A5086675147- Rheumatoid Arthritis Research and Therapies
- Autoimmune and Inflammatory Disorders Research
- Biosimilars and Bioanalytical Methods
- Systemic Lupus Erythematosus Research
- Monoclonal and Polyclonal Antibodies Research
- Chronic Lymphocytic Leukemia Research
- Statistical Methods in Clinical Trials
- Advanced Causal Inference Techniques
- Spondyloarthritis Studies and Treatments
- Lymphoma Diagnosis and Treatment
- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical Economics and Policy
- Acute Ischemic Stroke Management
- Stroke Rehabilitation and Recovery
- Tendon Structure and Treatment
- Health Literacy and Information Accessibility
- Sports injuries and prevention
- Antioxidant Activity and Oxidative Stress
- Immunodeficiency and Autoimmune Disorders
- Peripheral Neuropathies and Disorders
- Connective tissue disorders research
- Clinical Laboratory Practices and Quality Control
- Aortic aneurysm repair treatments
- Retinal Imaging and Analysis
- Intracerebral and Subarachnoid Hemorrhage Research
Roche (Switzerland)
2019-2024
Genentech
2014-2015
University of South Florida
2013
University of Leeds
2012
Alcon (United States)
2007
Centra Health
2005
<h3>Importance</h3> More than half of patients with acute ischemic stroke have minor neurologic deficits (National Institutes Health Stroke Scale [NIHSS] score 0-5) at presentation. Although prior major trials alteplase included low NIHSS scores, few without clearly disabling were enrolled. <h3>Objective</h3> To evaluate the efficacy and safety in scores 0 to 5 whose are not disabling. <h3>Design, Setting, Participants</h3> The PRISMS trial was designed as a 948-patient, phase 3b,...
Objective. To investigate the effect of tocilizumab on patient-reported outcomes (PROs) in RA patients with inadequate responses to TNF inhibitors (TNFis). Methods. In a Phase III randomized controlled trial, 489 received 4 or 8 mg/kg placebo every weeks plus MTX for 24 weeks. Mean changes from baseline over time and proportions reporting improvements greater than equal minimum clinically important differences (MCIDs) PROs were analyzed. Results. At week 24, resulted significantly vs pain,...
To assess the safety and tolerability of tocilizumab (TCZ) as monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs (DMARDs) patients moderate to severe rheumatoid arthritis (RA) who had an inadequate response at study entry their current treatment biologic agents DMARDs.This 24-week, multicenter, open-label, phase IIIb conducted US enrolled 886 patients. Treatments were allocated based on therapy entry. Patients receiving assigned TCZ 8 mg/kg monotherapy. All...
<h3>Objective</h3> To examine the imaging-detected mechanism of reduction structural joint damage progression by tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) using MRI. <h3>Methods</h3> In a substudy randomised, double-blind, phase 3b study (ACT-RAY) biologic-naïve RA who were methotrexate (MTX)-inadequate responders, 63 randomised to continue MTX or receive placebo (PBO), both combination TCZ 8 mg/kg every 4 weeks, optional additional disease-modifying antirheumatic drugs at...
Objective To clarify the relevance of measuring interleukin‐6 (IL‐6) and C‐reactive protein (CRP) levels in order to predict clinical response tocilizumab (TCZ) rheumatoid arthritis patients. Methods In a pooled, post hoc analysis 5 pivotal trials TCZ, we examined distributions baseline serum concentrations IL‐6 CRP, stratified by randomized treatment group, week 24 Disease Activity Score 28 joints (DAS28) status (DAS28 <2.6 versus DAS28 ≥2.6). Relationships between early biomarker...
With the emergence of data generated by patient-powered research networks, it is informative to characterize their correspondence with health care system-generated data.This study explored linking 2 disparate sources real-world data: patient-reported from a network (PatientsLikeMe) and insurance claims.Active patients within PatientsLikeMe community, residing in United States, aged 18 years or older, self-reported diagnosis multiple sclerosis Parkinson's disease (PD) were invited participate...
To assess the long-term safety and efficacy of subcutaneous tocilizumab (TCZ-SC) in US patients with rheumatoid arthritis (RA) who rolled over from two global phase 3 studies, SUMMACTA (NCT01194414) BREVACTA (NCT1232569), into this open-label, single-arm, 3b study. Patients continued to receive TCZ-SC 162 mg weekly or every other week switched intravenous TCZ qw for up 84 weeks. The primary endpoint was proportion serious adverse events (SAEs). Secondary endpoints included clinical efficacy,...
The multi-biomarker disease activity (MBDA) score measures 12 proteins involved in the pathophysiology of rheumatoid arthritis (RA) to assess (DA). Previous studies demonstrated correlations between MBDA and clinical DA scores with some RA therapies. In this analysis, relationship changes component biomarkers were evaluated tocilizumab (TCZ)-treated patients. Patients from ACT-RAY study included analysis if they had serum collected at pre-specified time points sufficient for testing ≥1...
