Hydroxychloroquine in Giant Cell Arteritis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Giant Cell Arteritis	Drug: hydroxychloroquine/placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.

Resource links provided by NLM:

MedlinePlus related topics: Giant Cell Arteritis Polymyalgia Rheumatica Steroids

Drug Information available for: Hydroxychloroquine Hydroxychloroquine sulfate

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:

prednisone dosage equal to or lower than 5 mg since more than 3 months without
having experienced relapse since the inclusion in the study

Secondary Outcome Measures:

prednisone dialy dosage at 6, 12, 18 and 24 months, hydroxychloroquine blood levels, number of relapses during follow-up, influence of HLA genotype on outcome.

Enrollment:	75
Study Start Date:	January 2002
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430807

Locations

France
Hospital
Agen, France, 47923
Hospital
Albi, France, 81000
Hospital Auch
Auch, France, 32008
Hospital Avignon
Avignon, France, 84902
University Hospital Besançon
Besançon, France, 25030
Hospital Béziers
Beziers, France, 34525
University Hospital Côte de Nacre
Caen, France, 14033
University Hospital Dijon
Dijon, France, 21035
Hospital
Foix, France, 09017
Hospital
Lavaur, France, 81500
University Hospital Dupuytren
Limoges, France, 87042
Hospital
Lisieux, France, 14100
Hospital
Lourdes, France, 65107
Hospital
Mazamet, France, 81200
Hospital
Montauban, France, 82013
University Hospital
Nantes, France, 44035
Saint Louis Hospital
Paris, France, 75010
University Hospital Saint Antoine
Paris, France, 75012
University Hospital Bichat
Paris, France, 75018
Hospital Suresnes
Suresnes, France, 92151
University Hospital
Toulouse, France, 31059
University Hospital Toulouse
Toulouse, France, 31059
University Hospital Bretonneau
Tours, France, 37044

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator:	ARLET Philippe, D	CHU Toulouse, Hôpital Purpan
Study Director:	SAILLER Laurent, MD	CHU Toulouse, Service de Médecine Interne, Hôpital Purpan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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. Review. 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.

ClinicalTrials.gov Identifier:	NCT00430807 History of Changes
Other Study ID Numbers:	0102808, PHRC 2001
Study First Received:	January 31, 2007
Last Updated:	July 23, 2009
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:

giant cell arteritis,
hydroxychloroquine,
corticosteroid sparing,
corticodependence

Additional relevant MeSH terms:

Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases

Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Hydroxychloroquine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 21, 2013