- |||||||||| Orencia (abatacept) / BMS, Actemra IV (tocilizumab) / Roche, JW Pharma
Enrollment closed, Enrollment change: MAZERATI: Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept (clinicaltrials.gov) - Jun 3, 2019 P4, N=10, Active, not recruiting, Recruiting --> Active, not recruiting | N=90 --> 10
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Biomarker, Review, Journal: Pre-Treatment Biomarkers of Anti-Tumour Necrosis Factor Therapy Response in Crohn's Disease-A Systematic Review and Gene Ontology Analysis. (Pubmed Central) - May 31, 2019 Our gene ontology analysis shows that these networks have roles in apoptotic signalling, response to oxidative stress and inflammation pathways. We conclude that a more systematic approach with genome-wide search of genomic and expression biomarkers in the same patients is needed in future studies.
- |||||||||| Journal: Management of Inflammatory Arthritis in pregnancy: a National Cross-Sectional Survey of Canadian rheumatologists. (Pubmed Central) - May 31, 2019
There was consensus with use of 4 biologics - adalimumab (81%), certolizumab (80%), etanercept (83%), and infliximab (76%) - in planned pregnancies but uncertainty on when they should be discontinued and their use in unplanned pregnancies. This national survey shows consensus among rheumatologists on the use of some csDMARDs and biologics/small molecules in IA patients planning pregnancy but varied knowledge on when to discontinue and what to do in unplanned pregnancies.
- |||||||||| Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal: A Randomized, Double-blind, Placebo-controlled Trial of Certolizumab Pegol in Women with Refractory Interstitial Cystitis/Bladder Pain Syndrome. (Pubmed Central) - May 29, 2019 Women with moderate to severe refractory IC/BPS were more likely to experience significant improvement in symptoms with certolizumab pegol compared with placebo therapy. Further investigation of certolizumab pegol for the treatment of IC/BPS is warranted with a larger, longer, multicenter, randomized, placebo-controlled trial.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, Journal: Risk of Serious Bacterial Infection Associated With Tumor Necrosis Factor-Alpha Inhibitors in Children and Young Adults With Inflammatory Bowel Disease. (Pubmed Central) - May 26, 2019 Among TNFI users, certolizumab showed a 3.38-fold (95% CI, 2.25-5.09) increased risk vs infliximab, and subcutaneously administered TNFIs also exhibited a higher risk (HR, 1.34; 95% CI, 1.18-1.53) than intravenous TNFIs. TNFIs pose a higher risk of serious infection compared with immunomodulators in children and young adults with IBD, and this risk differs among individual TNFIs and routes of administration.
- |||||||||| Clinical, Review, Journal: Recommendations for Initiating Systemic Therapy in Patients with Psoriasis. (Pubmed Central) - May 25, 2019
The authors discuss the barriers to use of systemic agents and highlight the central importance of each patient's perspective when assessing disease severity. Additionally, practical strategies for selecting and safely initiating systemic therapy to optimize the treatment of patients with psoriasis are identified.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Clinical, P3 data, Journal, Combination therapy: Efficacy and safety of certolizumab pegol in combination with methotrexate in methotrexate-inadequate responder Chinese patients with active rheumatoid arthritis: 24-week results from a randomised, double-blind, placebo-controlled phase 3 study. (Pubmed Central) - May 17, 2019 Additionally, practical strategies for selecting and safely initiating systemic therapy to optimize the treatment of patients with psoriasis are identified. CZP in combination with MTX showed an acceptable safety profile, a rapid onset of response and sustained effects in reducing the signs and symptoms of RA and improving physical function in Chinese patients with RA and an inadequate response to MTX.
- |||||||||| Review, Journal: Biologics in SAPHO syndrome: A systematic review. (Pubmed Central) - Apr 26, 2019
In SAPHO patients not responding to conventional treatment, TNF blockers appear to be the first choice. In patients failing TNF blockers, IL-1 inhibitors and biologics targeting the IL-17/IL-23 axis could be used.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, UCB
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Certolizumab in Combination With Chemotherapy for Patients With Stage IV Lung Adenocarcinomas (clinicaltrials.gov) - Apr 24, 2019 P1, N=30, Active, not recruiting, In patients failing TNF blockers, IL-1 inhibitors and biologics targeting the IL-17/IL-23 axis could be used. Trial completion date: Apr 2019 --> Apr 2020 | Trial primary completion date: Apr 2019 --> Apr 2020
- |||||||||| Cimzia (certolizumab pegol) / Astellas, UCB
Trial completion date, Trial primary completion date: Pediatric Arthritis Study of Certolizumab Pegol (clinicaltrials.gov) - Apr 20, 2019 P3, N=163, Active, not recruiting, Trial completion date: Apr 2019 --> Apr 2020 | Trial primary completion date: Apr 2019 --> Apr 2020 Trial completion date: Jul 2021 --> Jan 2021 | Trial primary completion date: Apr 2021 --> Dec 2020
- |||||||||| Journal, HEOR: Cost-effectiveness analysis of secukinumab in ankylosing spondylitis from the Canadian perspective. (Pubmed Central) - Apr 14, 2019
This analysis demonstrates that secukinumab 150 mg is the most cost-effective treatment option for biologic-naïve AS patients compared to certolizumab pegol, adalimumab, golimumab, etanercept and etanercept biosimilar, and infliximab and infliximab biosimilar for a lifetime horizon in Canada. Treatment with secukinumab translates into substantial benefits for patients and the healthcare system.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Preclinical, Journal: Ameliorative effect of certolizumab on experimentally induced acute necrotic pancreatitis in rats. (Pubmed Central) - Apr 5, 2019 Since all of these cases had Crohn's disease or rheumatoid arthritis as the underlying disease, this is the first case report of certolizumab-pegol induced psoriasiform eruption in a patient with ankylosing spondylitis, to the best of our knowledge. The results support the idea that certolizumab might be beneficial for the severity of AP.