The treat-to-target (T2T) approach to the care of patients with rheumatoid arthritis involves using validated metrics measure disease activity, frequent follow-up visits for moderate high and escalation therapy when have inadequate therapeutic response as assessed by standard activity scores. study described is a newly launched cluster-randomized behavioral intervention assess feasibility effectiveness T2T in US rheumatology practices. It designed identify patient provider barriers...
Background The diagnosis of advanced lung cancer is made with minimally invasive procedures. This often results in the availability cytological material only for subtype determination and companion diagnostic testing, latter being technically clinically validated on histological only. Thus, primary objective MO29978 clinical study was to assess programmed death ligand 1 (PD‐L1) protein expression cytology samples as surrogates histology patients cancer. Methods Formalin‐fixed,...
To determine the extent to which disease duration, alone or in combination with other baseline clinical and non-clinical factors, explains variations outcome of tocilizumab initiated biologic-naïve patients established RA.In this pooled analysis phase 3 4 trials conducted by sponsor, predictors response, including demographics, characteristics at (start dosing) study (e.g. patient inclusion criteria, dosing regimen) were evaluated. Response was measured as change from week 24 Clinical...
Rationale Over half of acute ischemic stroke patients have a low National Institutes Health Stroke Scale 0–5 and up to two-thirds may not appear clearly disabled at presentation. The efficacy intravenous alteplase for the latter group is known. Aim Potential rtPA Ischemic Strokes with Mild Symptoms (PRISMS) was designed evaluate safety treatment without disabling deficits. Sample size estimates A maximum 948 subjects were required test superiority hypothesis 80% power, according one-sided...
This post hoc analysis of the TOZURA study programme evaluated efficacy and safety subcutaneous tocilizumab (TCZ-SC) as monotherapy or with concomitant conventional synthetic DMARDs (csDMARDs) in patients RA categorized by baseline glucocorticoid (GC) use.TOZURA was a multinational, open-label, single-arm, common-framework (11 protocols, 22 countries) moderate to severe whom csDMARDs biologic therapies had failed who were MTX naïve. Patients received once-weekly TCZ-SC 162 mg for ⩾24 weeks...
To assess the long-term safety, tolerability, and effectiveness of tocilizumab (TCZ) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) clinical practice patients moderate to severe rheumatoid arthritis (RA).Patients 24-week, open-label ACT-SURE study who had at least a EULAR response by week 24 were from participating country eligible for this extension (LTE); continued receive TCZ 8 mg/kg intravenously every 4 weeks ≥ 1 csDMARD up...
In rheumatoid arthritis (RA) trials, inclusion of patients on background treatment with glucocorticoids (GCs) might impact efficacy and safety outcomes.To determine if GC use influenced outcomes RA randomised clinical trials initiation tocilizumab (TCZ) or adalimumab (ADA) methotrexate (MTX) monotherapy.Data four double-blind controlled (AMBITION, ACT-RAY, ADACTA FUNCTION) in total TCZ, one ADA two MTX monotherapy arms were analysed. Analyses covariance changes from baseline to week 24...
Objective. To evaluate whether patients with rheumatoid arthritis who did not respond sufficiently to tocilizumab (TCZ) plus disease-modifying antirheumatic drug (DMARD) treatment by Week 8 responded at later timepoints when continuing take their original dose of TCZ. Methods. In this posthoc analysis data from phase III randomized controlled trials inadequate responders (IR) DMARD or tumor necrosis factor-α inhibitors (anti-TNF), percentages meeting early response criteria were calculated...
Background We sought to identify immunoglobin G autoantibodies predictive of early treatment response methotrexate, the recommended first-line therapy for patients with newly diagnosed rheumatoid arthritis, and interleukin-6 receptor inhibitor biologic tocilizumab, initiated as first disease-modifying anti-rheumatic drug. Materials methods In baseline sera a subset arthritis in U-Act-Early study, selected based on specific responder/non-responder criteria using Disease Activity Score...
<h3>Background</h3> A treat-to-target (T2T) approach to the care of patients with rheumatoid arthritis (RA) has been advocated, which involves regular assessment disease activity using validated metrics, frequent follow-up visits for moderate high activity, and escalation therapy when have inadequate therapeutic response as assessed by standard scores. <h3>Objectives</h3> The goal this abstract is examine whether cluster randomization will result in comparable a behavioral intervention trial...
Despite the development of new biologic therapies, methotrexate (MTX) remains preferred initial disease-modifying anti-rheumatic drug to treat rheumatoid arthritis (RA). Adherence drugs is suspected be highly variable potentially leading reduced treatment effectiveness. This work aimed develop and validate Methotrexate Experience Questionnaire (MEQ), a tool identify characterize non-adherence oral MTX.
Innovation, defined as the successful implementation at scale of a new invention, is key for continued success drug development enterprise. In this article we focus on statistical innovation in pharmaceutical industry. We discuss both components, invention and scale, typically called commercialization, methods. These concepts are illustrated using three examples that successfully implemented our company. summarize factors foster or hinder commercialization. A discussion mindset consider...