Clinical trial NCT02503293 - References

Primary Immunodeficiency — A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push

Citation(s)

•   Al-Herz W, Bousfiha A, Casanova JL, Chapel H, Conley ME, Cunningham-Rundles C, Etzioni A, Fischer A, Franco JL, Geha RS, Hammarström L, Nonoyama S, Notarangelo LD, Ochs HD, Puck JM, Roifman CM, Seger R, Tang ML
  Primary immunodeficiency diseases: an update on the classification from the international union of immunological societies expert committee for primary immunodeficiency. Front Immunol. 2011 Nov 8;2:54. doi: 10.3389/fimmu.2011.00054. eCollection 2011.
•   Al-Herz W, Bousfiha A, Casanova JL, Chatila T, Conley ME, Cunningham-Rundles C, Etzioni A, Franco JL, Gaspar HB, Holland SM, Klein C, Nonoyama S, Ochs HD, Oksenhendler E, Picard C, Puck JM, Sullivan K, Tang ML
  Primary immunodeficiency diseases: an update on the classification from the international union of immunological societies expert committee for primary immunodeficiency. Front Immunol. 2014 Apr 22;5:162. doi: 10.3389/fimmu.2014.00162. eCollection 2014. Erratum in: Front Immunol. 2014;5:460.
•   Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR
  Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004 Feb 26;2:12.
•   Beauté J, Levy P, Millet V, Debré M, Dudoit Y, Le Mignot L, Tajahmady A, Thomas C, Suarez F, Pellier I, Hermine O, Aladjidi N, Mahlaoui N, Fischer A; French PID study group CEREDIH
  Economic evaluation of immunoglobulin replacement in patients with primary antibody deficiencies. Clin Exp Immunol. 2010 May;160(2):240-5. doi: 10.1111/j.1365-2249.2009.04079.x. Epub 2009 Dec 16.
•   Berger M, Murphy E, Riley P, Bergman GE; VIRTUE Trial Investigators
  Improved quality of life, immunoglobulin G levels, and infection rates in patients with primary immunodeficiency diseases during self-treatment with subcutaneous immunoglobulin G. South Med J. 2010 Sep;103(9):856-63. doi: 10.1097/SMJ.0b013e3181eba6ea.
•   Berger M
  Principles of and advances in immunoglobulin replacement therapy for primary immunodeficiency. Immunol Allergy Clin North Am. 2008 May;28(2):413-37, x. doi: 10.1016/j.iac.2008.01.008. Review.
•   Berger M
  Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol. 2004 Jul;112(1):1-7. Review.
•   Brennan VM, Salomé-Bentley NJ, Chapel HM; Immunology Nurses Study
  Prospective audit of adverse reactions occurring in 459 primary antibody-deficient patients receiving intravenous immunoglobulin. Clin Exp Immunol. 2003 Aug;133(2):247-51.
•   Büchi S, Buddeberg C, Klaghofer R, Russi EW, Brändli O, Schlösser C, Stoll T, Villiger PM, Sensky T
  Preliminary validation of PRISM (Pictorial Representation of Illness and Self Measure) - a brief method to assess suffering. Psychother Psychosom. 2002 Nov-Dec;71(6):333-41.
•   Büchi S, Sensky T
  PRISM: Pictorial Representation of Illness and Self Measure. A brief nonverbal measure of illness impact and therapeutic aid in psychosomatic medicine. Psychosomatics. 1999 Jul-Aug;40(4):314-20.
•   Buckley RH, Schiff RI
  The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med. 1991 Jul 11;325(2):110-7. Review.
•   Busse PJ, Razvi S, Cunningham-Rundles C
  Efficacy of intravenous immunoglobulin in the prevention of pneumonia in patients with common variable immunodeficiency. J Allergy Clin Immunol. 2002 Jun;109(6):1001-4.
•   Cassell EJ
  Recognizing suffering. Hastings Cent Rep. 1991 May-Jun;21(3):24-31.
•   Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J
  The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol. 2000 Mar;20(2):94-100.
•   Chapiro, R
  , XIVth Meeting of the European Society for Immunodeficiencies, October 6-9, 2010, Istanbul, Turkey (R-26). 2010.
•   Chérin P, Cabane J
  Relevant criteria for selecting an intravenous immunoglobulin preparation for clinical use. BioDrugs. 2010 Aug 1;24(4):211-23. doi: 10.2165/11537660-000000000-00000. Review.
•   Church JA, Leibl H, Stein MR, Melamed IR, Rubinstein A, Schneider LC, Wasserman RL, Pavlova BG, Birthistle K, Mancini M, Fritsch S, Patrone L, Moore-Perry K, Ehrlich HJ; US-PID-IGIV 10% -Study Group10
  Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency. J Clin Immunol. 2006 Jul;26(4):388-95. Epub 2006 May 17.