- |||||||||| Remicade (infliximab) / Mitsubishi Tanabe, J&J, Humira (adalimumab) / Eisai, AbbVie, Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Journal: Drug Induced Thrombotic Microangiopathy with Certolizumab Pegol. (Pubmed Central) - Mar 25, 2019 In our case, we are stressing on the mechanism of DITMA by a probable immune mediated and autoimmune process due to an antibody. Anti-drug antibodies and their immunological aspects are still unclear and awaiting to be elucidated.
- |||||||||| Cimzia (certolizumab pegol) / Astellas, UCB
Clinical, Journal, Real-world evidence: Challenges in Using Real-world Clinical Practice Records for Validation of Clinical Trial Data in Inflammatory Bowel Disease: Lessons Learned. (Pubmed Central) - Mar 23, 2019 We describe the limitations of an EMR in our attempt to conduct a seemingly simple study aimed at validating variables identified in the PRECiSE 3, a 7-year open label safety and efficacy study of certolizumab pegol in Crohn's disease that identified clinical factors that predicted both short- and long-term efficacy...Significant challenges with reliable capture of key data elements were encountered, and overall a screen fail rate of 91.8% across all sites was seen. We describe these challenges and potential future directions to work together to advance accuracy and implementation of the use of EMRs in inflammatory bowel disease.
- |||||||||| Clinical, Journal, Combination therapy: Evaluation of the efficacy and safety of sarilumab combination therapy in patients with rheumatoid arthritis with inadequate response to conventional disease-modifying antirheumatic drugs or tumour necrosis factor α inhibitors: systematic literature review and network meta-analyses. (Pubmed Central) - Mar 20, 2019
...Against most targeted DMARDs, sarilumab 200 mg showed no statistically significant differences, except superiority to baricitinib 2 mg, tofacitinib and certolizumab on 24 week mTSS...TNFi-IR: Sarilumab 200 mg was similar to abatacept, golimumab, tocilizumab 4 mg and 8 mg/kg intravenously and rituximab on ACR20/50/70, superior to baricitinib 2 mg on ACR50 and DAS28<2.6 and to abatacept, golimumab, tocilizumab 4 mg/kg intravenously and rituximab on DAS28<2.6...Serious adverse events, including serious infections, appeared similar for sarilumab versus comparators. Results suggest that in csDMARD-IR and TNFi-IR (a smaller network), sarilumab+csDMARD had superior efficacy and similar safety versus placebo+csDMARDs and at least similar efficacy and safety versus other targeted DMARDs+csDMARDs.
- |||||||||| Bimzelx (bimekizumab) / UCB, Cimzia (certolizumab pegol) / Astellas, UCB
Enrollment closed: A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis (clinicaltrials.gov) - Mar 7, 2019 P2a, N=76, Active, not recruiting, Adalimumab, golimumab, and infliximab were associated with higher efficacy and lower incremental costs per responder for both joint and skin responses in active PsA. Recruiting --> Active, not recruiting
- |||||||||| Cimzia (certolizumab pegol) / Astellas, UCB
Trial completion date, Trial primary completion date: Pediatric Arthritis Study of Certolizumab Pegol (clinicaltrials.gov) - Feb 11, 2019 P3, N=163, Active, not recruiting, Recruiting --> Active, not recruiting Trial completion date: May 2019 --> Jul 2021 | Trial primary completion date: Feb 2019 --> Apr 2021
- |||||||||| Orencia (abatacept) / BMS, Actemra IV (tocilizumab) / Roche, JW Pharma, Cimzia (certolizumab pegol) / Astellas, UCB
Enrollment closed: NORD-STAR: Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction (clinicaltrials.gov) - Dec 24, 2018 P4, N=812, Active, not recruiting, Trial primary completion date: Oct 2018 --> Oct 2020 Recruiting --> Active, not recruiting
- |||||||||| Cimzia (certolizumab pegol) / Astellas, UCB
Trial completion date, Trial primary completion date: Study of Cimzia for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - Dec 7, 2018 P2, N=25, Active, not recruiting, Trial completion date: Sep 2019 --> Jun 2020 | Trial primary completion date: Dec 2018 --> Jun 2019 Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019
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