Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis (PREDICORT)

This study is currently recruiting participants.

Verified March 2012 by University Hospital, Caen

Sponsor:

Information provided by:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT01400464

First received: July 21, 2011

Last updated: March 13, 2012

Last verified: March 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Giant Cell Arteritis	Drug: Prednisone therapy and pharmacokinetic	Phase 4

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis

Resource links provided by NLM:

MedlinePlus related topics: Giant Cell Arteritis Polymyalgia Rheumatica Steroids

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:

oral clearance of prednisolone [ Time Frame: 2 to 4 weeks after begining prednisolone treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:
1. At least 50 years of age at disease onset
2. New onset or new type of localized pain in the head
3. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries)
4. ESR of greater than 40 mm in the first hour by the Westergren method
5. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400464

Locations

France
CHU de CAEN	Recruiting
Caen, Etat, France, 14000
Contact: Boris BIENVENU, MD, PhD 0231064584 bienvenu-b@chu-caen.fr
Principal Investigator: Boris BIENVENU, MD,PhD
Sub-Investigator: Jonathan BOUTEMY, CCA
Sub-Investigator: Yann OLLIVIER, PH
Sub-Investigator: Gwénola MAIGNE, PH
Hôpital Cochin-APHP	Recruiting
Paris, Etat, France, 75679
Contact: Loïc GUILLEVIN, PU-PH 01 58 41 13 21 loic.guillevin@cch.aphp.fr
Principal Investigator: Loïc GUILLEVIN, PU-PH
Centre Hospitalier Universitaire de Toulouse	Recruiting
Toulouse, Etat, France, 31000
Contact: Laurent SAILLER, PU-PH 05 61 77 96 78 sailler.l@chu-toulouse.fr
Principal Investigator: Laurent SAILLER, PU-PH
CH de Valenciennes	Recruiting
Valenciennes, Etat, France, 59300
Contact: Xavier KYNDT, PH 03 27 14 50 77 kyndt-x@ch-valenciennes.fr
Contact: Thomas QUEMENEUR, PH 03 27 14 50 77 quemeneur-t@ch-valenciennes.fr
Principal Investigator: Xavier KYNDT, PH
Sub-Investigator: Thomas QUEMENEUR, PH
CHU Avicennes	Recruiting
Bobigny, France, 93000
Contact: Claire LARROCHE, PH 01 48 95 54 57 claire.larroche@avc.aphp.fr
Principal Investigator: Claire LARROCHE, PH
CHU Jean Verdier (AP-HP)	Recruiting
Bondy, France, 93140
Contact: Olivier FAIN, PU-PH 01 48 02 66 75 olivier.fain@jvr.aphp.fr
Principal Investigator: Oliver FAIN, PU-PH
Sub-Investigator: Arsène MEKINIAN, PH
Hôpital Gabriel Montpied	Recruiting
Clermont-Ferrand, France, 63000
Contact: Marc ANDRE 04 73 75 14 35 mandre@chu-clermontferrand.fr
Principal Investigator: Marc ANDRE, PU-PH
Sub-Investigator: Gaëlle GUETTROT-IMBERT, PH
CHU de Lille	Recruiting
Lille, France, 59000
Contact: Eric HACHULLA, PU-PH 03 20 44 50 48 ehachulla@chru-lille.fr
Principal Investigator: Eric HACHULLA, PU-PH
Sub-Investigator: Marc LAMBERT, PH
Centre Hospitalier Universitaire de Limoges	Recruiting
Limoges, France, 87000
Contact: Eric LIOZON, PH 05 55 05 65 03 eric.liozon@chu-limoges.fr
Principal Investigator: Eric LIOZON, PH
Sub-Investigator: Elisabeth VIDAL, PU-PH
CHU de Nantes	Recruiting
Nantes, France, 44000
Contact: Mohamed HAMIDOU, PU-PH 02 40 08 33 41 mohamed.hamidou@chu-nantes.fr
Principal Investigator: Mohamed HAMIDOU, PU-PH
Hôpital Pitié-Salpêtrière-APHP	Recruiting
Paris, France, 75651
Contact: Jacques BODDAERT, PH 01 42 16 41 17 jacques.boddaert@psl.aphp.fr
Principal Investigator: Jacques BODDAERT, PH
Sub-Investigator: Nathalie COSTEDOAT-CHALUMEAU, PH
Sub-Investigator: Nathalie MOREL, PH
Sub-Investigator: Yves ALLENBACH, CCA
CHU de Rouen	Recruiting
Rouen, France, 76000
Contact: Isabelle MARIE, PU-PH 02 32 88 90 03 isabelle.marie@chu-rouen.fr
Principal Investigator: Isabelle MARIE, PU-PH

Sponsors and Collaborators

University Hospital, Caen

More Information

No publications provided

Responsible Party:	Monsieur Angel Piquemal, Caen University Hospital
ClinicalTrials.gov Identifier:	NCT01400464 History of Changes
Other Study ID Numbers:	2008-004896-23
Study First Received:	July 21, 2011
Last Updated:	March 13, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:

Giant Cell Arteritis
prednisone
pharmacokinetics

Additional relevant MeSH terms:

Giant Cell Arteritis
Polymyalgia Rheumatica
Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases

Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013

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