Hydroxychloroquine in Giant Cell Arteritis

Giant Cell Arteritis Clinical Trial

Official title:

Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430807
• Other study ID #: 0102808
• Secondary ID: PHRC 2001
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2007
• Last updated: October 4, 2015
• Start date: January 2002
• Est. completion date: December 2006

Study information

• Verified date: October 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2006
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• hydroxychloroquine/placebo

Locations

Country	Name	City	State
France	Hospital	Agen
France	Hospital	Albi
France	Hospital Auch	Auch
France	Hospital Avignon	Avignon
France	University Hospital Besançon	Besançon
France	Hospital Béziers	Beziers
France	University Hospital Côte de Nacre	Caen
France	University Hospital Dijon	Dijon
France	Hospital	Foix
France	Hospital	Lavaur
France	University Hospital Dupuytren	Limoges
France	Hospital	Lisieux
France	Hospital	Lourdes
France	Hospital	Mazamet
France	Hospital	Montauban
France	University Hospital	Nantes
France	Saint Louis Hospital	Paris
France	University Hospital Bichat	Paris
France	University Hospital Saint Antoine	Paris
France	Hospital Suresnes	Suresnes
France	University Hospital	Toulouse
France	University Hospital Toulouse	Toulouse
France	University Hospital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View Citation

David-Chaussé 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. — View 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, Hernández-Rodríguez 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. — View Citation

Jover JA, Hernández-García C, Morado IC, Vargas E, Bañares A, Fernández-Gutiérrez 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. — View Citation

Le Guennec P, Dromer C, Sixou L, Marc V, Coustals P, Fournié 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. Review. French. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prednisone dosage equal to or lower than 5 mg since more than 3 months without		3 months at least	No
Primary	having experienced relapse since the inclusion in the study			No
Secondary	prednisone daily dosage		6, 12, 18 and 24 months	No
Secondary	hydroxychloroquine blood levels			No

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