Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Immunology | Musculoskeletal | Rheumatology | Family Medicine
Disease Category: Lupus
Location: United States, GA

Clinical Trial Details

Overview

Research Study Summary

A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Investigational Product in Patients With Systemic Lupus Erythematosus (SLE)

Purpose

A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Investigational Product in Patients With Systemic Lupus Erythematosus (SLE)

Patient Inclusion Criteria:

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
  • Have positive antinuclear antibodies (ANA)
  • Agree not to become pregnant throughout the course of the trial
  • Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)score at screening

Patient Exclusion Criteria

  • Have active severe Lupus kidney disease
  • Have active Central Nervous System or peripheral neurologic disease
  • Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
  • Have active or recent infection within 30 days of screening
  • Have had a serious infection within 90 days of randomization
  • Have evidence or test positive for Hepatitis B
  • Have Hepatitis C
  • Are human immunodeficiency virus (HIV) positive
  • Have evidence of active or latent tuberculosis (TB)
  • Presence of significant laboratory abnormalities at screening
  • Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
  • Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
  • Have changed your dose of antimalarial drug in the past 30 days
  • Have changed your dose of immunosuppressive drug in the past 90 days
  • Have previously received rituximab

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Suzi DeFiesta, Research Administrator
CSI Research Inc
11379 Southbridge Parkway Suite B
Alpharetta, GA 30022
Phone: 770-667-0220
Fax: 770-667-0227

View Map

Research Center Information: CSI Research Inc

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

Name:
Address:
City:
State:
Zip/Postal Code:
Country:
Phone:
Email:  
Message:
 
Please leave this field empty.

CW ID: 175421

Date Last Changed: July 22, 2013


DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.