Clinical trial · Interventional
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis
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
NCT01325571CI-TRIAL-00021277completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Tacrolimus capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- tacrolimus group
- interventionNames
- Drug: Tacrolimus capsule
- type
- PLACEBO_COMPARATOR
- label
- placebo group
- interventionNames
- Drug: Placebo
Primary outcomes (6)
- measure
- Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity
- timeFrame
- Baseline and at 24 weeks
- measure
- Change from baseline in QMG score for disease severity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhou 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. PMID 28861121