Clinical trial NCT03465111 - References

Scleritis — A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis

Citation(s)

•   Akpek EK, Thorne JE, Qazi FA, Do DV, Jabs DA
  Evaluation of patients with scleritis for systemic disease. Ophthalmology. 2004 Mar;111(3):501-6. doi: 10.1016/j.ophtha.2003.06.006.
•   Baram TZ, Mitchell WG, Tournay A, Snead OC, Hanson RA, Horton EJ
  High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. Pediatrics. 1996 Mar;97(3):375-9.
•   Bomback AS, Canetta PA, Beck LH Jr, Ayalon R, Radhakrishnan J, Appel GB
  Treatment of resistant glomerular diseases with adrenocorticotropic hormone gel: a prospective trial. Am J Nephrol. 2012;36(1):58-67. doi: 10.1159/000339287. Epub 2012 Jun 19.
•   Brzoska T, Luger TA, Maaser C, Abels C, Bohm M
  Alpha-melanocyte-stimulating hormone and related tripeptides: biochemistry, antiinflammatory and protective effects in vitro and in vivo, and future perspectives for the treatment of immune-mediated inflammatory diseases. Endocr Rev. 2008 Aug;29(5):581-602. doi: 10.1210/er.2007-0027. Epub 2008 Jul 8.
•   Catania A, Gatti S, Colombo G, Lipton JM
  Targeting melanocortin receptors as a novel strategy to control inflammation. Pharmacol Rev. 2004 Mar;56(1):1-29. doi: 10.1124/pr.56.1.1.
•   Catania A, Lonati C, Sordi A, Carlin A, Leonardi P, Gatti S
  The melanocortin system in control of inflammation. ScientificWorldJournal. 2010 Sep 14;10:1840-53. doi: 10.1100/tsw.2010.173.
•   Erkanli L, Akova YA, Guney-Tefekli E, Tugal-Tutkun I
  Clinical features, prognosis, and treatment results of patients with scleritis from 2 tertiary eye care centers in Turkey. Cornea. 2010 Jan;29(1):26-33. doi: 10.1097/ICO.0b013e3181ac9fad.
•   Fiechtner JJ, Montroy T
  Treatment of moderately to severely active systemic lupus erythematosus with adrenocorticotropic hormone: a single-site, open-label trial. Lupus. 2014 Aug;23(9):905-12. doi: 10.1177/0961203314532562. Epub 2014 May 2.
•   Getting SJ
  Targeting melanocortin receptors as potential novel therapeutics. Pharmacol Ther. 2006 Jul;111(1):1-15. doi: 10.1016/j.pharmthera.2005.06.022. Epub 2006 Feb 20.
•   Hladunewich MA, Cattran D, Beck LH, Odutayo A, Sethi S, Ayalon R, Leung N, Reich H, Fervenza FC
  A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (H.P. Acthar(R) Gel) in nephrotic syndrome due to idiopathic membranous nephropathy. Nephrol Dial Transplant. 2014 Aug;29(8):1570-7. doi: 10.1093/ndt/gfu069. Epub 2014 Apr 8.
•   Ichiyama T, Campbell IL, Furukawa S, Catania A, Lipton JM
  Autocrine alpha-melanocyte-stimulating hormone inhibits NF-kappaB activation in human glioma. J Neurosci Res. 1999 Dec 1;58(5):684-9.
•   Jabs DA, Mudun A, Dunn JP, Marsh MJ
  Episcleritis and scleritis: clinical features and treatment results. Am J Ophthalmol. 2000 Oct;130(4):469-76. doi: 10.1016/s0002-9394(00)00710-8.
•   Jachens AW, Chu DS
  Retrospective review of methotrexate therapy in the treatment of chronic, noninfectious, nonnecrotizing scleritis. Am J Ophthalmol. 2008 Mar;145(3):487-492. doi: 10.1016/j.ajo.2007.11.010.
•   Keino H, Watanabe T, Taki W, Nakashima C, Okada AA
  Clinical features and visual outcomes of Japanese patients with scleritis. Br J Ophthalmol. 2010 Nov;94(11):1459-63. doi: 10.1136/bjo.2009.171744. Epub 2010 Jun 24.
•   Kolomeyer AM, Ragam A, Shah K, Do BK, Shah VP, Chu DS
  Cyclo-oxygenase inhibitors in the treatment of chronic non-infectious, non-necrotizing scleritis and episcleritis. Ocul Immunol Inflamm. 2012 Aug;20(4):293-9. doi: 10.3109/09273948.2012.689075. Epub 2012 May 29.
•   Kolomeyer AM, Ragam A, Shah K, Jachens AW, Tu Y, Chu DS
  Mycophenolate mofetil in the treatment of chronic non-infectious, non-necrotizing scleritis. Ocul Immunol Inflamm. 2012 Apr;20(2):113-8. doi: 10.3109/09273948.2012.655398.
•   Krebs EE, Carey TS, Weinberger M
  Accuracy of the pain numeric rating scale as a screening test in primary care. J Gen Intern Med. 2007 Oct;22(10):1453-8. doi: 10.1007/s11606-007-0321-2. Epub 2007 Aug 1.
•   Lee DJ, Taylor AW
  Both MC5r and A2Ar are required for protective regulatory immunity in the spleen of post-experimental autoimmune uveitis in mice. J Immunol. 2013 Oct 15;191(8):4103-11. doi: 10.4049/jimmunol.1300182. Epub 2013 Sep 16.
•   Lee DJ, Taylor AW
