FK506 Phase 3 Study: a Study for Steroid Non-Resistant Myasthenia Gravis (MG) Patients - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00309088

Purpose

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.

Condition	Intervention	Phase
Myasthenia Gravis	Drug: tacrolimus Drug: placebo	Phase III

MedlinePlus related topics: Myasthenia Gravis

Drug Information available for: Tacrolimus Tacrolimus anhydrous

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.] [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total amount of steroid therapy (mg) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
QMG score;MG-ADL [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Success rate of achievement to the targeted steroid dose [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	April 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: tacrolimus oral
2: Placebo Comparator	Drug: placebo oral

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309088

Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma, Inc. ( Director )
Study ID Numbers:	F506-CL-0601
Study First Received:	March 29, 2006
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00309088
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

Tacrolimus
Myasthenia Gravis

Study placed in the following topic categories:

Autoimmune Diseases
Neuromuscular Diseases
Myasthenia gravis

Tacrolimus
Myasthenia Gravis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases

Neuromuscular Junction Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009