An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

This study is currently recruiting participants.

Verified by Astellas Pharma Inc, July 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00309101

Purpose

The purpose of the study is to investigate the efficacy and safety for steroid resistant, non-thymectomized MG patients.

Condition	Intervention	Phase
Myasthenia Gravis	Drug: tacrolimus	Phase III

MedlinePlus related topics: Myasthenia Gravis

Drug Information available for: Tacrolimus Tacrolimus anhydrous

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Improvement of clinical symptoms [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement of daily activity [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	February 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: tacrolimus Oral

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309101

Contacts

Contact: Clinical Development Administration, Astellas Pharma Inc.

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-0602
Study First Received:	March 29, 2006
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00309101
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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 16, 2009