Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2002-01-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Interventions
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hydroxychloroquine/placebo
Eligibility Criteria
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Inclusion Criteria
* corticosteroid treatment since less than 1 month
* age less than 85 years
* signed informed consent
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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ARLET Philippe, D
Role: PRINCIPAL_INVESTIGATOR
CHU Toulouse, Hôpital Purpan
SAILLER Laurent, MD
Role: STUDY_DIRECTOR
CHU Toulouse, Service de Médecine Interne, Hôpital Purpan
Locations
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Hospital
Agen, , France
Hospital
Albi, , France
Hospital Auch
Auch, , France
Hospital Avignon
Avignon, , France
University Hospital Besançon
Besançon, , France
Hospital Béziers
Béziers, , 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 Saint Antoine
Paris, , France
University Hospital Bichat
Paris, , France
Hospital Suresnes
Suresnes, , France
University Hospital Toulouse
Toulouse, , France
University Hospital
Toulouse, , France
University Hospital Bretonneau
Tours, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Related Info
Related Info
Other Identifiers
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PHRC 2001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0102808
Identifier Type: -
Identifier Source: org_study_id
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