Giant Cell ArteritisPhase 3NCT00430807
Hydroxychloroquine in Giant Cell Arteritis
A Phase 3 study of Giant Cell Arteritis, run by University Hospital, Toulouse at 23 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Giant Cell Arteritis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 23 sitesFrance
- Study dates
- Jan 2002to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
Hospital
Agen, 47923
Hospital
Albi, 81000
Hospital Auch
Auch, 32008
Hospital Avignon
Avignon, 84902
University Hospital Besançon
Besançon, 25030
Hospital Béziers
Béziers, 34525
University Hospital Côte de Nacre
Caen, 14033
University Hospital Dijon
Dijon, 21035
Hospital
Foix, 09017
Hospital
Lavaur, 81500
University Hospital Dupuytren
Limoges, 87042
Hospital
Lisieux, 14100
Hospital
Lourdes, 65107
Hospital
Mazamet, 81200
Hospital
Montauban, 82013
University Hospital
Nantes, 44035
Saint Louis Hospital
Paris, 75010
University Hospital Saint Antoine
Paris, 75012
University Hospital Bichat
Paris, 75018
Hospital Suresnes
Suresnes, 92151
University Hospital Toulouse
Toulouse, 31059
University Hospital
Toulouse, 31059
University Hospital Bretonneau
Tours, 37044
About this study
Official title: Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.
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.
- Conditions
- Giant Cell Arteritis
- Being tested
- hydroxychloroquine/placebo
- Keywords
- giant cell arteritis,, hydroxychloroquine,, corticosteroid sparing,, corticodependence
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxychloroquine/placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
prednisone dosage equal to or lower than 5 mg since more than 3 months without
Measured: 3 months at least
having experienced relapse since the inclusion in the study
Secondary outcomes (2)
prednisone daily dosage
Measured: 6, 12, 18 and 24 months
hydroxychloroquine blood levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startJan 2002
- Primary completionJan 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ARLET Philippe, D, Principal investigator, CHU Toulouse, Hôpital PurpanSAILLER Laurent, MD, Study director, CHU Toulouse, Service de Médecine Interne, Hôpital Purpan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430807
- Sponsor's protocol ID
- 0102808
- Other IDs
- PHRC 2001
- Status last verified
- Oct 2015
- First submitted
- 31 Jan 2007
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11177313Chevalet 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.
PubMed 10852275Mazlumzadeh 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.
PubMed 17009270Le 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.
PubMed 7833883David-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.
PubMed 6635510Hoffman 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.
PubMed 12115238
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.
- ClinicalTrials.gov ID
- NCT00430807
- Acronym / sponsor ID
- 0102808
- Conditions
- Giant Cell Arteritis
- Keywords
- giant cell arteritis,, hydroxychloroquine,, corticosteroid sparing,, corticodependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 2 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxychloroquine/placebo | Drug | – |
Primary outcome
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
2 secondary outcomes
prednisone daily dosage
Time frame: 6, 12, 18 and 24 months
hydroxychloroquine blood levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- Background: PubMed 11177313Jover 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.
- Background: PubMed 10852275Chevalet 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.
- Background: PubMed 17009270Mazlumzadeh 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.
- Background: PubMed 7833883Le 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.
- Background: PubMed 6635510David-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.
- Background: PubMed 12115238Hoffman 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 InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Giant Cell Arteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ARLET Philippe, D principal investigator
CHU Toulouse, Hôpital Purpan
SAILLER Laurent, MD study director
CHU Toulouse, Service de Médecine Interne, Hôpital Purpan
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Giant Cell Arteritis, run by University Hospital, Toulouse at 23 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prednisone dosage equal to or lower than 5 mg since more than 3 months without (time frame: 3 months at least). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00430807, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.