Cimzia (certolizumab pegol) / Astellas, UCB 
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  • ||||||||||  Clinical, Review, Journal, Monotherapy:  Efficacy of Monotherapy with Biologics and JAK Inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review. (Pubmed Central) -  Oct 2, 2019   
    Despite recommendations suggesting that biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) should be used in combination with methotrexate in the treatment of rheumatoid arthritis (RA), up to one-third of patients with RA are treated with monotherapy...Forty-four monotherapy studies of abatacept, adalimumab, baricitinib, certolizumab pegol, etanercept, sarilumab, sirukumab, tocilizumab, and tofacitinib reported in 71 publications were identified...There is, however, a need for longer-term head-to-head trials to establish positioning of these interventions in the treatment algorithm for RA. Pfizer.Plain Language Summary: Plain language summary available on the journal website.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
    Clinical, Review, Journal:  Certolizumab pegol for induction of remission in Crohn's disease. (Pubmed Central) -  Sep 27, 2019   
    It is uncertain whether the risk of serious adverse events differs between CZP and placebo as the 95% CI includes the possibility of a small decrease or doubling of events. Future studies are needed to evaluate the long-term efficacy and safety of CZP in CD patients.
  • ||||||||||  Review, Journal:  Baricitinib for Previously Treated Moderate or Severe Rheumatoid Arthritis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. (Pubmed Central) -  Sep 26, 2019   
    The clinical-effectiveness evidence in the CS for BARI was based predominantly on three randomised controlled trials comparing the efficacy of BARI against adalimumab or placebo, as well as one long-term extension study...The company submitted a de novo discrete event simulation model that analysed the incremental cost-effectiveness of BARI versus its comparators for the treatment of RA from the perspective of the National Health Service (NHS) in four different populations: (1) cDMARD-IR patients with moderate RA, defined as a 28-Joint Disease Activity Score (DAS28) > 3.2 and no more than 5.1; (2) cDMARD-IR patients with severe RA (defined as a DAS28 > 5.1); (3) TNFi-IR patients with severe RA for whom rituximab (RTX) was eligible; and (4) TNFi-IR patients with severe RA for whom RTX in combination with methotrexate (MTX) is contraindicated or not tolerated...In the cDMARD-IR population with severe RA, BARI in combination with MTX dominated all comparators except for certolizumab pegol (CTZ) in combination with MTX, with the ICER of CTZ in combination with MTX compared with BARI in combination with MTX estimated to be £18,400 per QALY gained...In the TNFi-IR population with severe RA for whom RTX in combination with MTX is contraindicated or not tolerated, BARI in combination with MTX dominated golimumab in combination with MTX and was less effective and less expensive than the remaining comparators...The programming error that affected the PSA of the severe cDMARD-IR population had only a minimal impact on the results, while the error affecting the severe TNFi-IR RTX-ineligible population resulted in markedly higher costs and QALYs gained for the affected comparators but did not substantially modify the conclusions of the analysis. The NICE Appraisal Committee concluded that BARI in combination with MTX or as monotherapy is a cost-effective use of NHS resources in patients with severe RA, except in TNFi-IR patients who are RTX-eligible.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Trial completion, Trial completion date, Trial primary completion date:  PreCePRA: Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain (clinicaltrials.gov) -  Sep 26, 2019   
    P3,  N=156, Completed, 
    Recruiting --> Completed Recruiting --> Completed | Trial completion date: Jun 2021 --> Jun 2019 | Trial primary completion date: Dec 2020 --> Jun 2019
  • ||||||||||  Clinical, Review, Journal:  Maneuvering Clinical Pathways for Crohn's Disease. (Pubmed Central) -  Sep 16, 2019   
    Patient with inadequate response should have their trough level checked and therapy optimized. Therapeutic prophylaxis for post-operative recurrence should be based on patient's risk factors for recurrence.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
    Review, Journal:  In-label treatment of inflammatory joint diseases (Pubmed Central) -  Sep 11, 2019   
    A further example is that modifying the dose when the treatment goal is reached is only intended for some of the drugs in the course of the disease. Clinical trials which address such questions could help to modify or add to the label, as for example has now been successfully achieved for the treatment with certolizumab in pregnancy.
