A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis

A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy

To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.

Study Overview

• Status: Completed
• Conditions: Myasthenia Gravis
• Intervention / Treatment: Drug: Tacrolimus capsule; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Guangdong, China
  • Jiangsu, China
  • Jilin, China
  • Shandong, China
  • Shanghai, China
  • Sichuan, China
  • Wuhan, China
  • Zhejiang, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosed as myasthenia gravis (MG) by clinical diagnosis
• QMG scores ≥7 at the time of enrollment
• basic treatment drugs are mainly glucocorticoids, and the efficacy of glucocorticoid therapy was not sufficient

Exclusion Criteria:

• receiving blood purification therapy or immunoglobulin therapy within 8 weeks before the study
• QMG swallowing function score ≥ 2 points or QMG vital capacity = 3
• abnormal hepatic functions
• uncontrolled diabetes patients
• hyperkalemia patients
• immuno-inhibitors are forbidden due to malignancy, history of malignancy or history of HIV infection
• patients who are allergic to Tacrolimus or macrolide antibiotics
• receiving other immuno-inhibitors within 12 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tacrolimus group	Drug: Tacrolimus capsule; oral; Other Names: Prograf; FK506
Placebo Comparator: placebo group	Drug: Placebo; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity	Baseline and at 24 weeks
Change from baseline in QMG score for disease severity	Baseline and at 4 weeks
Change from baseline in QMG score for disease severity	Baseline and at 8 weeks
Change from baseline in QMG score for disease severity	Baseline and at 12 weeks
Change from baseline in QMG score for disease severity	Baseline and at 16 weeks
Change from baseline in QMG score for disease severity	Baseline and at 20 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Osserman classification	Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Changes in myasthenia gravis activity of daily living scale	Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma China, Inc.

Publications and helpful links

General Publications

• Zhou L, Liu W, Li W, Li H, Zhang X, Shang H, Zhang X, Bu B, Deng H, Fang Q, Li J, Zhang H, Song Z, Ou C, Yan C, Liu T, Zhou H, Bao J, Lu J, Shi H, Zhao C. Tacrolimus in the treatment of myasthenia gravis in patients with an inadequate response to glucocorticoid therapy: randomized, double-blind, placebo-controlled study conducted in China. Ther Adv Neurol Disord. 2017 Sep;10(9):315-325. doi: 10.1177/1756285617721092. Epub 2017 Jul 26.

Helpful Links

• Link to Results on JAPIC - enter 150713 in the JapicCTI-RNo. field
• Link to results on Astellas Clinical Study Results Web site

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): March 9, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: prograf; immunosuppressant
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Neoplasms by Site; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Muscle Weakness; Myasthenia Gravis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: F506-CL-0611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No