|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00997412 |
|
Date of registration:
|
16/10/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis
Myfortic |
|
Scientific title:
|
Randomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis |
|
Date of first enrolment:
|
May 2009 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00997412 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Contacts
|
|
Name:
|
Jiann-Horng Yeh, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Shin Kong Wu Ho-Su Memorial Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Male or female age between 20-70 (including 20 and 70 years old).
- Osserman II and III Myasthenia Gravis.
- Positive serum anti-acetylcholine receptor antibodies.
- Poor control of disease with daily dose of prednisone = 30 mg or 0.5 mg/kg at 3
months before enrollment.
- Without immunosuppressive therapy other than steroid.
Exclusion Criteria:
- Ocular MG or minimal clinical syndrome that would not require the therapy of
steroids.
- Negative serum anti-acetylcholine receptor antibodies.
- Use immunosuppressants other than steroids in the preceding year.
- Previous use other investigational medication within 3 months or current participate
other clinical study.
- Poor renal function: serum creatinine > 3.0 mg/dl or estimated creatinine clearance <
30 ml/min
- Females who are pregnancy or breast-feeding.
- Recent history, within 5 years, of malignancy
- Unwilling or unable to participate the necessary continuous visits and examinations.
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Myasthenia Gravis
|
|
Intervention(s)
|
|
Drug: AZA
|
|
Drug: Mycophenolic acid
|
|
Primary Outcome(s)
|
|
The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission)
[Time Frame: One year after treatment]
|
|
Secondary Outcome(s)
|
|
Myasthenia gravis (MG) score
[Time Frame: One year after treatment]
|
|
Osserman clinical classification
[Time Frame: One year after treatment]
|
|
Secondary ID(s)
|
|
CERL080ATW07T
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|