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Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC) — LUPSENIC  

Systemic Lupus Clinical Trial

Official title:
Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE)

Clinical Trial Summary

Primary objectives :

- To investigate the safety and the tolerability of ATO by IV infusions to patients with SLE,

- To determine the maximum tolerated dose of ATO.

Secondary objectives :

- Evaluation of the clinical and biological response of the SLE to ATO,

- Time of relapse in case of positive response,

- Determination of the efficacy,

- Pharmacokinetic study of ATO.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01738360
Study type Interventional
Source Nantes University Hospital
Contact
Status Terminated
Phase Phase 2
Start date July 2013
Completion date October 2015
View Details
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