Download PDF
Hamostaseologie 2013; 33(S 01): S56-S60
DOI: 10.1055/s-0037-1619803
Studienmitteilung
Schattauer GmbH

Recruitment update of AHEAD[1]

Long-term registry on joint health and quality of life
Further Information

Publication History

Publication Date:
28 December 2017 (online)

Also available at
    Permissions and Reprints

The multicenter prospective non-interventional AHEAD study was initiated to obtain long-term outcome data on joint health, HR-QoL, haemophilia-related co-morbidities, and the effectiveness and safety of ADVATE (recombinant anti-hemophilic factor VIII, plasma-free method [octocog alfa]) in routine clinical practice.

The German AHEAD study arm aims to enroll up to 500 patients in up to 35 haemo - philia treatment centers (HTCs); patient recruitment started in June 2010. The study arm conducted in other European countries is expected to enroll 350 patients from more than 50 HTCs; recruitment started in June 2011. In both study arms, recruitment will continue through the end of 2015, and each enrolled patient will be followed for a total of four years.

1 ADVATE in HEmophilia A outcome Database


 

  • References

  • 1 Soucie JM, Cianfrini C, Janco RL. et al. Joint rangeof-motion limitations among young males with hemophilia: prevalence and risk factors. Blood 2004; 103: 2467-73.
    CrossrefPubMedGoogle Scholar
  • 2 Brackmann HH, Eickhoff HJ, Oldenburg J, Hammerstein U. Long-term therapy and on-demand treatment of children and adolescents with severe haemophilia A: 12 years of experience. Haemostasis 1992; 22: 251-8.
    PubMedGoogle Scholar
  • 3 Dunn AL. Pathophysiology, diagnosis and prevention of arthropathy in patients with haemophilia. Haemophilia 2011; 17: 571-8.
    CrossrefPubMedGoogle Scholar
  • 4 Valentino LA. Blood-induced joint disease: the pathophysiology of hemophilic arthropathy. J Thromb Haemost 2010; 08: 1895-902.
    CrossrefPubMedGoogle Scholar
  • 5 Den Uijl IE, Fischer K, van der Bom JG. et al. Clinical outcome of moderate haemophilia compared with severe and mild haemophilia. Haemophilia 2009; 15: 83-90.
    CrossrefPubMedGoogle Scholar
  • 6 Klamroth R, Pollmann H, Hermans C. et al. The relative burden of haemophilia A and the impact of target joint development on health-related quality of life: results from the ADVATE Post-Authorization Safety Surveillance (PASS) study. Haemophilia 2011; 17: 412-21.
    CrossrefPubMedGoogle Scholar
  • 7 Aznar JA, Magallon M, Querol F. et al. The orthopaedic status of severe haemophiliacs in Spain. Haemophilia 2000; 06: 170-6.
    CrossrefPubMedGoogle Scholar
  • 8 Fischer K, Bom JG, Mauser-Bunschoten EP. et al. Effects of haemophilic arthropathy on health-related quality of life and socio-economic parameters. Haemophilia 2005; 11: 43-48.
    CrossrefPubMedGoogle Scholar
  • 9 Scalone L, Mantovani LG, Mannucci PM, Gringeri A. Quality of life is associated to the orthopaedic status in haemophilic patients with inhibitors. Haemophilia 2006; 12: 154-62.
    PubMedGoogle Scholar
  • 10 Van Genderen FR, Fischer K, Heijnen L. et al. Pain and functional limitations in patients with severe haemophilia. Haemophilia 2006; 12: 147-53.
    CrossrefPubMedGoogle Scholar
  • 11 Aledort LM, Haschmeyer RH, Pettersson H. A longitudinal study of orthopaedic outcomes for severe factor-VIII-deficient haemophiliacs. The Orthopaedic Outcome Study Group. J Intern Med 1994; 236: 391-9.
    PubMedGoogle Scholar
  • 12 Manco-Johnson MJ, Abshire TC, Shapiro AD. et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med 2007; 357: 535-44.
    CrossrefPubMedGoogle Scholar
