5,542 results match your criteria: "Clinical Development[Affiliation]"

Objectives: To assess immunogenicity and safety in patients with active rheumatoid arthritis (RA) transitioning from rituximab [US-licensed rituximab: Reference Product (RP); EU-approved rituximab: Reference Medicinal Product (RMP)] to DRL_RI (proposed rituximab biosimilar), in comparison to those continuing on RP/RMP.

Methods: This double-blind, randomized, Phase 3 study included 140 RA patients having prior exposure to RP/RMP; transitioned to DRL_RI (n = 70) or continued with RP/RMP (n = 70) for two 1000 mg infusions on Days 1 and 15. Assessments included Time-matched Rituximab Concentration (TMRC), anti-drug antibodies (ADAs), neutralizing antibodies (NAbs) and ADA titre over 12 weeks, and safety follow-up till 26 weeks.

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Article Synopsis
  • - Patients with advanced/metastatic urothelial carcinoma who previously responded to or maintained stable disease with pembrolizumab immunotherapy may benefit from retreatment after disease progression, based on a post hoc analysis involving 49 patients from earlier clinical trials.
  • - The study found that 41% of these patients achieved an objective response following retreatment, with a notable percentage having had a complete response during the initial treatment, and the median duration of the response was around 14 months.
  • - Additionally, the retreatment led to manageable adverse effects, with only 45% experiencing treatment-related events, indicating that pembrolizumab retreatment is a viable and relatively safe option for select patients.
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Biologically defined neuronal synuclein disease as a tool to advance drug development.

NPJ Parkinsons Dis

December 2024

Roche Pharma Research and Early Development (pRED), Roche Innovation Center, F. Hoffmann-La Roche Ltd., Basel, Switzerland.

In a recent Viewpoint article (. 2024;81:789‒90), Okubadejo et al. raised concerns regarding two recent proposals for biological definitions and staging systems for synucleinopathies (the Neuronal Synuclein Disease Integrated Staging System and SynNeurGe system).

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Reduction of postoperative pain and opioid consumption by VVZ-149, first-in-class analgesic molecule: A confirmatory phase 3 trial of laparoscopic colectomy.

J Clin Anesth

December 2024

Department of Anesthesiology and Pain Medicine, Seoul National University, College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address:

Study Objective: VVZ-149 is a small molecule that inhibits the glycine transporter type 2 and the serotonin receptor 5-hydroxytryptamine 2 A. In this Phase 3 study, we investigated the efficacy and safety of VVZ-149 as a single-use injectable analgesic for treating moderate to severe postoperative pain after laparoscopic colectomy.

Design: Randomized, parallel group, double-blind, Phase 3 clinical trial (Trial no.

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This retrospective cohort study evaluated the comparative vaccine effectiveness (cVE) of licensed standard-dose cell-based versus egg-based influenza vaccines in preventing influenza hospitalization among adults 18-64 years during the 2022-2023 season. The cohort included eligible Kaiser Permanente Southern California members who received ≥ 1 dose of influenza vaccine (n = 848,334). The adjusted cVE against influenza hospitalization was -10.

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Aim: To assess weight loss and cardiorenal outcomes by baseline body mass index (BMI) in VERTIS CV.

Methods: Patients with type 2 diabetes and atherosclerotic cardiovascular (CV) disease were randomized to ertugliflozin or placebo. These post hoc analyses evaluated cardiometabolic and cardiorenal outcomes (a composite of death from CV causes or hospitalization for heart failure [HHF], CV death, HHF and an exploratory composite kidney outcome including ≥40% estimated glomerular filtration rate [eGFR] decrease) by baseline BMI, using conventional clinical categories and Cox proportional hazards models.

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Aim: In the PEMA-FL study in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), pemafibrate was shown to significantly decrease low-density lipoprotein cholesterol (LDL-C) levels. We aimed to investigate the mechanisms of pemafibrate-induced LDL-C reduction in patients with MASLD by conducting an additional sub-analysis of the PEMA-FL study.

Methods: The PEMA-FL study randomized 118 patients with MASLD to receive pemafibrate or placebo for 72 weeks.

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Purpose: We developed a hybrid safety surveillance approach for a large, pragmatic clinical trial of a high-dose quadrivalent influenza vaccine (QIV-HD), using both active and passive data collection methods. Here, we present the methods and results for the passive register-based surveillance of serious adverse events (SAEs), which replaced conventional SAE reporting during the trial.

Patients And Methods: The trial recruited over 33,000 older adults of whom 50% received the QIV-HD while the rest received a standard-dose vaccine (QIV-SD) as a control vaccine.

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Background: Commonly, ligand-binding platforms are being used for immunogenicity assessment, but with the recent advent of liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) for protein quantification, this technology has become an alternative for the measurement of anti-drug antibodies (ADAs), when combined with an immunocapture step to extract them out of the biological sample.

