1.在中国真实世界人群中，基于年复发率描述BAF312在复发型多发性硬化(RMS)患者中的有效性。 2.描述开始BAF312治疗后12个月时保持无复发的患者比例。 3.在中国真实世界人群中描述BAF312在RMS患者中的安全性特征。 4.描述开始BAF312治疗后12个月时无MRI活动性的患者比例。

开始日期2023-04-23

申办/合作机构

Novartis Farmacéutica SA

[+3]

EUCTR2022-002691-36-ES / Unknown status临床3期

A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)

开始日期2022-12-22

申办/合作机构

Novartis Farmacéutica SA

EUCTR2021-004601-47-ES / Unknown status临床3期

A multi-center, randomized, double-blind, placebo controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE) - VICTORION-PLAQUE

开始日期2022-07-12

申办/合作机构

Novartis Farmacéutica SA

100 项与 Novartis Farmacéutica SA 相关的临床结果

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0 项与 Novartis Farmacéutica SA 相关的专利（医药）

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119

项与 Novartis Farmacéutica SA 相关的文献（医药）

2024-07-01·Actas Dermo-Sifiliográficas

Validación de la versión española del cuestionario PURE-4 para la detección precoz de la artritis psoriásica en pacientes con psoriasis

Article

作者: Queiro-Silva, R ; Belinchón-Romero, I ; de la Cueva-Dobao, P ; Rodríguez Fernández-Freire, L ; Santos-Juanes, J ; Vidal-Sarro, D ; Ferrán I Farrés, M ; López-Ferrer, A ; Rivera-Díaz, R ; Gómez-Labradror, L ; Martín-Vázquez, V ; Rocamora-Durán, V

BACKGROUND AND OBJECTIVEPsoriasis often precedes the onset of psoriatic arthritis (PsA), so dermatologists often face the challenge of early identifying signs of PsA in patients with psoriasis. Our aim was to validate the Spanish version of the PURE-4 questionnaire as a screening tool for PsA, evaluate its performance in terms of sensitivity, specificity, feasibility, reliability, and build validity.METHODSThis was a cross-sectional, observational, multicenter trial of adult patients with psoriasis. Initially, patients were assessed by a dermatologist and completed 2 self-administered versions (in print and online) of the PURE-4 questionnaire. Afterwards, the rheumatologist, blinded to the PURE-4 results, assessed the presence/absence of PsA, being the reference to determine the performance of the PURE-4 questionnaire.RESULTSA total of 268 patients were included (115 [42.9%] women; mean age, 47.1±12.6). The prevalence of PsA according to rheumatologist diagnosis was 12.7% (34 patients). The mean PURE-4 score for patients with psoriasis diagnosed with PsA was 2.3±1.1, and 1.3±1.3 for patients without PsA (P<.001). The cutoff value ≥2 demonstrated the best performance for detecting PsA, with a negative predictive value of 95.1% (95% confidence interval, 90.3-97.6).CONCLUSIONSThe PURE-4 questionnaire demonstrated good performance in detecting PsA, with an optimal cutoff point ≥2. This simple tool could facilitate early referral of patients to the rheumatology unit.

2024-07-01·Actas Dermo-Sifiliográficas

[Translated article] Validation of the Spanish Version of the PURE-4 Questionnaire for the Early Detection of Psoriatic Arthritis in Psoriatic Patients

Article

作者: Queiro-Silva, R ; Rodríguez Fernández-Freire, L ; de la Cueva-Dobao, P ; Santos-Juanes, J ; Vidal-Sarro, D ; Belinchón-Romero, I ; Ferrán I Farrés, M ; López-Ferrer, A ; Rivera-Díaz, R ; Martín-Vázquez, V ; Gómez-Labradror, L ; Rocamora-Durán, V

2024-03-01·Alzheimer's & Dementia

Effects of the active amyloid beta immunotherapy CAD106 on PET measurements of amyloid plaque deposition in cognitively unimpaired APOE ε4 homozygotes

Article

作者: Ricart, Javier ; Langbaum, Jessica B ; Graf, Ana ; Riviere, Marie-Emmanuelle ; Meneses, Kathleen ; Cazorla, Pilar ; Reiman, Eric M ; Turner, R Scott ; Caputo, Angelika ; Tariot, Pierre N ; Sui, Yihan ; Rinne, Juha O

AbstractINTRODUCTIONAlzheimer's Prevention Initiative Generation Study 1 evaluated amyloid beta (Aβ) active immunotherapy (vaccine) CAD106 and BACE‐1 inhibitor umibecestat in cognitively unimpaired 60‐ to 75‐year‐old participants at genetic risk for Alzheimer's disease (AD). The study was reduced in size and terminated early. Results from the CAD106 cohort are presented.METHODSSixty‐five apolipoprotein E ε4 homozygotes with/without amyloid deposition received intramuscular CAD106 450 μg (n = 42) or placebo (n = 23) at baseline; Weeks 1, 7, 13; and quarterly; 51 of them had follow‐up Aβ positron emission tomography (PET) scans at 18 to 24 months.RESULTSCAD106 induced measurable serum Aβ immunoglobulin G titers in 41/42 participants, slower rates of Aβ plaque accumulation (mean [standard deviation] annualized change from baseline in amyloid PET Centiloid: −0.91[5.65] for CAD106 versus 8.36 [6.68] for placebo; P < 0.001), and three amyloid‐related imaging abnormality cases (one symptomatic).DISCUSSIONDespite early termination, these findings support the potential value of conducting larger prevention trials of Aβ active immunotherapies in individuals at risk for AD.Highlights

This was the first amyloid‐lowering prevention trial in persons at genetic risk of late‐onset Alzheimer's disease (AD).

Active immunotherapy targeting amyloid (CAD106) was tested in this prevention trial.

CAD106 significantly slowed down amyloid plaque deposition in apolipoprotein E homozygotes.

CAD106 was generally safe and well tolerated, with only three amyloid‐related imaging abnormality cases (one symptomatic).

Such an approach deserves further evaluation in larger AD prevention trials.

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