  • ||||||||||  Inflectra (infliximab biosimilar IV) / Alvogen, Celltrion, Mundipharma, Egis, Nippon Kayaku, Pfizer, Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
    Journal:  Anti-Tumor Necrosis Factor α Therapeutics Differentially Affect Leishmania Infection of Human Macrophages. (Pubmed Central) -  Sep 11, 2019   
    By contrast, we show that blockade of sTNFα by Cimzia does not affect T-cell proliferation and infection rates...Taken together, we provide an in vitro model of human leishmaniasis that allows direct comparison of different anti-TNFα agents. Our results enhance the understanding of the efficacy and adverse effects of TNFα blockers and they contribute to evaluate anti-TNFα therapy for patients living in countries with a high prevalence of leishmaniasis.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Trial completion:  Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) -  Sep 10, 2019   
    P3,  N=110, Completed, 
    Collaboration between surgeons and gastroenterologists appears to be very important to improve the rate of fistula closure. Active, not recruiting --> Completed
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
    Journal:  Oculomotor Nerve Demyelination Secondary to Certolizumab Pegol. (Pubmed Central) -  Aug 30, 2019   
    Further studies are still needed to evaluate the pathophysiology of NAFLD development and disease progression among IBD populations. No abstract available
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
    Journal:  Certolizumab Pegol-Induced Heart Failure. (Pubmed Central) -  Aug 23, 2019   
    Recruiting --> Completed | N=20 --> 41 | Trial completion date: Sep 2015 --> Aug 2019 | Trial primary completion date: Sep 2015 --> Mar 2019 No abstract available
  • ||||||||||  Retrospective data, Journal:  Network meta-analysis of tofacitinib versus biologic treatments in moderate-to-severe rheumatoid arthritis patients. (Pubmed Central) -  Aug 21, 2019   
    All biological DMARDs used in combination with methotrexate, except for etanercept, anakinra, certolizumab and tocilizumab without methotrexate, were displayed ETA on using ACR50 at week 24 in patients naïve to biological DMARDs. Etanercept displayed a greater difference in responses, although the high uncertainty of the comparative results prevented the confirmation of the increased efficacy of this drug.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Trial completion date, Trial primary completion date:  Pediatric Arthritis Study of Certolizumab Pegol (clinicaltrials.gov) -  Aug 20, 2019   
    P3,  N=163, Active, not recruiting, 
    Etanercept displayed a greater difference in responses, although the high uncertainty of the comparative results prevented the confirmation of the increased efficacy of this drug. Trial completion date: Jan 2021 --> Oct 2021 | Trial primary completion date: Dec 2020 --> Jul 2021
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
    Journal:  Certolizumab pegol in the treatment of Takayasu arteritis. (Pubmed Central) -  Aug 15, 2019   
    Side effects included mild infections (n = 5). Our case series suggests that CZP may be an effective and steroid-sparing treatment option in patients with active TA even if they did not previously respond to other TNF inhibitors or tocilizumab.
  • ||||||||||  Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
    Clinical, Journal:  Defining an Optimal Adherence Threshold for Patients Taking Subcutaneous Anti-TNFs for Inflammatory Bowel Diseases. (Pubmed Central) -  Aug 8, 2019   
    Patients who delay refills >2 days on average every 2 weeks of their subcutaneous biologics have significantly increased risk of flare. Further studies to improve adherence among those patients who consistently delay medication use are necessary.Am J Gastroenterol advance online publication, 12 December 2017; doi:10.1038/ajg.2017.438.
  • ||||||||||  Current Treatment Patterns Among Patients With IBD in the U.S. Initiating Biologic Therapy (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_1850;    
    Over an average follow-up of 22.9 months, the mean duration of biologic treatment was 13.5 months (CD: 13.7; UC: 13.1). After 12 and 24 months of treatment, 7.0% (CD: 7.2%; UC: 6.8%) and 11.0% (CD: 11.2%; UC: 10.6%) of patients beginning biologic therapy had undergone surgery for IBD, respectively.
  • ||||||||||  A Case of Hepatosplenic T-cell Lymphoma in a Patient on Vedolizumab for Crohn’s Disease (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_1012;    
    To our knowledge, there have not been reports of HSTCL associated with vedolizumab use nor is there a known mechanism by which vedolizumab could cause HSTCL. In our case, TNF-α inhibitor was stopped 5 years prior and thiopurine analog 1 year prior to diagnosis, raising the question as to how long the risk of HSTCL remains elevated after cessation of such agents.
  • ||||||||||  Peripartum Exposure to Biologic Therapy Does Not Impact Wound Healing After Cesarean Section in Women With Inflammatory Bowel Disease (Stars at Night Ballroom - B2) -  Aug 8, 2019 - Abstract #ACG2019ACG_390;    
    Indications for the 37 C-sections (58%) included: history of perianal disease (n=12, 32%), severely active inflammation (n=1, 3%), ileal pouch anal anastomosis or end ileostomy (n=2, 5%), previous C-section (n=7, 19%), other obstetrical indications (large for gestational age, arrest of labor, malpresentation) (n=14, 38%), or other (n=1, 3%). Twenty six of 37 (70%) women with C-sections were exposed to biologics during pregnancy: infliximab (n=13, 35%), adalimumab (n=5, 14%), ustekinumab (n=3, 8%), vedolizumab (n=4, 11%), and certolizumab (n=1, 3%).
  • ||||||||||  Trial completion date, Trial primary completion date, Checkpoint inhibition:  TICIMEL: TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma (clinicaltrials.gov) -  Aug 8, 2019   
    P1,  N=30, Recruiting, 
    Twenty six of 37 (70%) women with C-sections were exposed to biologics during pregnancy: infliximab (n=13, 35%), adalimumab (n=5, 14%), ustekinumab (n=3, 8%), vedolizumab (n=4, 11%), and certolizumab (n=1, 3%). Trial completion date: Mar 2023 --> Oct 2022 | Trial primary completion date: Jun 2019 --> Dec 2020