Abstract

The primary objective of this trial is to determine doses of LJP 394 on the anti-dsDNA antibody concentration. The total duration of the trial is approximately 16 weeks (4 week screening period, 12 week dosing period). Parameters to be evaluated during the 16-week trial include: changes in anti-dsDNA antibody concentrations as measured by Farr and Elisa methodologies, changes in complement (C3,C4), results of the SLEDAI assessment of clinical studies and the MOS SF-36tm and changes in renal function parameters. The safety profile of LJP 394 will be assessed during the 16 week trial. Safety parameters will include: the incidence of adverse experiences and changes in the results of laboratory parameters (chemistry, hematology, coagulation and urinalysis), physical examinations, vital signs and SLEDAI assessments.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001070-24
Application #
6308106
Study Section
Project Start
1999-12-01
Project End
2000-11-30
Budget Start
Budget End
Support Year
24
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Medical University of South Carolina
Department
Type
DUNS #
183710748
City
Charleston
State
SC
Country
United States
Zip Code
29425

  Publications

Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 41:120-127
Putterman, Chaim; Pisetsky, David S; Petri, Michelle et al. (2018) The SLE-key test serological signature: new insights into the course of lupus. Rheumatology (Oxford) 57:1632-1640
Hall, Jordan T; Ebeling, Myla; Shary, Judy R et al. (2018) The relationship between physical activity and vitamin D status in postpartum lactating and formula-feeding women. J Steroid Biochem Mol Biol 177:261-265
Kelly, Clare B; Hookham, Michelle B; Yu, Jeremy Y et al. (2018) Response to Comment on Kelly et al. Subclinical First Trimester Renal Abnormalities Are Associated With Preeclampsia in Normoalbuminuric Women With Type 1 Diabetes. Diabetes Care 2018;41:120-127. Diabetes Care 41:e102-e103
Bell, Katherine A; Wagner, Carol L; Perng, Wei et al. (2018) Validity of Body Mass Index as a Measure of Adiposity in Infancy. J Pediatr 196:168-174.e1
Sen, Sarbattama; Penfield-Cyr, Annie; Hollis, Bruce W et al. (2017) Maternal Obesity, 25-Hydroxy Vitamin D Concentration, and Bone Density in Breastfeeding Dyads. J Pediatr 187:147-152.e1
Wolf, Bethany J; Spainhour, John C; Arthur, John M et al. (2016) Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol 68:1955-63
Wagner, C L; Baggerly, C; McDonnell, S et al. (2016) Post-hoc analysis of vitamin D status and reduced risk of preterm birth in two vitamin D pregnancy cohorts compared with South Carolina March of Dimes 2009-2011 rates. J Steroid Biochem Mol Biol 155:245-51
Hollis, Bruce W; Wagner, Carol L (2016) Response to commentary by D Roth. Evid Based Med 21:120
Hollis, Bruce W; Wagner, Carol L; Howard, Cynthia R et al. (2015) Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial. Pediatrics 136:625-34

Showing the most recent 10 out of 395 publications