Overview

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

Status:
Unknown status

Trial end date:
2018-12-01

Target enrollment:
0

Participant gender:
All

Summary

This is a prospective open-label, uncontrolled, single-blind, pilot clinical trial. The primary objective is to assess the efficacy, safety, feasibility and tolerability of SCIG in patients with worsening MG. Participants with moderate worsening of MG symptoms (MGFA Class II and III) who are considered to be appropriate for immunoglobulin therapy will be screened for the study by the treating neurologist. Patients will be receive 2gm/kg (150gm for a 75kg patient) of 20% SCIG (Hizentra) infused over 4 weeks in a dose escalating manner. Additionally, this study will be assessing the feasibility of employing SCIG as an alternative therapy to IVIG in patients with MG exacerbation. The cost-effectiveness of SCIG versus IVIG will be evaluated, and the impact of SCIG therapy will be assessed from both a health-resource perspective and from a patient perspective.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Alberta

Collaborator:

CSL Behring

Treatments:

Antibodies
Immunoglobulin G
Immunoglobulins
Immunoglobulins, Intravenous

Criteria

Inclusion Criteria:

- Patients between18 to 80 years of age, diagnosed with MG (see below) who have
worsening myasthenic symptoms - (defined as increasing diplopia, ptosis, dysarthria,
dysphagia, difficulty chewing, or limb weakness severe enough to warrant
immunoglobulin therapy.

- MG diagnosis will be based upon the clinical evaluation by a neuromuscular expert and
meeting any two of the following supportive criteria:

1. Abnormal Tensilon test

2. Abnormal repetitive nerve stimulation studies

3. Abnormal single fiber electromyography (EMG)

4. Increased serum acetylcholine receptor or anti-MuSK antibodies

5. Prior response to immunotherapy

Exclusion Criteria:

1. Respiratory distress requiring ICU admission or a vital capacity <1 L

2. Severe swallowing difficulties with a high risk of aspiration

3. Change in corticosteroid dosage in the 4 weeks prior to screening

4. Known immunoglobulin A (IgA) deficiency

5. Pregnant or breast feeding women

6. Active renal or hepatic insufficiency, clinically significant cardiac disease

7. Patients with worsening weakness associated with an infectious process

8. Previous lack of responsiveness to IVIG

9. History of previous MG crises