  Following EAU recovery there is an associated MC5r-dependent APC induction of regulatory immunity in the spleen. Invest Ophthalmol Vis Sci. 2011 Nov 17;52(12):8862-7. doi: 10.1167/iovs.11-8153.
•   Levine T
  Treating refractory dermatomyositis or polymyositis with adrenocorticotropic hormone gel: a retrospective case series. Drug Des Devel Ther. 2012;6:133-9. doi: 10.2147/DDDT.S33110. Epub 2012 Jun 11. Erratum In: Drug Des Devel Ther. 2012;6:163.
•   Manna SK, Aggarwal BB
  Alpha-melanocyte-stimulating hormone inhibits the nuclear transcription factor NF-kappa B activation induced by various inflammatory agents. J Immunol. 1998 Sep 15;161(6):2873-80.
•   McCluskey PJ, Watson PG, Lightman S, Haybittle J, Restori M, Branley M
  Posterior scleritis: clinical features, systemic associations, and outcome in a large series of patients. Ophthalmology. 1999 Dec;106(12):2380-6. doi: 10.1016/S0161-6420(99)90543-2.
•   Mittal T, Dedhia P, Roy-Chaudhury P, Abu Jawdeh BG, Mogilishetty G, Cuffy MC, Alloway RR, Woodle ES, Govil A
  Complete Remission of Post-transplantation Recurrence of Focal Segmental Glomerulosclerosis With the Use of Adrenocorticotrophic Hormone Gel: Case Report. Transplant Proc. 2015 Sep;47(7):2219-22. doi: 10.1016/j.transproceed.2015.07.013.
•   Montero-Melendez T
  ACTH: The forgotten therapy. Semin Immunol. 2015 May;27(3):216-26. doi: 10.1016/j.smim.2015.02.003. Epub 2015 Feb 26.
•   Okhravi N, Odufuwa B, McCluskey P, Lightman S
  Scleritis. Surv Ophthalmol. 2005 Jul-Aug;50(4):351-63. doi: 10.1016/j.survophthal.2005.04.001.
•   Olsen NJ, Decker DA, Higgins P, Becker PM, McAloose CA, Benko AL, Kovacs WJ
  Direct effects of HP Acthar Gel on human B lymphocyte activation in vitro. Arthritis Res Ther. 2015 Oct 27;17:300. doi: 10.1186/s13075-015-0823-y.
•   Ragam A, Kolomeyer AM, Fang C, Xu Y, Chu DS
  Treatment of chronic, noninfectious, nonnecrotizing scleritis with tumor necrosis factor alpha inhibitors. Ocul Immunol Inflamm. 2014 Dec;22(6):469-77. doi: 10.3109/09273948.2013.863944. Epub 2013 Dec 19.
•   Raiji VR, Palestine AG, Parver DL
  Scleritis and systemic disease association in a community-based referral practice. Am J Ophthalmol. 2009 Dec;148(6):946-50. doi: 10.1016/j.ajo.2009.07.021. Epub 2009 Oct 17.
•   Sainz de la Maza M, Foster CS, Jabbur NS
  Scleritis associated with systemic vasculitic diseases. Ophthalmology. 1995 Apr;102(4):687-92. doi: 10.1016/s0161-6420(95)30970-0.
•   Sainz de la Maza M, Jabbur NS, Foster CS
  Severity of scleritis and episcleritis. Ophthalmology. 1994 Feb;101(2):389-96. doi: 10.1016/s0161-6420(94)31325-x.
•   Sainz de la Maza M, Molina N, Gonzalez-Gonzalez LA, Doctor PP, Tauber J, Foster CS
  Clinical characteristics of a large cohort of patients with scleritis and episcleritis. Ophthalmology. 2012 Jan;119(1):43-50. doi: 10.1016/j.ophtha.2011.07.013. Epub 2011 Oct 2.
•   Sen HN, Sangave AA, Goldstein DA, Suhler EB, Cunningham D, Vitale S, Nussenblatt RB
  A standardized grading system for scleritis. Ophthalmology. 2011 Apr;118(4):768-71. doi: 10.1016/j.ophtha.2010.08.027. Epub 2010 Nov 20.
•   Simsarian JP, Saunders C, Smith DM
  Five-day regimen of intramuscular or subcutaneous self-administered adrenocorticotropic hormone gel for acute exacerbations of multiple sclerosis: a prospective, randomized, open-label pilot trial. Drug Des Devel Ther. 2011;5:381-9. doi: 10.2147/DDDT.S19331. Epub 2011 Jul 11.
•   Star RA, Rajora N, Huang J, Stock RC, Catania A, Lipton JM
  Evidence of autocrine modulation of macrophage nitric oxide synthase by alpha-melanocyte-stimulating hormone. Proc Natl Acad Sci U S A. 1995 Aug 15;92(17):8016-20. doi: 10.1073/pnas.92.17.8016.
•   Tuft SJ, Watson PG
  Progression of scleral disease. Ophthalmology. 1991 Apr;98(4):467-71. doi: 10.1016/s0161-6420(91)32269-3.
•   Watson PG, Hayreh SS
  Scleritis and episcleritis. Br J Ophthalmol. 1976 Mar;60(3):163-91. doi: 10.1136/bjo.60.3.163.
•   Williamson A, Hoggart B
  Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
•   Xing Y, Parker CR, Edwards M, Rainey WE
  ACTH is a potent regulator of gene expression in human adrenal cells. J Mol Endocrinol. 2010 Jul;45(1):59-68. doi: 10.1677/JME-10-0006. Epub 2010 May 11.

An Open Label, Multi-centered, Randomized Phase 2 Study to Evaluate the Safety, Tolerability and Bioactivity of Subcutaneous ACTH GeL in PAtients With Scleritis: The ATLAS Study

Details for clinical trial NCT03465111