Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
PREDICORT
Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
1 other identifier
interventional
150
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2009
Longer than P75 for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 9, 2014
April 1, 2014
5.2 years
July 21, 2011
April 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
oral clearance of prednisolone
2 to 4 weeks after begining prednisolone treatment
Interventions
Prednisone therapy delivered in accordance with a 10 to 18 month pre-defined schedule. Pharmacokinetic and pharmacogenetic tests at 14 or 28 days. Monthly visit for the first 6 month, then every 8 weeks months thereafter for the remainder of the study with standard biologic monitoring , physical exam and medical and medication history .Also, participants will be asked to complete several questionnaires to assess quality of life and observance to therapy. Participants may have additional study visits if a disease flare or disease-related complications occur during the study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Dementia
- Predictable non observance
- Neoplasia since less than 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
CHU de CAEN
Caen, Etat, 14000, France
Hôpital Cochin-APHP
Paris, Etat, 75679, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, Etat, 31000, France
CH de Valenciennes
Valenciennes, Etat, 59300, France
CHU Avicennes
Bobigny, 93000, France
CHU Jean Verdier (AP-HP)
Bondy, 93140, France
Hôpital Gabriel Montpied
Clermont-Ferrand, 63000, France
CHU de Lille
Lille, 59000, France
Centre Hospitalier Universitaire de Limoges
Limoges, 87000, France
CHU de Nantes
Nantes, 44000, France
Hôpital Pitié-Salpêtrière-APHP
Paris, 75651, France
CHU de Rouen
Rouen, 76000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 22, 2011
Study Start
July 1, 2009
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
April 9, 2014
Record last verified: 2014-04