A Study of LY2127399 in Patients With Systemic Lupus Erythematosus
|ClinicalTrials.gov Identifier: NCT01196091|
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : February 2, 2016
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
Results Submitted - Not Posted on ClinicalTrials.gov
Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
|Recruitment Status :||Completed|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||June 2015|
|Certification/Extension First Submitted :||September 29, 2014|
|Submission Cycle||Results Submitted to ClinicalTrials.gov||Results Returned after Quality Control Review|
March 24, 2018
||April 25, 2018|
May 11, 2018|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Kalunian KC, Urowitz MB, Isenberg D, Merrill JT, Petri M, Furie RA, Morgan-Cox MA, Taha R, Watts S, Silk M, Linnik MD. Clinical trial parameters that influence outcomes in lupus trials that use the systemic lupus erythematosus responder index. Rheumatology (Oxford). 2018 Jan 1;57(1):125-133. doi: 10.1093/rheumatology/kex368.
Rovin BH, Dooley MA, Radhakrishnan J, Ginzler EM, Forrester TD, Anderson PW. The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials. Lupus. 2016 Dec;25(14):1597-1601. Epub 2016 May 24.
Hoffman RW, Merrill JT, Alarcón-Riquelme MM, Petri M, Dow ER, Nantz E, Nisenbaum LK, Schroeder KM, Komocsar WJ, Perumal NB, Linnik MD, Airey DC, Liu Y, Rocha GV, Higgs RE. Gene Expression and Pharmacodynamic Changes in 1,760 Systemic Lupus Erythematosus Patients From Two Phase III Trials of BAFF Blockade With Tabalumab. Arthritis Rheumatol. 2017 Mar;69(3):643-654. doi: 10.1002/art.39950.
Isenberg DA, Petri M, Kalunian K, Tanaka Y, Urowitz MB, Hoffman RW, Morgan-Cox M, Iikuni N, Silk M, Wallace DJ. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):323-31. doi: 10.1136/annrheumdis-2015-207653. Epub 2015 Sep 3.