Giant Cells Arteritis Clinical Trial
— BioACGOfficial title:
Biomarkers in Giant Cells Arteritis
| Verified date | April 2019 |
| Source | University Hospital, Grenoble |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is
the most frequent vasculitis of the population over the age of 50. This vasculitis is at the
origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes.
Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp
hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with
the possibility to go blind. Until now, the standard treatment is a high dosage
corticosteroid therapy.
Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990.
The relapse rate is important, ranging from 10 to 64 % according to studies. There are also
issues of becoming dependent on steroid.
So it is important to determine new diagnosis markers and a therapeutic following of giant
cells arteritis.
With this study several biomarkers of inflammation will be studied in order to determine if
one ore many of them have a good sensitivity and special feature for diagnosis and following
of giant cells arteritis.
The main goal is to determine a new diagnosis marker for giant cells arteritis.
| Status | Terminated |
| Enrollment | 100 |
| Est. completion date | January 14, 2019 |
| Est. primary completion date | January 14, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patient suffering from giant cells arteritis. - Inclusion while discovery of symptoms, or during relapse. Exclusion Criteria: - Healthy volunteer - Treatment with corticosteroid since more than 8 days for a patient suffering from giant cells arteritis, exept for patients under corticosteroid for a polymyalgia rheumatica. - Other diseases than giant cells arteritis that could introduce an inflammatory symptom, especially a tumoral process in progress or a chronic inflammatory disease (any other one than giant cells arteritis) |
| Country | Name | City | State |
|---|---|---|---|
| France | UniversityHospitalGrenoble | La Tronche |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
Alba MA, García-Martínez A, Prieto-González S, Tavera-Bahillo I, Corbera-Bellalta M, Planas-Rigol E, Espígol-Frigolé G, Butjosa M, Hernández-Rodríguez J, Cid MC. Relapses in patients with giant cell arteritis: prevalence, characteristics, and associated clinical findings in a longitudinally followed cohort of 106 patients. Medicine (Baltimore). 2014 Jul;93(5):194-201. doi: 10.1097/MD.0000000000000033. — View Citation
Blume JD. Bounding Sample Size Projections for the Area Under a ROC Curve. J Stat Plan Inference. 2009 Mar 1;139(1):711-721. — View Citation
García-Martínez A, Hernández-Rodríguez J, Espígol-Frigolé G, Prieto-González S, Butjosa M, Segarra M, Lozano E, Cid MC. Clinical relevance of persistently elevated circulating cytokines (tumor necrosis factor alpha and interleukin-6) in the long-term followup of patients with giant cell arteritis. Arthritis Care Res (Hoboken). 2010 Jun;62(6):835-41. doi: 10.1002/acr.20043. — View Citation
Graham E, Holland A, Avery A, Russell RW. Prognosis in giant-cell arteritis. Br Med J (Clin Res Ed). 1981 Jan 24;282(6260):269-71. — View Citation
Hachulla E, Boivin V, Pasturel-Michon U, Fauchais AL, Bouroz-Joly J, Perez-Cousin M, Hatron PY, Devulder B. Prognostic factors and long-term evolution in a cohort of 133 patients with giant cell arteritis. Clin Exp Rheumatol. 2001 Mar-Apr;19(2):171-6. — View Citation
Hachulla E, Saile R, Parra HJ, Hatron PY, Gosset D, Fruchart JC, Devulder B. Serum amyloid A concentrations in giant-cell arteritis and polymyalgia rheumatica: a useful test in the management of the disease. Clin Exp Rheumatol. 1991 Mar-Apr;9(2):157-63. — View Citation
Kermani TA, Schmidt J, Crowson CS, Ytterberg SR, Hunder GG, Matteson EL, Warrington KJ. Utility of erythrocyte sedimentation rate and C-reactive protein for the diagnosis of giant cell arteritis. Semin Arthritis Rheum. 2012 Jun;41(6):866-71. doi: 10.1016/j.semarthrit.2011.10.005. Epub 2011 Nov 25. — View Citation
Kieffer P, Hinschberger O, Ciobanu E, Jaeger-Bizet F, Drabo A, Mostoufizadeh T, Martzolff L. [Clinical and biological efficacy of tocilizumab in giant cell arteritis: report of three patients and literature review]. Rev Med Interne. 2014 Jan;35(1):56-9. doi: 10.1016/j.revmed.2012.12.012. Epub 2013 Sep 26. Review. French. — View Citation
