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:
University Hospital, Caen
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01400464
First received: July 21, 2011
Last updated: March 13, 2012
Last verified: March 2012
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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:
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:
-
Drug: Prednisone therapy and pharmacokinetic
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:
- 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
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 16, 2013