Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - None

akashima Yasuharu0 sites150 target enrollmentMarch 15, 2019

Overview

No summary available.

Registry

who.int

Start Date

March 15, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

akashima Yasuharu

•(1\) Objectives must have been classified as systemic lupus erythematosus (SLE) based on the classification criteria of the American College of Rheumatology.
•(2\) Objectives need a systemic corticosteroid treatment of a dose of equal to or more than 0\.5mg/kg/day (converted to prednisolone dose) for SLE.
•(3\) Objectives are hospitalized.
•(4\) Objectives are the age of 20 or more.
•(5\) Objectives have consented to participate in the study after fully informed.
•(6\) Objectives that the laboratory data meets all the following.
•i) Patients with more than 70,000/microL of platelets.
•ii) Patients with less than 100IU/L of AST or ALT.
•iii) Patients with more than 50ml/min of creatinine clearance.

•(1\) Objectives have never had corticosteroid treatment before the entry to the trial.
•(2\) Objectives have never been affected with osteonecrosis of the femoral head.
•(3\) Patients with any active bleeding lesion.
•(4\) Patients with any active infection.
•(5\) Patients have any contraindication to candidate drugs for prevention.
•(6\) Patients have any past histories of anaphylaxis to test drugs for prevention.
•(7\) Female in pregnancy, lactation period, having a possibility of pregnancy.
•(8\) Patients taking below contraindicative drugs.
•1\. antiplatelet drugs expect clopidogrel
•2\. anticoagulant