NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Systemic Lupus Erythematosus
Date of first enrollment	11/05/2012
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : MEDI-546 INN of investigational material : Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational material : Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks Generic name etc : MEDI-546 INN of investigational material : Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational material : Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks Generic name etc : MEDI-546 INN of investigational material : Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational material : Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 65age old
Gender	Both
Include criteria	- Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE. - Weight greater than or equal to 40.0 kg. - Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for 24 weeks or more prior to screening. - Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives. - Active moderate to severe SLE disease based on SLE disease activity score.
Exclude criteria	- Active severe or unstable neuropsychiatric SLE. - Active severe SLE-driven renal disease or unstable renal disease. - Clinically significant active infection including ongoing and chronic infections. - Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection. - Confirmed positive tests for hepatitis B or positive test for hepatitis C.