taking place out of Edmonton, Alberta."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)

Zaeem Siddiqi 2014. "A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02774239.