  • 13 Valentino LA, Mamonov V, Hellmann A. et al. A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management. J Thromb Haemost 2012; 10: 359-67.
    CrossrefPubMedGoogle Scholar
  • 14 Blanchette VS, Shapiro AD, Liesner RJ. et al. Plasma and albumin-free recombinant factor VIII: pharmacokinetics, efficacy and safety in previously treated pediatric patients. J Thromb Haemost 2008; 06: 1319-26.
    CrossrefPubMedGoogle Scholar
  • 15 Gringeri A, Lundin B, vos MS, Mantovani L, Mannucci PM. A randomized clinical trial of prophylaxis in children with hemophilia A (the ESPRIT Study). J Thromb Haemost 2011; 09: 700-10.
    CrossrefPubMedGoogle Scholar
  • 16 Iorio A, Marchesini E, Marcucci M. et al. Clotting factor concentrates given to prevent bleeding and bleeding-related complications in people with hemophilia A or B. Cochrane Database Syst Rev. 2011; 09: CD003429.
    PubMedGoogle Scholar
  • 17 Oldenburg J, Goudemand J, Valentino L. et al. Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method] demonstrates efficacy, safety and low-risk for immunogenicity in routine clinical practice. Haemophilia 2010; 16: 866-77.
    CrossrefPubMedGoogle Scholar
  • 18 Pollmann H, Klamroth R, Vidovic N. et al. Prophylaxis and quality of life in patients with hemophilia A during routine treatment with ADVATE [antihemophilic factor (recombinant), plasma/albumin-free method] in Germany: a subgroup analysis of the ADVATE PASS post-approval, noninterventional study. Ann Hematol. 2013 doi: 10.1007/s00277-013-1678-4..
    PubMedGoogle Scholar
  • 19 ADVATE Summary of Product Characteristics.
    PubMed
  • 20 Oldenburg J, Kurnik K, Huth-Kühne A. et al. AHEAD. Advate in HaEmophilia A outcome Data-base. Hämostaseologie 2010; 30 (Suppl. 01) S23-S25.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 21 ADVATE European Public Assessment Report (EPAR), Scientific Discussion. 2013 www.ema.eu ropa.eu/docs/en_GB/document_library/ EPAR_-_Scientific_Discussion/human/ 000520/WC500022464.pdf..
    PubMed
  • 22 Gilbert MS. Prophylaxis: musculoskeletal evaluation. Semin Hematol 1993; 30 (03) (Suppl. 02) 3-6.
    PubMedGoogle Scholar
  • 23 Pettersson H, Ahlberg A, Nilsson IM. A radiologic classification of hemophilic arthropathy. Clin Orthop Relat Res 1980; 149: 153-9.
    PubMedGoogle Scholar
  • 24 Lundin B, Pettersson H, Ljung R. A new magnetic resonance imaging scoring method for assessment of haemophilic arthropathy. Haemophilia 2004; 10: 383-9.
    CrossrefPubMedGoogle Scholar
  • 25 Lassila R, Rothschild C, De MP. et al. Recommendations for postmarketing surveillance studies in haemophilia and other bleeding disorders. Haemophilia 2005; 11: 353-9.
    CrossrefPubMedGoogle Scholar
  • 26 Bundesinstitut für Arzneimittel und Medizinprodukte BfArM P-E-IP. Empfehlungen des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehrlich-Instituts zur Planung, Durchführung und Auswertung von Anwendungsbeobachtungen. 2010 www.bfarm.de/DE/Arzneimit tel/1_vorDerZul/klinPr/nichtInterventPruef/nichtInterventPruef-home.html
    PubMedGoogle Scholar
  • 27 Royal S, Schramm W, Berntorp E. et al. Quality-oflife differences between prophylactic and on-demand factor replacement therapy in European haemophilia patients. Haemophilia 2002; 08: 44-50.
    CrossrefPubMedGoogle Scholar
  • 28 Collins PW, Bjorkman S, Fischer K. et al. Factor VIII requirement to maintain a target plasma level in the prophylactic treatment of severe hemophilia A: influences of variance in pharmacokinetics and treatment regimens. J Thromb Haemost 2010; 08: 269-75.
    CrossrefPubMedGoogle Scholar