search
Back to results

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

Primary Purpose

Myasthenia Gravis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tacrolimus capsule
Placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myasthenia Gravis focused on measuring prograf, immunosuppressant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tacrolimus group

placebo group

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity
Change from baseline in QMG score for disease severity
Change from baseline in QMG score for disease severity
Change from baseline in QMG score for disease severity
Change from baseline in QMG score for disease severity
Change from baseline in QMG score for disease severity

Secondary Outcome Measures

Changes in Osserman classification
Changes in myasthenia gravis activity of daily living scale

Full Information

First Posted
March 16, 2011
Last Updated
March 8, 2016
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma China, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01325571
Brief Title
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma China, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis
Keywords
prograf, immunosuppressant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tacrolimus group
Arm Type
Experimental
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tacrolimus capsule
Other Intervention Name(s)
Prograf, FK506
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity
Time Frame
Baseline and at 24 weeks
Title
Change from baseline in QMG score for disease severity
Time Frame
Baseline and at 4 weeks
Title
Change from baseline in QMG score for disease severity
Time Frame
Baseline and at 8 weeks
Title
Change from baseline in QMG score for disease severity
Time Frame
Baseline and at 12 weeks
Title
Change from baseline in QMG score for disease severity
Time Frame
Baseline and at 16 weeks
Title
Change from baseline in QMG score for disease severity
Time Frame
Baseline and at 20 weeks
Secondary Outcome Measure Information:
Title
Changes in Osserman classification
Time Frame
Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Title
Changes in myasthenia gravis activity of daily living scale
Time Frame
Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Beijing
Country
China
City
Guangdong
Country
China
City
Jiangsu
Country
China
City
Jilin
Country
China
City
Shandong
Country
China
City
Shanghai
Country
China
City
Sichuan
Country
China
City
Wuhan
Country
China
City
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28861121
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 150713 in the JapicCTI-RNo. field
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=F506-CL-0611
Description
Link to results on Astellas Clinical Study Results Web site

Learn more about this trial

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

We'll reach out to this number within 24 hrs