Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis

UMIN ID: UMIN000001866

Registered date:10/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Dermatomyositis or polymyositis with interstitial pneumonia
• Date of first enrollment: 2009/04/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): (1)The patients are initially treated with methylprednisolone (m-PSL) pulse (1000 mg daily for three days) followed by oral prednisolone (1mg/kg daily). (2)Continuous intravenous CyA (2 mg/kg daily for initial dose) is started following m-PSL pulse therapy, and the dosage will be adjusted to a level of 200-300ng/ml.

Outcome(s)

• Primary Outcome: Clinical symptoms, Respiratory functional evaluation, Chest CT and X-ray, Blood examinations
• Secondary Outcome: To evaluate long-term prognosis To establish an effective therapeutic strategy

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: We exclude patients with active infectious disease, severe renal dysfunction and malignancy.

Related Information

• Primary Sponsor: Department of Neurology and Rheumatology, Shinshu University School of Medicine
• Source(s) of Monetary Support: Shinshu University School of Medicine