Myasthenia GravisPhase 3NCT01325571
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis
A Phase 3 study testing Tacrolimus capsule in people with Myasthenia Gravis, run by Astellas Pharma Inc at 9 sites in China.
Trial summary
To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Tacrolimus capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 9 sitesChina
- Study dates
- Mar 2011to May 2014
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Study site
Beijing
Study site
Guangdong
Study site
Jiangsu
Study site
Jilin City
Study site
Shandong
Study site
Shanghai
Study site
Sichuan
Study site
Wuhan
Study site
Zhejiang
About this study
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
To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.
- Conditions
- Myasthenia Gravis
- Being tested
- Tacrolimus capsule, Placebo
- Keywords
- prograf, immunosuppressant
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus capsuleDrug
Also called Prograf, FK506
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| tacrolimus group | Experimental | Not described Receives: Drug: Tacrolimus capsule |
| placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity
Measured: Baseline and at 24 weeks
Change from baseline in QMG score for disease severity
Measured: Baseline and at 4 weeks
Change from baseline in QMG score for disease severity
Measured: Baseline and at 8 weeks
Change from baseline in QMG score for disease severity
Measured: Baseline and at 12 weeks
Change from baseline in QMG score for disease severity
Measured: Baseline and at 16 weeks
Change from baseline in QMG score for disease severity
Measured: Baseline and at 20 weeks
Secondary outcomes (2)
Changes in Osserman classification
Measured: 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
Measured: Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma China, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325571
- Sponsor's protocol ID
- F506-CL-0611
- Status last verified
- Mar 2016
- First submitted
- 16 Mar 2011
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 28861121
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01325571
- Acronym / sponsor ID
- F506-CL-0611
- Conditions
- Myasthenia Gravis
- Keywords
- prograf, immunosuppressant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma China, Inc.
- Study start
- Mar 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Mar 2011 (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.
To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tacrolimus group | Experimental | Drug: Tacrolimus capsule |
| placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Tacrolimus capsuleAlso: Prograf, FK506oral | Drug | tacrolimus group |
| Placebooral | Drug | placebo group |
Primary outcome
Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity
Time frame: Baseline and at 24 weeks
Change from baseline in QMG score for disease severity
Time frame: Baseline and at 4 weeks
Change from baseline in QMG score for disease severity
Time frame: Baseline and at 8 weeks
Change from baseline in QMG score for disease severity
Time frame: Baseline and at 12 weeks
Change from baseline in QMG score for disease severity
Time frame: Baseline and at 16 weeks
Change from baseline in QMG score for disease severity
Time frame: Baseline and at 20 weeks
2 secondary outcomes
Changes in Osserman classification
Time frame: 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
Time frame: Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Derived from this study: PubMed 28861121Zhou 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.
- Individual participant dataSharing planned: Undecided
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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.
Use Central Contact study chair
Astellas Pharma Inc
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus capsule in people with Myasthenia Gravis, run by Astellas Pharma Inc at 9 sites in China.
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 3 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: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity (time frame: Baseline and at 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01325571, which also lists 1 linked publication.
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 9 Mar 2016.