Clinical Trial: Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study)
Brief Summary: The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy of MT-1303 in subjects with systemic lupus erythematosus
Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation
Current Primary Outcome: Number of Subjects with Adverse Events [ Time Frame: up to 36 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from Baseline in anti-dsDNA and complement [ Time Frame: baseline and 24 weeks ]
- Change from Baseline in Lymphocyte counts [ Time Frame: baseline and 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Mitsubishi Tanabe Pharma Corporation
Dates:
Date Received: November 18, 2014
Date Started: February 2015
Date Completion: June 2017
Last Updated: January 27, 2017
Last Verified: January 2017