•   Cohen, J
  Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ : Erlbaum. 1998.
•   Desai SH, Chouksey A, Poll J, Berger M
  A pilot study of equal doses of 10% IGIV given intravenously or subcutaneously. J Allergy Clin Immunol. 2009 Oct;124(4):854-6. doi: 10.1016/j.jaci.2009.07.051. Epub 2009 Sep 19.
•   Fasth A, Nyström J
  Safety and efficacy of subcutaneous human immunoglobulin in children with primary immunodeficiency. Acta Paediatr. 2007 Oct;96(10):1474-8. Epub 2007 Sep 10.
•   Gardulf A, Andersen V, Björkander J, Ericson D, Frøland SS, Gustafson R, Hammarström L, Jacobsen MB, Jonsson E, Möller G, et al
  Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet. 1995 Feb 11;345(8946):365-9.
•   Gardulf A, Björvell H, Andersen V, Björkander J, Ericson D, Frøland SS, Gustafson R, Hammarström L, Nyström T, Søeberg B, et al
  Lifelong treatment with gammaglobulin for primary antibody deficiencies: the patients' experiences of subcutaneous self-infusions and home therapy. J Adv Nurs. 1995 May;21(5):917-27.
•   Gardulf A, Björvell H, Gustafson R, Hammarström L, Smith CI
  Safety of rapid subcutaneous gammaglobulin infusions in patients with primary antibody deficiency. Immunodeficiency. 1993;4(1-4):81-4.
•   Gardulf A, Björvell H, Gustafson R, Hammarström L, Smith CI
  The life situations of patients with primary antibody deficiency untreated or treated with subcutaneous gammaglobulin infusions. Clin Exp Immunol. 1993 May;92(2):200-4.
•   Gardulf A, Borte M, Ochs HD, Nicolay U; Vivaglobin Clinical Study Group
  Prognostic factors for health-related quality of life in adults and children with primary antibody deficiencies receiving SCIG home therapy. Clin Immunol. 2008 Jan;126(1):81-8. Epub 2007 Oct 26.
•   Gardulf A, Hammarström L, Smith CI
  Home treatment of hypogammaglobulinaemia with subcutaneous gammaglobulin by rapid infusion. Lancet. 1991 Jul 20;338(8760):162-6.
•   Gardulf A, Möller G, Jonsson E
  A comparison of the patient-borne costs of therapy with gamma globulin given at the hospital or at home. Int J Technol Assess Health Care. 1995 Spring;11(2):345-53.
•   Gardulf A, Nicolay U, Asensio O, Bernatowska E, Böck A, Carvalho BC, Granert C, Haag S, Hernández D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M
  Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. Epub 2006 Apr 26.
•   Gardulf A, Nicolay U, Math D, Asensio O, Bernatowska E, Böck A, Costa-Carvalho BT, Granert C, Haag S, Hernández D, Kiessling P, Kus J, Matamoros N, Niehues T, Schmidt S, Schulze I, Borte M
  Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. J Allergy Clin Immunol. 2004 Oct;114(4):936-42.
•   Gardulf A, Nicolay U
  Replacement IgG therapy and self-therapy at home improve the health-related quality of life in patients with primary antibody deficiencies. Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):434-42. Review.
•   Gardulf A
  Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2):105-16. Review.
•   Gaspar J, Gerritsen B, Jones A
  Immunoglobulin replacement treatment by rapid subcutaneous infusion. Arch Dis Child. 1998 Jul;79(1):48-51.
•   Haag, S
  , XIIth Meeting of the European Society for Immunodeficiencies, October 4-7, 2006, Budapest, Hungary. 2012.
•   Haddad L, Perrinet M, Parent D, Leroy-Cotteau A, Toguyeni E, Condette-Wojtasik G, Hachulla E
  [Economic evaluation of at home subcutaneous and intravenous immunoglobulin substitution]. Rev Med Interne. 2006 Dec;27(12):924-6. Epub 2006 Sep 18. French.
•   Hagan JB, Fasano MB, Spector S, Wasserman RL, Melamed I, Rojavin MA, Zenker O, Orange JS
  Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J Clin Immunol. 2010 Sep;30(5):734-45. doi: 10.1007/s10875-010-9423-4. Epub 2010 May 8.
•   Hansen S, Gustafson R, Smith CI, Gardulf A
  Express subcutaneous IgG infusions: decreased time of delivery with maintained safety. Clin Immunol. 2002 Sep;104(3):237-41.
•   Högy B, Keinecke HO, Borte M
  Pharmacoeconomic evaluation of immunoglobulin treatment in patients with antibody deficiencies from the perspective of the German statutory health insurance. Eur J Health Econ. 2005 Mar;6(1):24-9. Erratum in: Eur J Health Econ. 2005 Sep;6(3):243. Eur J Health Econ. 2008 May;9(2):203.
