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]

EUCTR2014-003482-25-ES

/ Not yet recruiting临床2期

A 28 week, randomized, double-blind, placebo-controlled, multi-center, parallel group dose range finding study to assess the effect of monthly doses of bimagrumab 70, 210, and 700 mg on skeletal muscle strength and function in older adults with sarcopenia

开始日期2015-01-30

申办/合作机构

Novartis Farmacéutica SA

EUCTR2014-003032-39-ES

/ Not yet recruiting临床1/2期

A phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive Non-small Cell Lung Cancer

开始日期2014-12-26

申办/合作机构

Novartis Farmacéutica SA

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

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132

项与 Novartis Farmacéutica SA 相关的文献（医药）

2025-03-01·The Patient - Patient-Centered Outcomes Research

Assessing Preferences of Patients with Chronic Spontaneous Urticaria for Injectable Treatment Profiles

Article

作者: Winders, Tonya ; O'Donoghue, James ; Morrison, Samantha ; Lopez-Ortiz, Daniela ; Walsh, Shaun ; Balp, Maria-Magdalena ; Maurer, Marcus ; Mueller, Maike ; Bernstein, Jonathan A ; Kleebach, Jörn ; Giménez-Arnau, Ana Maria ; Danyliv, Andrii

BACKGROUNDIn the context of injectable biologic products approved or in development for chronic spontaneous urticaria (CSU), it is important to capture which treatment attributes matter most to patient and what trade-offs patients are willing to make.OBJECTIVESThe CHOICE-CSU study aimed to quantify patient preferences toward injectable treatment attributes among patients with CSU, inadequately controlled by H1-antihistamines.METHODSThis was a two-phase cross-sectional patient preference study in adult patients with a diagnosis of CSU, inadequately controlled by H1-antihistamines. A qualitative phase collected patients' insights and relevant treatment attributes that mattered to them, and the outputs were used for the quantitative phase to create the actual injectable treatment profiles with attributes and levels such as: efficacy, safety, and mode of administration. The quantitative phase used discrete choice experiment (DCE) methodology. Eligible patients were asked to make hypothetical choices between 12 treatment profile pairs, created by Sawtooth Software^TM. The DCE data were analyzed using hierarchical Bayesian logistic regression models, enabling the quantification of the relative importance of each attribute/level during the decision-making process.RESULTSA total of 450 respondents participated in the DCE. The key attributes driving respondent preference amongst injectable treatment options were type of administration device (relative importance 18.5%), complete control of urticaria (relative importance 17.4%), and resolution of angioedema (relative importance 16.4%). Keeping all other attributes and levels equal, the predicted choice share was higher for a profile with an auto-injector versus one with a pre-filled syringe (72.9% versus 27.1%).CONCLUSIONSThe CHOICE-CSU study is the first study to provide a quantitative assessment of preferences that patients with CSU, inadequately controlled by H1-antihistamines, have for injectable treatment attributes. Symptom-free periods are the most important overriding therapy goal for patients, and patients will accept some inconveniences, such as administration mode, to achieve this. Additionally, when efficacy is equivalent, administration ease of injectable therapies is valued by patients. As new CSU oral treatment options emerge, additional testing of patient preference toward oral treatments will be required.

2025-02-10·Journal of Clinical Oncology

Long-term safety outcomes of ¹⁷⁷ Lu-PSMA-617 in patients with prostate cancer.

作者: Nordquist, Luke ; Saad, Fred ; Kim, Hyun ; Crosby, Michael ; Morgans, Alicia K. ; Herrmann, Ken ; Michalski, Jeff M. ; Sartor, Alton Oliver ; Jobst, Arijana ; Ospina Gonzalez, Diego ; Carnahan, Natalie ; Gupta, Shilpa ; Shore, Neal D. ; Alanee, Shaheen ; Samantray, Sanjay

TPS294Background: Approval of [ 177 Lu]Lu-PSMA-617 ( 177 Lu-PSMA-617) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer, previously treated with androgen receptor pathway inhibitors and taxane-based chemotherapy, was based on the results of the Phase 3 VISION study (NCT03511664). It is important to further characterize long-term safety outcomes in 177 Lu-PSMA-617–treated patients, with particular regard to potential treatment-related risks. To this end, the long-term follow-up (LTFU) safety study (NCT05803941) has been established. Findings from the LTFU study will be crucial for assessing delayed toxicities for patients with PSMA-positive metastatic prostate cancer treated with 177 Lu-PSMA-617 globally. Methods: The LTFU study is a prospective, multi-center, non-EU post-authorization safety study. Patients who received ≥1 dose of 177 Lu-PSMA-617 within one of the prospective parent studies (Table 1) are eligible. Patients may enroll in the LTFU study after fulfilling the requirements of their corresponding parent study. The primary endpoint is the number and proportion of selected adverse events (AEs), including myelosuppression, xerostomia, renal failure, xerophthalmia, and second primary malignancies (eg, myelodysplastic syndrome or acute myeloid leukemia), other serious AEs, and changes in laboratory values. The secondary endpoint is the number and proportion of deaths. Following enrollment, patients will undergo assessments at baseline, and then every 6–8 months for up to 10 years after their first dose of 177 Lu-PSMA-617 or until death. At each visit, a review of selected treatment-related AEs (xerostomia, xerophthalmia, myelosuppression), any-cause AEs (renal toxicity, new diagnoses of second primary malignancies), and treatment-related serious AEs will be conducted. Physical and laboratory assessments, as well as details on concomitant medications and interventions, including anti-cancer therapies, will be collected. Patients may receive treatment with any medical intervention. Interim analyses are planned at 2 and 5 years post-study activation. Enrollment is ongoing (n=13). Clinical trial information: NCT05803941 . Parent studies of the long-term follow-up safety study.TrialIndicationPhaseN (all groups)ClinicalTrials.gov IDVISION (+sub-study)Post-taxane mCRPC3831 (+30)NCT03511664PSMAforePre-taxane mCRPC3469NCT04689828PSMAdditionmHSPC31144NCT04720157177 Lu-PSMA-617 in patients with moderately or severely impaired, or normal renal function Post-taxane mCRPC2 20 aNCT06004661

a Planned. mCRPC, metastatic castration-resistant prostate cancer; mHSPC, metastatic hormone-sensitive prostate cancer.

2024-11-19·Cureus

A Clinical Care Algorithm for Detecting Progression in Multiple Sclerosis: RetratEMos Project

Article

作者: Landete, Lamberto ; García-Domínguez, José M ; Téllez, Nieves ; Garcés, Pilar ; Robles, René ; Meca-Lallana, José E ; Costa-Frossard, Lucienne

OBJECTIVEThe diagnosis of secondary progressive multiple sclerosis (SPMS) is often established retrospectively leading to a delay in detection. This work presents a clinical care algorithm that aims to facilitate the recognition of the secondary progressive phase of the disease, analyzing its usefulness and the feasibility of its implementation in routine clinical practice.METHODSThe algorithm was developed in four phases: 1) choice of validated diagnostic tools for the detection of progression; 2) assessment of these tools based on experience of use, applicability, time consumed, perceived usefulness and suitability for a profile of a patient in transition to SPMS; 3) framework and final sequence of application; 4) feasibility evaluation through application in clinical practice.RESULTSA hierarchical algorithm was developed with an initial screening phase to detect warning signs and establish suspicion of progression (which included the tests "Your Multiple Sclerosis (Your MS)," "MSProDiscuss," and "Nomogram") and a second phase conditional on a positive result in the first, including a functional examination with the Symbol Digit Modalities Test (SDMT), 9-Hole Peg Test (9-HPT), and Timed 25-Foot Walk (T25FW) tools. The algorithm was applied to 373 patients with Expanded Disability Status Scale (EDSS) ≥ 2. The mean time spent per patient in the screening was eight minutes and 20.4 minutes for the complete algorithm. The perceived usefulness of the process by the neurologists was 3.1 (range of 1-4, with 4 being the maximum). In 46% of the cases, the algorithm detected the need for additional functional exploration.CONCLUSIONSFrom our experience, this clinical care algorithm is effective and feasible for detecting progression in MS, although its implementation requires proper organization and can be uneven depending on the resources of each center.

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