Hydroxychloroquine in Giant Cell Arteritis

• ClinicalTrials.gov Identifier: NCT00430807
• Recruitment Status: Completed
• First Posted: February 2, 2007
• Last Update Posted: October 6, 2015
• Sponsor: University Hospital, Toulouse
• Information provided by (Responsible Party): University Hospital, Toulouse

Tracking Information

• First Submitted Date: January 31, 2007
• First Posted Date: February 2, 2007
• Last Update Posted Date: October 6, 2015
• Study Start Date: January 2002
• Actual Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 4, 2015)

• prednisone dosage equal to or lower than 5 mg since more than 3 months without [ Time Frame: 3 months at least ]
• having experienced relapse since the inclusion in the study

Original Primary Outcome Measures (submitted: February 1, 2007)

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

Current Secondary Outcome Measures (submitted: October 4, 2015)

• prednisone daily dosage [ Time Frame: 6, 12, 18 and 24 months ]
• hydroxychloroquine blood levels

• Original Secondary Outcome Measures (submitted: February 1, 2007): 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.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Giant Cell Arteritis
• Intervention: Drug: hydroxychloroquine/placebo
• Study Arms: Not Provided

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. 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 29, 2007): 75
• Original Enrollment (submitted: February 1, 2007): 120
• Actual Study Completion Date: December 2006
• Actual Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00430807
• Other Study ID Numbers: 0102808; PHRC 2001 ( Other Grant/Funding Number: Ministry of Health )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Toulouse
• Original Responsible Party: Not Provided
• Current Study Sponsor: University Hospital, Toulouse
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital, Toulouse
• Verification Date: October 2015