Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
Lead Sponsor:
Genentech, Inc.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely act...
Detailed Description
The study will be conducted in 3 parts. Parts 1 and 2 of the study will include a double-blind treatment period of 24 weeks and a safety follow-up period of 48 weeks for participants who do not contin...
Eligibility Criteria
Inclusion
- Diagnosis of SLE.
- Active disease at the time of screening.
- Agreement to use an effective form of contraception for the duration of the study.
Exclusion
- Acutely life- or organ-threatening manifestations of systemic lupus erythematosus (SLE) (eg, proliferative nephritis, unstable neuropsychiatric disease).
- Pregnancy or breastfeeding.
- History of severe allergic or anaphylactic reactions to monoclonal antibodies or intravenous (IV) immunoglobulin.
- Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude patient participation.
- Concomitant conditions that required systemic corticosteroid use within 1 year prior to screening. Use of topical, intraarticular, or inhaled corticosteroids is not exclusionary.
- History of cancer within 5 years of screening.
- Any current or recent (within 4 weeks of screening) signs or symptoms of infection, except for minor infections, fungal infections of the nail beds, or oral or vaginal candidiasis.
- History of severe systemic bacterial, fungal, viral, or parasitic infections (2 or more hospitalizations or 2 or more courses of IV antibiotics) within 6 months prior to screening
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00962832
Start Date
September 1 2009
End Date
August 1 2013
Last Update
August 12 2016
Active Locations (79)
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1
Anniston, Alabama, United States, 36207
2
Birmingham, Alabama, United States, 35294
3
Tucson, Arizona, United States, 85724
4
La Jolla, California, United States, 92037