FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients

Astellas

Status and phase: Completed; Phase 3

Conditions: Myasthenia Gravis

Treatments: Drug: tacrolimus; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00309088

F506-CL-0601

Details and patient eligibility

About

The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.

Enrollment: 80 patients

Sex: All

Ages: 16 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically diagnosed as myasthenia gravis
• Those whose MG symptoms are well-controlled by the treatment with prednisone
• Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain

Exclusion criteria

• Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
• Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug
• Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.
• Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.
• Pancreatitis or diabetes
• Serum creatinine≦1.5mg/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: tacrolimus

2

Placebo Comparator group

Treatment:

Drug: placebo