Trial record 13 of 34 for:
Myasthenia Gravis
Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis (Myfortic)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Qualitix Clinical Research Co., Ltd..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Qualitix Clinical Research Co., Ltd.
Information provided by:
Qualitix Clinical Research Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00997412
First received: October 16, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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Purpose
This is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive drugs, in myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis (MG) patients who are poor controlled under prior steroid therapy. All subjects should be randomly assigned to MA group and AZA group that will receive routine pyridostigmine and prednisolone in combination with MA or AZA.
| Condition | Intervention |
|---|---|
|
Myasthenia Gravis |
Drug: Mycophenolic acid Drug: AZA |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis |
Resource links provided by NLM:
Genetics Home Reference related topics:
myasthenia gravis
Drug Information available for:
Azathioprine
Mycophenolic acid
Mycophenolate sodium
Azathioprine Sodium
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by Qualitix Clinical Research Co., Ltd.:
Primary Outcome Measures:
- The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission) [ Time Frame: One year after treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Osserman clinical classification [ Time Frame: One year after treatment ] [ Designated as safety issue: Yes ]
- Myasthenia gravis (MG) score [ Time Frame: One year after treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MA
MA group: 1 tablet AZA placebo and 4 tablets MA (180mg/tab,720 mg/day) twice daily
|
Drug: Mycophenolic acid
180 mg/tablet, 4 tablets twice daily
|
|
Active Comparator: AZA
AZA group: 1 tablet AZA (50mg/tab) and 4 tablets MA placebo twice daily
|
Drug: AZA
1 tablet AZA (50 mg/tab) and 4 tablets MA placebo twice daily
|
Detailed Description:
This will be a double-dummy study to keep the blinded quality.
- MA group: 1 tablet AZA placebo and 4 tables MA (180 mg/tab,720 mg/day) twice daily.
AZA group: 1 tablet AZA (50mg/tab) and 4 tables MA placebo twice daily.
- When patients achieve minimal manifestation (MM, i.e. complete remission), which lead to normal daily routine, the dose of pyridostigmine should reduce to 240 mg/day (4 tablets) or less. The dose of steroid should be stepped down by 10 mg qod (every other day) for every 2 weeks until the dose achieves 40 mg qod. After that, the dose should be stepped down by 5 mg qod for every month.
- When disease progresses and is no longer maintaining minimal manifestation, the dose of steroid will be stepped up by 10 mg qod for every 2 weeks until achieve clinical stable remission. The taper rule of steroid could start again 1 month after stabilization.
- Every patient will be treated for 1 year. If the patient could not achieve MM within 1 year, the blind of individual patient will be opened and the patients will be crossed over to another medical treatment. The efficacy and safety of second medication will be observed openly until the end of study.
- When the muscle weakness worsens under established study schedule, plasmapheresis could be conducted to improve the condition rapidly.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jiann-Horng Yeh / M.D., Shin Kong Wu Ho-Su Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00997412 History of Changes |
| Other Study ID Numbers: | CERL080ATW07T |
| Study First Received: | October 16, 2009 |
| Last Updated: | October 16, 2009 |
| Health Authority: | Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Myasthenia Gravis Muscle Weakness Autoimmune Diseases of the Nervous System Nervous System Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Pathologic Processes Signs and Symptoms Azathioprine |
Mycophenolate mofetil Mycophenolic Acid Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antibiotics, Antineoplastic Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013