Clinical trial NCT00430807: Hydroxychloroquine in Giant Cell Arteritis
Official title: Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Giant Cell Arteritis
Keywords: giant cell arteritis,
hydroxychloroquine,
corticosteroid sparing,
corticodependence
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2007-02-02
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. We have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.


Eligibility criteria: Inclusion Criteria:

* giant celle arteritis with at least 3 ACR criteria including a disgnostic temporal artery biopsy
* corticosteroid treatment since less than 1 month
* age less than 85 years
* signed informed consent

Exclusion Criteria:

* amaurosis fugax, loss of vision, acute lumb ischemia, angina pectoris or myocardium infarctus, mesenteric ischemia or other vascular complications related to GCA
* low life expectancy (\<2 years)
* corticosteroid treatment since more than 30 days whatever the dosage
* primary corticosteroid resistance defined by persistant symptoms despite prednisone for more than 15 days
* previous psychiatric troubles induced corticosteroids
* hydroxychloroquine contra-indicated

Primary outcomes:
measure: prednisone dosage equal to or lower than 5 mg since more than 3 months without
timeFrame: 3 months at least
measure: having experienced relapse since the inclusion in the study
Secondary outcomes:
measure: prednisone daily dosage
timeFrame: 6, 12, 18 and 24 months
measure: hydroxychloroquine blood levels
Other outcomes:
Locations:
city: Agen
country: France
facility: Hospital
city: Albi
country: France
facility: Hospital
city: Auch
country: France
facility: Hospital Auch
city: Avignon
country: France
facility: Hospital Avignon
city: Besançon
country: France
facility: University Hospital Besançon
city: Beziers
country: France
facility: Hospital Béziers
city: Caen
country: France
facility: University Hospital Côte de Nacre
city: Dijon
country: France
facility: University Hospital Dijon
city: Foix
country: France
facility: Hospital
city: Lavaur
country: France
facility: Hospital
city: Limoges
country: France
facility: University Hospital Dupuytren
city: Lisieux
country: France
facility: Hospital
city: Lourdes
country: France
facility: Hospital
city: Mazamet
country: France
facility: Hospital
city: Montauban
country: France
facility: Hospital
city: Nantes
country: France
facility: University Hospital
city: Paris
country: France
facility: Saint Louis Hospital
city: Paris
country: France
facility: University Hospital Saint Antoine
city: Paris
country: France
facility: University Hospital Bichat
city: Suresnes
country: France
facility: Hospital Suresnes
city: Toulouse
country: France
facility: University Hospital Toulouse
city: Toulouse
country: France
facility: University Hospital
city: Tours
country: France
facility: University Hospital Bretonneau
Study officials:
affiliation: CHU Toulouse, Hôpital Purpan
name: ARLET Philippe, D
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Toulouse, Service de Médecine Interne, Hôpital Purpan
name: SAILLER Laurent, MD
role: STUDY_DIRECTOR
References:
citation: Jover JA, Hernandez-Garcia C, Morado IC, Vargas E, Banares A, Fernandez-Gutierrez B. Combined treatment of giant-cell arteritis with methotrexate and prednisone. a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Jan 16;134(2):106-14. doi: 10.7326/0003-4819-134-2-200101160-00010.
citation: Chevalet P, Barrier JH, Pottier P, Magadur-Joly G, Pottier MA, Hamidou M, Planchon B, El Kouri D, Connan L, Dupond JL, De Wazieres B, Dien G, Duhamel E, Grosbois B, Jego P, Le Strat A, Capdeville J, Letellier P, Agron L. A randomized, multicenter, controlled trial using intravenous pulses of methylprednisolone in the initial treatment of simple forms of giant cell arteritis: a one year followup study of 164 patients. J Rheumatol. 2000 Jun;27(6):1484-91.
citation: Mazlumzadeh M, Hunder GG, Easley KA, Calamia KT, Matteson EL, Griffing WL, Younge BR, Weyand CM, Goronzy JJ. Treatment of giant cell arteritis using induction therapy with high-dose glucocorticoids: a double-blind, placebo-controlled, randomized prospective clinical trial. Arthritis Rheum. 2006 Oct;54(10):3310-8. doi: 10.1002/art.22163.
citation: Le Guennec P, Dromer C, Sixou L, Marc V, Coustals P, Fournie B. [Treatment of Horton disease. Value of synthetic antimalarials. Apropos of a retrospective study of 36 patients]. Rev Rhum Ed Fr. 1994;61(7-8):485-90. French.
citation: David-Chausse J, Dehais J, Leman A. [Results of a regional survey on the treatment of rhizomelic pseudopolyarthritis and temporal arteritis. Apropos of 242 cases treated by various modalities with synthetic antimalarials, corticoids and non-steroidal anti-inflammatory agents]. Rev Rhum Mal Osteoartic. 1983 Jul-Sep;50(8-9):563-71. French.
citation: Hoffman GS, Cid MC, Hellmann DB, Guillevin L, Stone JH, Schousboe J, Cohen P, Calabrese LH, Dickler H, Merkel PA, Fortin P, Flynn JA, Locker GA, Easley KA, Schned E, Hunder GG, Sneller MC, Tuggle C, Swanson H, Hernandez-Rodriguez J, Lopez-Soto A, Bork D, Hoffman DB, Kalunian K, Klashman D, Wilke WS, Scheetz RJ, Mandell BF, Fessler BJ, Kosmorsky G, Prayson R, Luqmani RA, Nuki G, McRorie E, Sherrer Y, Baca S, Walsh B, Ferland D, Soubrier M, Choi HK, Gross W, Segal AM, Ludivico C, Puechal X; International Network for the Study of Systemic Vasculitides. A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum. 2002 May;46(5):1309-18. doi: 10.1002/art.10262.