Hydroxychloroquine in Giant Cell Arteritis | NCT00430807

Studies
Hydroxychloroquine in Giant Cell Arteritis

NCT00430807

Sponsor

University Hospital, Toulouse

Status

Completed

Last Update Posted

Oct 6, 2015Estimated

Enrollment

75Actual

Phase

Phase 3

Conditions

Giant Cell Arteritis

Interventions

hydroxychloroquine/placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PHRC 2001	Other Grant/Funding Number	Ministry of Health

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Jan 2005Actual

Completion Date

Dec 2006Actual

First Submitted Date

Jan 31, 2007

First Submission Date that Met QC Criteria

Feb 1, 2007

First Posted Date

Feb 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2015

Last Update Posted Date

Oct 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Name	Type	Description	Arm Group Labels	Other Names
hydroxychloroquine/placebo	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
prednisone daily dosage		6, 12, 18 and 24 months
hydroxychloroquine blood levels

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital		Agen		47923	France
Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11177313	Background	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.
10852275	Background

ID	Term
D020293	Vasculitis, Central Nervous System
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D002561	Cerebrovascular Disorders

ID	Term
D002738	Chloroquine
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring