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  • ||||||||||  Ibrance (palbociclib) / Pfizer, Vyxeos (cytarabine/daunorubicin liposomal formulation) / Jazz
    Trial completion, Trial completion date, Trial primary completion date:  Phase I/II Trial of CPX-351 + Palbociclib in Patients With Acute Myeloid Leukemia (clinicaltrials.gov) -  Sep 26, 2024   
    P1/2,  N=36, Completed, 
    Phase classification: P1b --> P1 Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Jan 2024 | Trial primary completion date: Jun 2024 --> Jan 2024
  • ||||||||||  Ibrance (palbociclib) / Pfizer, taselisib (GDC-0032) / Roche, pictilisib (GDC-0941) / Roche
    Trial completion, Combination therapy:  PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib (clinicaltrials.gov) -  Sep 26, 2024   
    P1,  N=79, Completed, 
    Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Jan 2024 | Trial primary completion date: Jun 2024 --> Jan 2024 Unknown status --> Completed
  • ||||||||||  hydroxyurea / Generic mfg.
    Enrollment closed, Trial completion date, Trial primary completion date:  ACHiEvE-SCD: Hydroxyurea and EPO in Sickle Cell Disease (clinicaltrials.gov) -  Sep 25, 2024   
    P1/2,  N=17, Active, not recruiting, 
    Unknown status --> Completed Recruiting --> Active, not recruiting | Trial completion date: Aug 2025 --> Mar 2025 | Trial primary completion date: May 2025 --> Dec 2024
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Journal, Real-world evidence, Real-world:  Real-World Clinical Profile of Patients Prescribed Evolocumab in Japan. (Pubmed Central) -  Sep 25, 2024   
    Recruiting --> Active, not recruiting | Trial completion date: Aug 2025 --> Mar 2025 | Trial primary completion date: May 2025 --> Dec 2024 This study provides real-world insights into evolocumab utilization in Japan for optimizing patient care and adherence to guideline-based therapies to better address hypercholesterolemia in Japan.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Review, Journal, HEOR, Metastases:  A systematic review of health-related quality of life outcomes in patients with advanced breast cancer treated with palbociclib. (Pubmed Central) -  Sep 25, 2024   
    Findings were also consistent across key clinical characteristics (visceral metastases, neutropenia), as well as patient populations often underrepresented in clinical trials (Asian patients, older adults). Overall, current evidence suggests that HRQoL is largely preserved with the addition of palbociclib to endocrine therapy in patients with HR+/HER2- aBC or mBC across study types and populations.
  • ||||||||||  Tavneos (avacopan) / Amgen
    Avacopan versus a Prednisone Taper in Patients with ANCA-Associated Vasculitis Without Kidney Involvement in a Phase 3 Trial (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_3658;    
    ADVOCATE was a double-blind, double-dummy, active-controlled trial, with patients randomized 1:1 to receive avacopan (30 mg twice daily) or a prednisone taper (60 mg/day tapered to 0 by week 21) on a background of cyclophosphamide (followed by azathioprine or mycophenolate mofetil) or rituximab. Findings from this post hoc subgroup analysis of ADVOCATE in patients with GPA or MPA without kidney involvement at study baseline demonstrate that avacopan was associated with a numerically higher rate of sustained remission, lower relapse rate, lower GC-related toxicity, greater improvements in HRQoL, and similar safety vs a prednisone taper.
  • ||||||||||  Tavneos (avacopan) / Amgen
    Avacopan versus a Prednisone Taper in Patients with ANCA-Associated Vasculitis and Ear, Nose, or Throat Involvement in a Phase 3 Trial (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_3656;    
    Findings from this post hoc subgroup analysis of ADVOCATE in patients with GPA or MPA and active ENT manifestations at baseline showed that avacopan was associated with faster resolution of ENT manifestations, higher rate of sustained remission, lower relapse rate, lower GC-related toxicity, greater improvement in HRQoL, and similar safety vs a prednisone taper. These data indicate avacopan may be efficacious in patients with ENT involvement of GPA or MPA.
  • ||||||||||  Campath (alemtuzumab) / Sanofi, Neupogen (filgrastim) / Kyowa Kirin, Amgen, Rituxan (rituximab) / Roche
    Improvement Across Multi-organ Domains and Patient Reported Outcomes in Refractory Juvenile-Onset Systemic Sclerosis (jSSc) up to 4 Years After Autologous Stem Cell Transplantation (ASCT) (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_3587;    
    P2
    Conditioning chemoradiation was then administered per an IRB-approved individual treatment plan (Patients 1-3) or per our clinical trial NCT03630211 (Patients 4-7) with rituximab, ATG, total body irradiation 600 cGy with lung and kidney shielding, and cyclophosphamide or thiotepa +/- alemtuzumab... Among our cohort of refractory jSSc patients with moderate to severe disease, ASCT was a safe and effective intervention that provided sustained global disease modifying improvement up to 4 years after transplant with benefit seen as early as 3 months for all patients.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Rheum for Improvement: Screening and Treatment of Glucocorticoid Induced Osteoporosis (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_3526;    
    Clinical FRAX should be considered in patients without recent DXA. Developing population health tools to improve monitoring in this population remains challenging as many data domains in GIOP care require chart validation (true GC use vs.
  • ||||||||||  Prolia (denosumab) / Amgen
    Generation of a Human 3D Bone Model to Mimic Glucocorticoid- induced Osteoporosis In Vitro (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_3509;    
    Ultimately, we obtained an in vitro 3D co-culture of osteoblasts and osteoclasts simulating human native bone capable of mimicking key aspects of GIOP in vitro via treatment with methylprednisolone. As a proof of concept, GIOP was treated with established antiresorptive drugs showing an increase of osteogenesis markers.
  • ||||||||||  Prolia (denosumab) / Amgen
    Study of Bone Metabolism in Patients Diagnosed with Osteogenesis Imperfecta. (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_3503;    
    Nearly all have a history of previous fractures and demonstrate BMD within the range of osteoporosis. The most commonly used treatments are bisphosphonates, being the predominant choices pamidronate in pediatric cases and zoledronic acid in adults.
  • ||||||||||  Tavneos (avacopan) / Amgen
    Baseline Glucocorticoid-Related Toxicity in Newly-Diagnosed and Relapsing ANCA-Associated Vasculitis (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_3350;    
    In ADVOCATE, patients with newly-diagnosed GPA or MPA had GT-SNAPSHOT scores similar to those with relapsing disease, indicating comparable baseline GC-related toxicity. However, the affected GC toxicity domains differed between groups, with GC toxicities associated with chronic GC exposure more commonly seen among patients with relapsing disease and GC toxicities that can develop more rapidly more commonly seen in those with newly-diagnosed disease.
  • ||||||||||  Tavneos (avacopan) / Amgen
    Antineutrophil Cytoplasmic Autoantibody Levels in Patients in the Avacopan Phase 3 Trial (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_3337;    
    The addition of avacopan to rituximab or cyclophosphamide for treatment of GPA or MPA does not appear to impact ANCA levels. The lack of correlation between ANCA levels and outcome of treatment in the ADVOCATE trial suggests that ANCA levels are an unreliable marker of treatment response.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Actemra IV (tocilizumab) / Roche, JW Pharma, Tecvayli (teclistamab-cqyv) / Genmab, J&J
    Safety of Bispecific T-cell Engager Therapy in Autoimmune Disease (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_2895;    
    Treatment with bispecific T-cell engagers had a favorable safety profile in 12 patients with refractory autoimmune disease. Hence, targeting CD19 or BCMA with T cell engagers appears feasible in autoimmune disease and warrants further clinical development.
  • ||||||||||  Praluent (alirocumab) / Sanofi, Regeneron, Leqvio (inclisiran) / Novartis, Repatha (evolocumab) / Amgen, Astellas
    Association Between Small Interfering RNA Therapy and Autoimmune Diseases: U.S. Prospective Cohort Study (In Person) -  Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_2639;    
    Future research should investigate the underlying mechanisms driving this increased risk and evaluate long-term safety across diverse populations. Clinically, monitoring for IBD symptoms in patients receiving inclisiran is recommended to ensure timely intervention and management.