A Trial for Subjects With Systemic Lupus Erythematosus Wh... | NCT01305746 | Trialant

A Trial for Subjects With Systemic Lupus Erythematosus Wh... | NCT01305746 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A-623 high dose weekly	Experimental	High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study	Drug: A-623
A-623 low dose weekly	Experimental	Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study	Drug: A-623
A-623 high dose every 4 weeks	Experimental	High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study	Drug: A-623

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A-623	Drug	High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study	A-623 high dose weekly

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the long term safety of A-623 in subjects with SLE	Safety assessments such as AEs, SAEs, vital signs, ECG, clinical chemistry, hematology, and immunogenicity will be analyzed in a descriptive manner and will include infections, malignancies, injection site reactions and immunogenicity, neuropsychiatric events, and deaths	Until the drug is approved or the Sponsor discontinues the study

Contacts/Locations Module