Myasthenia GravisMyforticNCT00997412
Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis
A study testing Mycophenolic acid and AZA in people with Myasthenia Gravis, run by Qualitix Clinical Research Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Mycophenolic acid and AZA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Randomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis
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.
Read the 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.
- Conditions
- Myasthenia Gravis
- Being tested
- Mycophenolic acid, AZA
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolic acidDrug
180 mg/tablet, 4 tablets twice daily
AZADrug
1 tablet AZA (50 mg/tab) and 4 tablets MA placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| MA | Experimental | MA group: 1 tablet AZA placebo and 4 tablets MA (180mg/tab,720 mg/day) twice daily Receives: Drug: Mycophenolic acid |
| AZA | Active comparator | AZA group: 1 tablet AZA (50mg/tab) and 4 tablets MA placebo twice daily Receives: Drug: AZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission)
Measured: One year after treatment
Secondary outcomes (2)
Osserman clinical classification
Measured: One year after treatment
Myasthenia gravis (MG) score
Measured: One year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qualitix Clinical Research Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jiann-Horng Yeh, M.D., Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997412
- Sponsor's protocol ID
- CERL080ATW07T
- Acronym
- Myfortic
- Status last verified
- Oct 2009
- First submitted
- 16 Oct 2009
- Last updated
- 19 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT00997412
- Acronym / sponsor ID
- Myfortic / CERL080ATW07T
- Conditions
- Myasthenia Gravis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qualitix Clinical Research Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MA | Experimental | Drug: Mycophenolic acidMA group: 1 tablet AZA placebo and 4 tablets MA (180mg/tab,720 mg/day) twice daily |
| AZA | Active comparator | Drug: AZAAZA group: 1 tablet AZA (50mg/tab) and 4 tablets MA placebo twice daily |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolic acid180 mg/tablet, 4 tablets twice daily | Drug | MA |
| AZA1 tablet AZA (50 mg/tab) and 4 tablets MA placebo twice daily | Drug | AZA |
Primary outcome
The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission)
Time frame: One year after treatment
2 secondary outcomes
Osserman clinical classification
Time frame: One year after treatment
Myasthenia gravis (MG) score
Time frame: One year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiann-Horng Yeh, M.D. principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Mycophenolic acid and AZA in people with Myasthenia Gravis, run by Qualitix Clinical Research Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission) (time frame: One year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2009.