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

This study is ongoing, but not recruiting participants.

First Received: March 29, 2006 Last Updated: February 17, 2009 History of Changes

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 anhydrous Tacrolimus

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 ]

Enrollment:	11
Study Start Date:	February 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 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

Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Astellas Pharma, Inc ( Director )
Study ID Numbers:	F506-CL-0602
Study First Received:	March 29, 2006
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00309101 History of Changes
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
Immunologic Factors
Neuromuscular Diseases
Tacrolimus

Myasthenia Gravis
Immunosuppressive Agents
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

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

Neuromuscular Junction Diseases
Tacrolimus
Myasthenia Gravis
Immunosuppressive Agents
Pharmacologic Actions
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 06, 2009