A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.
- Conditions
- Myasthenia GravisMedDRA version: 20.0 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-005099-17-DE
- Lead Sponsor
- Grifols Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
1. Male or female ages 18 to 85 years
2. Anti-AChR antibody positive
3. Confirmed diagnosis of generalized MG historically meeting the clinical criteria for diagnosis of MG defined by the MGFA classification of Class II, III, IV, or V historically (Appendix 2).
4. At Screening, subjects may have symptoms controlled by CS (for example, only ocular [Class I] symptoms may be evident or there may be no symptoms) or be MGFA Class II-IVa inclusive (Class IVb and Class V excluded). Note: Subjects who only have a history of ocular MG may not enroll.
5. On systemic CS for a minimum period of at least three months and on a stable CS dose of =15 mg/day and =60 mg/day (prednisone equivalent) for the month prior to Screening. Individuals on alternate day CS dosing will be judged to be on a daily dose equivalent to half their alternate day dose (i.e., 40 mg/every other day = 20 mg/day).
6. The investigator feels that tapering the CS dose is currently appropriate (to be commenced as prescribed during this protocol)
7. At least one previous completed attempt to taper CS in order to minimize CS dose
8. Subjects must be willing and able to provide written informed consent.
9. Subjects must be willing to comply with all aspects of the clinical trial protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1. Any dose change in concomitant immunosuppressant therapy, other than CS, in the prior six months
2. Any change in CS dose or acetylcholinesterase inhibitor (e.g., pyridostigmine) dose in the one month prior to Screening
3. A three-point change in QMG score, increased or decreased, between the Screening/Week -3 (Visit 0) and Baseline (Week 0 [Visit 1])
4. Any episode of MC in the one month prior to Screening or (at any time in the past) MC or hospitalization for MG exacerbation associated with a previous CS taper attempt
5. Evidence of malignancy within the past 5 years (non-melanoma skin
cancer, carcinoma in situ of cervix is allowed) or thymoma potentially requiring surgical intervention during the course of the trial (intent to
perform thymectomy)
6. Thymectomy within the preceding six months prior to Screening
7. Rituximab, belimumab, eculizumab or any monoclonal antibody used for
immunomodulation within the past 12 months prior to Screening
8. History of non-response to IVIg when used in maintenance therapy of the subject’s MG, as judged by the investigator
9. Have received immune globulin treatment given by IV, subcutaneous, or intramuscular route within the last 3 months prior to Screening
10. Received plasma exchange (PLEX) performed within the last 3 months prior to Screening
11. Inadequate venous access
12. History of anaphylactic reactions or severe reactions to any blood-derived product
13. History of intolerance to any component of the IPs
14. Documented diagnosis of thrombotic complications to polyclonal IVIg therapy in the past
15. History of recent (within the last year) myocardial infarction or stroke
16. Uncontrolled congestive heart failure; embolism; or historically documented (within the last year) electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial fibrillation
17. Current known hyperviscosity or hypercoagulable state
18. Currently receiving anti-coagulation therapy (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], parenteral anticoagulants [e.g., fondaparinux]). Note that oral anti-platelet agents are allowed (e.g., aspirin, clopidogrel, ticlodipine)
19. History of chronic alcoholism or illicit drug abuse (addiction) in the 12 months preceding the Screening/Week -3 (Visit 0)
20. Active psychiatric illness that interferes with compliance or communication with health care personnel
21. Females of child-bearing potential who are pregnant, have a positive serum pregnancy test (human chorionic gonadotropin [HCG]-based assay), breastfeeding, or are unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/ gel/film/cream/suppository, male sterilization, or true abstinence*) throughout the study.
* True abstinence: When this is in line with the preferred and usual lifestyle of th
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method