•   Kassardjian CD, Gardner-Nix J, Dupak K, Barbati J, Lam-McCullock J
  Validating PRISM (Pictorial Representation of Illness and Self Measure) as a measure of suffering in chronic non-cancer pain patients. J Pain. 2008 Dec;9(12):1135-43. doi: 10.1016/j.jpain.2008.06.016. Epub 2008 Aug 28.
•   Kittner JM, Grimbacher B, Wulff W, Jäger B, Schmidt RE
  Patients' attitude to subcutaneous immunoglobulin substitution as home therapy. J Clin Immunol. 2006 Jul;26(4):400-5. Epub 2006 Jun 17.
•   Kobrynski L
  Subcutaneous immunoglobulin therapy: a new option for patients with primary immunodeficiency diseases. Biologics. 2012;6:277-87. doi: 10.2147/BTT.S25188. Epub 2012 Aug 24.
•   Liese JG, Wintergerst U, Tympner KD, Belohradsky BH
  High- vs low-dose immunoglobulin therapy in the long-term treatment of X-linked agammaglobulinemia. Am J Dis Child. 1992 Mar;146(3):335-9.
•   Long AA, Denburg JA, Dent PB
  Hypogammaglobulinemia: therapeutic rationale. CMAJ. 1987 Nov 1;137(9):793-7. Review.
•   Martin A, Lavoie L, Goetghebeur M, Schellenberg R
  Economic benefits of subcutaneous rapid push versus intravenous immunoglobulin infusion therapy in adult patients with primary immune deficiency. Transfus Med. 2013 Feb;23(1):55-60. doi: 10.1111/j.1365-3148.2012.01201.x. Epub 2012 Nov 20.
•   Misbah S, Sturzenegger MH, Borte M, Shapiro RS, Wasserman RL, Berger M, Ochs HD
  Subcutaneous immunoglobulin: opportunities and outlook. Clin Exp Immunol. 2009 Dec;158 Suppl 1:51-9. doi: 10.1111/j.1365-2249.2009.04027.x. Review.
•   Mühleisen B, Büchi S, Schmidhauser S, Jenewein J, French LE, Hofbauer GF
  Pictorial Representation of Illness and Self Measure (PRISM): A novel visual instrument to measure quality of life in dermatological inpatients. Arch Dermatol. 2009 Jul;145(7):774-80. doi: 10.1001/archdermatol.2009.121.
•   Nicolay U, Haag S, Eichmann F, Herget S, Spruck D, Gardulf A
  Measuring treatment satisfaction in patients with primary immunodeficiency diseases receiving lifelong immunoglobulin replacement therapy. Qual Life Res. 2005 Sep;14(7):1683-91.
•   Nicolay U, Kiessling P, Berger M, Gupta S, Yel L, Roifman CM, Gardulf A, Eichmann F, Haag S, Massion C, Ochs HD
  Health-related quality of life and treatment satisfaction in North American patients with primary immunedeficiency diseases receiving subcutaneous IgG self-infusions at home. J Clin Immunol. 2006 Jan;26(1):65-72.
•   Nolte MT, Pirofsky B, Gerritz GA, Golding B
  Intravenous immunoglobulin therapy for antibody deficiency. Clin Exp Immunol. 1979 May;36(2):237-43.
•   Nydegger, U
  E., Immunoglobulins chap 18 (pp 260-272) in Rossi's principles of transfusion medicine 4th edn Edited by T.L. Simon 2009.
•   Orange JS, Grossman WJ, Navickis RJ, Wilkes MM
  Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A meta-analysis of clinical studies. Clin Immunol. 2010 Oct;137(1):21-30. doi: 10.1016/j.clim.2010.06.012. Epub 2010 Aug 1.
•   Pourpak Z, Aghamohammadi A, Sedighipour L, Farhoudi A, Movahedi M, Gharagozlou M, Chavoshzadeh Z, Jadid L, Rezaei N, Moin M
  Effect of regular intravenous immunoglobulin therapy on prevention of pneumonia in patients with common variable immunodeficiency. J Microbiol Immunol Infect. 2006 Apr;39(2):114-20.
•   Quinti I, Soresina A, Guerra A, Rondelli R, Spadaro G, Agostini C, Milito C, Trombetta AC, Visentini M, Martini H, Plebani A, Fiorilli M; IPINet Investigators
  Effectiveness of immunoglobulin replacement therapy on clinical outcome in patients with primary antibody deficiencies: results from a multicenter prospective cohort study. J Clin Immunol. 2011 Jun;31(3):315-22. doi: 10.1007/s10875-011-9511-0. Epub 2011 Mar 2.