Kyle V, Cawston TE, Hazleman BL. Erythrocyte sedimentation rate and C reactive protein in the assessment of polymyalgia rheumatica/giant cell arteritis on presentation and during follow up. Ann Rheum Dis. 1989 Aug;48(8):667-71. — View Citation
Lachmann HJ, Goodman HJ, Gilbertson JA, Gallimore JR, Sabin CA, Gillmore JD, Hawkins PN. Natural history and outcome in systemic AA amyloidosis. N Engl J Med. 2007 Jun 7;356(23):2361-71. — View Citation
Laria A, Zoli A, Bocci M, Castri F, Federico F, Ferraccioli GF. Systematic review of the literature and a case report informing biopsy-proven giant cell arteritis (GCA) with normal C-reactive protein. Clin Rheumatol. 2012 Sep;31(9):1389-93. doi: 10.1007/s10067-012-2031-3. Epub 2012 Jul 22. Review. — View Citation
Ly KH, Liozon E, Fauchais AL, Vidal E. [Pathophysiology of giant cell arteritis]. Rev Med Interne. 2013 Jul;34(7):392-402. doi: 10.1016/j.revmed.2013.02.037. Epub 2013 Mar 23. Review. French. — View Citation
Ly KH, Régent A, Tamby MC, Mouthon L. Pathogenesis of giant cell arteritis: More than just an inflammatory condition? Autoimmun Rev. 2010 Aug;9(10):635-45. doi: 10.1016/j.autrev.2010.05.002. Epub 2010 May 8. Review. — View Citation
Ma-Krupa W, Jeon MS, Spoerl S, Tedder TF, Goronzy JJ, Weyand CM. Activation of arterial wall dendritic cells and breakdown of self-tolerance in giant cell arteritis. J Exp Med. 2004 Jan 19;199(2):173-83. — View Citation
Maffioli L, Mazzone A. Giant-cell arteritis and polymyalgia rheumatica. N Engl J Med. 2014 Oct 23;371(17):1652-3. doi: 10.1056/NEJMc1409206. — View Citation
Martinez-Taboada VM, Alvarez L, RuizSoto M, Marin-Vidalled MJ, Lopez-Hoyos M. Giant cell arteritis and polymyalgia rheumatica: role of cytokines in the pathogenesis and implications for treatment. Cytokine. 2008 Nov;44(2):207-20. doi: 10.1016/j.cyto.2008.09.004. Epub 2008 Nov 4. Review. — View Citation
Proven A, Gabriel SE, Orces C, O'Fallon WM, Hunder GG. Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes. Arthritis Rheum. 2003 Oct 15;49(5):703-8. — View Citation
Salvarani C, Magnani L, Catanoso M, Pipitone N, Versari A, Dardani L, Pulsatelli L, Meliconi R, Boiardi L. Tocilizumab: a novel therapy for patients with large-vessel vasculitis. Rheumatology (Oxford). 2012 Jan;51(1):151-6. doi: 10.1093/rheumatology/ker296. Epub 2011 Nov 10. — View Citation
Samson M, Audia S, Fraszczak J, Trad M, Ornetti P, Lakomy D, Ciudad M, Leguy V, Berthier S, Vinit J, Manckoundia P, Maillefert JF, Besancenot JF, Aho-Glele S, Olsson NO, Lorcerie B, Guillevin L, Mouthon L, Saas P, Bateman A, Martin L, Janikashvili N, Larmonier N, Bonnotte B. Th1 and Th17 lymphocytes expressing CD161 are implicated in giant cell arteritis and polymyalgia rheumatica pathogenesis. Arthritis Rheum. 2012 Nov;64(11):3788-98. doi: 10.1002/art.34647. — View Citation
Samson M, Audia S, Martin L, Janikashvili N, Bonnotte B. Pathogenesis of giant cell arteritis: new insight into the implication of CD161+ T cells. Clin Exp Rheumatol. 2013 Jan-Feb;31(1 Suppl 75):S65-73. Epub 2013 Apr 19. Review. — View Citation
Samson M, Bonnotte B. [Giant-cell arteritis pathogenesis]. Presse Med. 2012 Oct;41(10):937-47. doi: 10.1016/j.lpm.2012.07.005. Epub 2012 Aug 14. Review. French. — View Citation
Unizony S, Arias-Urdaneta L, Miloslavsky E, Arvikar S, Khosroshahi A, Keroack B, Stone JR, Stone JH. Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1720-9. doi: 10.1002/acr.21750. — View Citation
Visvanathan S, Rahman MU, Hoffman GS, Xu S, García-Martínez A, Segarra M, Lozano E, Espígol-Frigolé G, Hernández-Rodríguez J, Cid MC. Tissue and serum markers of inflammation during the follow-up of patients with giant-cell arteritis--a prospective longitudinal study. Rheumatology (Oxford). 2011 Nov;50(11):2061-70. doi: 10.1093/rheumatology/ker163. Epub 2011 Aug 25. — View Citation
Weyand CM, Younge BR, Goronzy JJ. IFN-? and IL-17: the two faces of T-cell pathology in giant cell arteritis. Curr Opin Rheumatol. 2011 Jan;23(1):43-9. doi: 10.1097/BOR.0b013e32833ee946. Review. — View Citation
Yoeruek E, Szurman P, Tatar O, Weckerle P, Wilhelm H. Anterior ischemic optic neuropathy due to giant cell arteritis with normal inflammatory markers. Graefes Arch Clin Exp Ophthalmol. 2008 Jun;246(6):913-5. doi: 10.1007/s00417-007-0762-7. Epub 2008 Apr 2. — View Citation
* Note: There are 25 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Biomarkers's serum sampling | For dosage of biomarkers in serum, like serum amyloid A or interleukins. | 3 minutes |