Method: The monoclonal antibody adalimumab was immobilized on magnetic beads to isolate ADAs against this drug from serum samples. Multiple repetitions of immunopurification were used to minimize nonspecific binding and improve drug tolerance while maintaining sufficient recovery.

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Hepatitis delta virus (HDV) infection has an aggressive disease course and is the most difficult to treat of the human hepatitis viruses. In Denmark, as in many countries, the national prevalence of HDV has not been established. Based on diagnoses and laboratory test results in national healthcare registries, we estimated that the prevalence of current HDV infection amongst patients with chronic hepatitis B was 3.

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We propose a novel method to adjust for unmeasured time-stable confounding when the time between consecutive treatment administrations is fixed. We achieve this by focusing on a new-user cohort. Furthermore, we envisage that all time-stable confounding goes through the potential time on treatment as dictated by the disease condition at the initiation of treatment.

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Rationale: Unrecognised coronary artery disease (CAD) may contribute to adverse outcomes in chronic obstructive pulmonary disease (COPD). Improved identification of at-risk groups could inform better preventative care. We aimed to evaluate the burden and relationships of radiologically detectable CAD in COPD, establish frequency of occult disease, and examine potential cardiovascular screening methods.

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Background: Nirsevimab is an extended half-life, highly potent neutralizing monoclonal antibody against the respiratory syncytial virus (RSV) fusion protein, with efficacy in preventing RSV-associated medically attended (MA) lower respiratory tract infection (LRTI) in infants and medically vulnerable children (aged ≤24 months). This post-hoc exploratory analysis examined the incidence of LRTI from RSV and other respiratory pathogens during a 2:1 randomized, double-blind, placebo-controlled, phase 3 study of nirsevimab, in healthy-term and late-preterm (i.e.

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Immune persistence following primary vaccination with a single dose of meningococcal quadrivalent conjugate vaccines, MenACYW-TT/MCV4-CRM, at age 10-12 years was demonstrated. Most participants primed with MenACYW-TT and MCV4-CRM maintained seroprotective titers against all serogroups, suggesting continued protection. Priming with MenACYW-TT resulted in higher persistent titers for serogroups C, W, and Y than MCV4-CRM.

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To date, sparse attention has been paid to the importance of the "lived experience" of participants and their caregivers in pediatric gene therapy (GT) trials for rare genetic neurological disorders. Pediatric GT studies differ meaningfully from adult GT studies as the decision to participate involves a dyad: the child participant and their caregiver(s). As a multistakeholder group of authors, we are a diverse group with expert perspectives on the social, emotional, physical, and logistical burdens/benefits of trial participation and the myriad ways they affect pediatric GT research.

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Introduction: Endothelin-1 (ET-1) regulates renal and vascular function, but the clinical utility of selective ET receptor antagonists has been limited due to associated fluid retention. The mechanisms underlying fluid retention remain poorly understood but could be a consequence of changes in ET-1 binding to the unantagonized ET receptor, either through increased ET-1 or non-selective ET.

Methods: A mathematical model of ET-1 kinetics was developed to quantify effects of ET antagonist exposure and selectivity on concentrations of ET-1 and its complexes with ET and ET receptors.

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Introduction: Platinum rechallenge is recommended for patients with small cell lung cancer (SCLC) who relapse ≥90 days after completing first-line chemotherapy, although it may not always be the most suitable option.

Areas Covered: Articles for review were identified via PubMed and ClinicalTrials.gov searches, supplemented with non-indexed publications (e.

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Pulmonary hypertension (PH) is a frequent complication of chronic lung disease (CLD). However, PH is difficult to diagnose early since accompanying symptoms overlap and are similar to those of the underlying CLD. In most cases the PH is mild to moderate and therefore physical signs may be absent or subtle.

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"Natural history of skeletal muscle laminopathies: a 2-year prospective study".

Neuromuscul Disord

November 2024

Neuroimmunology and Neuromuscular Diseases Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy. Electronic address:

Article Synopsis
  • Skeletal muscle laminopathies (SMLs) are rare genetic disorders linked to mutations in the LMNA gene, affecting skeletal muscles.
  • A 2-year study involving 26 patients aimed to understand the progression of SMLs, using various assessments for muscle performance and respiratory function.
  • Results indicated a significant decline in muscle function (NSAA score) and respiratory capacity (FVC and FEV1) over two years, while other measurements like walking tests and joint flexibility remained stable.
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Introduction: Christmas parties, a longstanding Danish tradition, became festive occasions in the 1960s. This study examines if healthcare professionals, especially doctors and nurses, have larger bladder capacities than the general population, as they often delay restroom breaks.

Methods: At the North Zealand University Hospital Department of Anesthesiology's 2023 Christmas party, participants delayed urination until a strong urge occurred.

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Ensuring future-proofing through collaboration.

Br J Nurs

December 2024

Colorectal Clinical Nurse Specialist, University Hospitals Birmingham NHS Trust, and currently Clinical Development Officer, ASCN UK.

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