- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400464
Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis (PREDICORT)
April 8, 2014 updated by: University Hospital, Caen
Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
The factors underlying the large interindividual variability in response to glucocorticoids in Giant Cell Arteritis are poorly understood.
The investigators hypothesize that a part of this variability is related to pharmacokinetic factors determined by genetic polymorphism: hepatic clearance involving cytochromes P450 of the subfamily 3A (CYP3A) and drug efflux leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs (ABCB1).
The investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic cohort study to assess the link between prednisolone clearance and the relapse risk in giant cell arteritis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bobigny, France, 93000
- CHU Avicennes
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Bondy, France, 93140
- CHU Jean Verdier (AP-HP)
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Clermont-Ferrand, France, 63000
- Hôpital Gabriel Montpied
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Lille, France, 59000
- CHU de Lille
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Limoges, France, 87000
- Centre Hospitalier Universitaire de Limoges
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Nantes, France, 44000
- CHU de Nantes
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Paris, France, 75651
- Hôpital Pitié-Salpêtrière-APHP
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Rouen, France, 76000
- CHU de Rouen
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Etat
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Caen, Etat, France, 14000
- CHU de Caen
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Paris, Etat, France, 75679
- Hôpital Cochin-APHP
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Toulouse, Etat, France, 31000
- Centre Hospitalier Universitaire de Toulouse
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Valenciennes, Etat, France, 59300
- CH de Valenciennes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:
- At least 50 years of age at disease onset
- New onset or new type of localized pain in the head
- Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries)
- ESR of greater than 40 mm in the first hour by the Westergren method
- Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells
- Corticoid treatment since less than 14 days
- Signed informed consent
- Affiliation to the social security system
Exclusion Criteria:
- Dementia
- Predictable non observance
- Neoplasia since less than 5 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
oral clearance of prednisolone
Time Frame: 2 to 4 weeks after begining prednisolone treatment
|
2 to 4 weeks after begining prednisolone treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Anticipated)
September 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
July 21, 2011
First Submitted That Met QC Criteria
July 21, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Estimate)
April 9, 2014
Last Update Submitted That Met QC Criteria
April 8, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Vasculitis
- Skin Diseases, Vascular
- Vasculitis, Central Nervous System
- Polymyalgia Rheumatica
- Giant Cell Arteritis
- Arteritis
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- 2008-004896-23
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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