•   Radinsky S, Bonagura VR
  Subcutaneous immunoglobulin infusion as an alternative to intravenous immunoglobulin. J Allergy Clin Immunol. 2003 Sep;112(3):630-3.
•   Remvig L, Andersen V, Hansen NE, Karle H
  Prophylactic effect of self-administered pump-driven subcutaneous IgG infusion in patients with antibody deficiency: a triple-blind cross-over study comparing P-IgG levels of 3 g l-1 versus 6 g l-1. J Intern Med. 1991 Jan;229(1):73-7.
•   Roifman CM, Lederman HM, Lavi S, Stein LD, Levison H, Gelfand EW
  Benefit of intravenous IgG replacement in hypogammaglobulinemic patients with chronic sinopulmonary disease. Am J Med. 1985 Aug;79(2):171-4.
•   Shapiro R
  Subcutaneous immunoglobulin therapy by rapid push is preferred to infusion by pump: a retrospective analysis. J Clin Immunol. 2010 Mar;30(2):301-7. doi: 10.1007/s10875-009-9352-2. Epub 2010 Jan 15.
•   Shapiro RS
  Subcutaneous immunoglobulin therapy given by subcutaneous rapid push vs infusion pump: a retrospective analysis. Ann Allergy Asthma Immunol. 2013 Jul;111(1):51-5. doi: 10.1016/j.anai.2013.04.015. Epub 2013 May 22.
•   Shapiro RS
  Subcutaneous immunoglobulin: rapid push vs. infusion pump in pediatrics. Pediatr Allergy Immunol. 2013 Feb;24(1):49-53. doi: 10.1111/pai.12026.
•   Shapiro RS
  Why I use subcutaneous immunoglobulin (SCIG). J Clin Immunol. 2013 Jan;33 Suppl 2:S95-8. doi: 10.1007/s10875-012-9853-2. Epub 2012 Dec 21. Review.
•   Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, Bichler J; IgPro10 in PID study group
  Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol. 2009 Jan;29(1):137-44. doi: 10.1007/s10875-008-9231-2. Epub 2008 Sep 24.
•   Streffer ML, Büchi S, Mörgeli H, Galli U, Ettlin D
  PRISM (pictorial representation of illness and self measure): a novel visual instrument to assess pain and suffering in orofacial pain patients. J Orofac Pain. 2009 Spring;23(2):140-6.
•   Tcheurekdjian H, Palermo T, Hostoffer R
  Quality of life in common variable immunodeficiency requiring intravenous immunoglobulin therapy. Ann Allergy Asthma Immunol. 2004 Aug;93(2):160-5.
•   Töndury B, Muehleisen B, Ballmer-Weber BK, Hofbauer G, Schmid-Grendelmeier P, French L, Büchi S
  The Pictorial Representation of Illness and Self Measure (PRISM) instrument reveals a high burden of suffering in patients with chronic urticaria. J Investig Allergol Clin Immunol. 2011;21(2):93-100.
•   Waniewski J, Gardulf A, Hammarström L
  Bioavailability of gamma-globulin after subcutaneous infusions in patients with common variable immunodeficiency. J Clin Immunol. 1994 Mar;14(2):90-7.
•   Ware, J
  , Snow, KK, Kosinski M, Gandek B, SF-36 Health Survey: a manual and interpretation guide. Boston, MA. The Heath Institute, New England Medical Centre. 1993.
•   Wasserman RL, Church JA, Stein M, Moy J, White M, Strausbaugh S, Schroeder H, Ballow M, Harris J, Melamed I, Elkayam D, Lumry W, Suez D, Rehman SM
  Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (IVIG) in patients with primary immunodeficiency. J Clin Immunol. 2012 Aug;32(4):663-9. doi: 10.1007/s10875-012-9656-5. Epub 2012 Mar 6.
•   Winkelstein JA, Conley ME, James C, Howard V, Boyle J
  Adults with X-linked agammaglobulinemia: impact of disease on daily lives, quality of life, educational and socioeconomic status, knowledge of inheritance, and reproductive attitudes. Medicine (Baltimore). 2008 Sep;87(5):253-8. doi: 10.1097/MD.0b013e318187ed81.
•   Wittmann L, Schnyder U, Büchi S
  PRISM (Pictorial Representation of Illness and Self Measure): a new method for the assessment of suffering after trauma. J Trauma Stress. 2012 Feb;25(1):94-7. doi: 10.1002/jts.20710. Epub 2012 Jan 25.
•   Wouters EJ, Reimus JL, van Nunen AM, Blokhorst MG, Vingerhoets AJ
  Suffering quantified? Feasibility and psychometric characteristics of 2 revised versions of the Pictorial Representation of Illness and Self Measure (PRISM). Behav Med. 2008 Summer;34(2):65-78. doi: 10.3200/BMED.34.2.65-78.

A Randomised, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push

Details for clinical trial NCT02503293