CR100967 : Essai de phase 3 randomisé, en double aveugle, évaluant l’efficacité et la tolérance de l’ibrutinib (PCI-32765), inhibiteur de la tyrosine kinase de Bruton (BTK), en association avec la bendamustine et le rituximab, chez des patients âgés ayant un lymphome à cellules du manteau nouvellement diagnostiqué. [Informations issues du site clinicaltrials.gov et traduites par l'INCa] [essai clos aux inclusions] L’objectif de cet essai est d’évaluer l’efficacité et la tolérance de l’ibrutinib en association avec de la bendamustine et du rituximab, chez des patients âgés de 65 ans ou plus présentant un lymphom...

• Pays France
• Organes Lymphomes non hodgkinien
• Spécialités Thérapies Ciblées, Gériatrie

AN EXPLORATORY TRIAL TO ASSESS NATURALISTIC SAFETY AND EFFICACY OUTCOMES IN PATIENTS TRANSITIONED TO USTEKINUMAB FROM PREVIOUS METHOTREXATE THERAPY (TRANSIT) The primary objective of this exploratory trial is to evaluate the comparative safety through week 12 of two treatment transition strategies in patients with inadequate response to methotrexate: disco...

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Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure The primary objective of this study is to evaluate whether treatment with nesiritide improves patient outcomes (as measured by reduction in the composite of HF rehospitalization and all-cause mortalit...

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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase-5 Inhibitor The primary objective is to determine the efficacy of dapoxetine (30/60 mg prn) compared with placebo after 12 weeks of treatment in prolonging IELT (intravaginal ejaculatory latency time) in men with...

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An efficacy and safety study of Telaprevir in patients with genotype 1 Hepatitis C infection after liver transplantation to determine the efficacy of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in genotype 1 chronic HCV infected liv...

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Lab School Day Study for CONCERTA of Older Children with ADHD The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with attention defic...

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A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Refractory Partial Seizures The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 (100, 300, 800, and 1,600 mg) as adjunctive treatment of refractory partial epi...

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Use of a Gamma-IFN Assay in Contact Tracing for Tuberculosis in a Low-Incidence, High Immigration Area After exposure to an active case of tuberculosis (TB), close contacts may be infected. They are then considered as having latent tuberculosis infection (LTBI). Detecting LTBI is the main g...

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A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy The primary objective is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA in subjects with active RA who are refractory to an anti-TNF alpha agent.

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• Organes Aucun
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A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Participants With Influenza A Infection The primary objective is to evaluate the pharmacokinetic (PK) parameters of JNJ-63623872 in combination with oseltamivir in elderly subjects (aged 65 to ≤85 years) compared to adults (aged 18 to ≤64 y...

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