[HTML][HTML] The role of master protocols in pediatric drug development

RM Nelson, LS Conklin, WJ Komocsar, F Chen… - … Innovation & Regulatory …, 2022 - Springer
Master protocols are innovative clinical trial designs that enable new approaches to
analytics and operations, creating value for patients and drug developers. To date, the use …

[HTML][HTML] Evaluation of pneumococcal and tetanus vaccine responses in patients with rheumatoid arthritis receiving baricitinib: results from a long-term extension trial …

KL Winthrop, CO Bingham, WJ Komocsar… - Arthritis Research & …, 2019 - Springer
Background Clinical guidelines recommend pneumococcal and tetanus vaccinations in
patients with rheumatoid arthritis (RA). Baricitinib is an oral, selective Janus kinase (JAK) …

[PDF][PDF] Gene expression and pharmacodynamic changes in 1,760 systemic lupus erythematosus patients from two phase III trials of BAFF blockade with tabalumab

RW Hoffman, JT Merrill… - Arthritis & …, 2017 - Wiley Online Library
Objective To characterize baseline gene expression and pharmacodynamically induced
changes in whole blood gene expression in 1,760 systemic lupus erythematosus (SLE) …

Developmental immunotoxicity (DIT) testing of pharmaceuticals: current practices, state of the science, knowledge gaps, and recommendations

M Collinge, LA Burns-Naas, GJ Chellman… - Journal of …, 2012 - Taylor & Francis
The development and regulatory approval of immunomodulatory pharmaceuticals to treat
many human diseases has increased significantly over the last two decades. As discussed …

[HTML][HTML] A qualitative study exploring the health-related quality of life and symptomatic experiences of adults and adolescents with ulcerative colitis

L Newton, JA Randall, T Hunter, S Keith… - Journal of patient …, 2019 - Springer
Background Ulcerative colitis (UC) often first presents during adolescence and early
adulthood. Primary symptoms of UC are well known, yet similarities and differences of …

Immunophenotyping analysis of peripheral blood, splenic, and thymic lymphocytes in male and female rats

DL Morris, WJ Komocsar - Journal of pharmacological and toxicological …, 1997 - Elsevier
A flow cytometry method was used to characterize lymphoid tissue-associated lymphocyte
subsets in the Sprague-Dawley rat. Mononuclear leukocytes from peripheral blood, spleen …

Efficacy and safety of tabalumab, an anti-B-cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to …

JS Smolen, ME Weinblatt, D Van Der Heijde… - Annals of the …, 2015 - ard.bmj.com
Objectives Randomised, double-blind, placebo-controlled study to evaluate efficacy and
safety of tabalumab in patients with rheumatoid arthritis (RA) with inadequate responses to …

Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF …

M Schiff, B Combe, T Dörner, JM Kremer… - RMD open, 2015 - rmdopen.bmj.com
Background Tabalumab is a human monoclonal antibody that neutralises B-cell activating
factor. Objectives To evaluate tabalumab efficacy and safety in patients with rheumatoid …

Acute Lymphoid and Gastrointestinal Toxicity Induced by Selective p38α Map Kinase and Map Kinase–Activated Protein Kinase-2 (MK2) Inhibitors in the Dog

DL Morris, SP O'Neil, RV Devraj… - Toxicologic …, 2010 - journals.sagepub.com
Exposure to moderately selective p38α mitogen-activated protein kinase (MAPK) inhibitors
in the Beagle dog results in an acute toxicity consisting of mild clinical signs (decreased …

[HTML][HTML] A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell-activating factor monoclonal antibody, for rheumatoid arthritis

M Greenwald, L Szczepanski, A Kennedy… - Arthritis Research & …, 2014 - Springer
Introduction The objective of this study was to evaluate the long-term safety and efficacy of
tabalumab, a monoclonal antibody that neutralizes membrane-bound and soluble B-cell …