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Completed

NCT Number: NCT00309088

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

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.

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Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

16 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu Region, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

oral

Other names: Prograf, FK506

Placebo

Drug

oral

Primary outcomes

  1. 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

Secondary outcomes

  1. Total amount of steroid therapy (mg)

    Time frame: 6 Months

  2. QMG score;MG-ADL

    Time frame: 6 Months

  3. Success rate of achievement to the targeted steroid dose

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 31, 2006
Registry last updated
Aug 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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