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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


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
See also
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Completed NCT03765424 - Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
Completed NCT03409913 - Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA N/A
Completed NCT01910038 - Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. Phase 2
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