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

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ClinicalTrials.gov Identifier: NCT01400464
Recruitment Status : Unknown
Verified April 2014 by University Hospital, Caen.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2011
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: Prednisone therapy and pharmacokinetic Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
Study Start Date : July 2009
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arms and Interventions
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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.

Outcome Measures
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Primary Outcome Measures :
  1. oral clearance of prednisolone [ Time Frame: 2 to 4 weeks after begining prednisolone treatment ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400464


Locations
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France
CHU de CAEN
Caen, Etat, France, 14000
Hôpital Cochin-APHP
Paris, Etat, France, 75679
Centre Hospitalier Universitaire de Toulouse
Toulouse, Etat, France, 31000
CH de Valenciennes
Valenciennes, Etat, France, 59300
CHU Avicennes
Bobigny, France, 93000
CHU Jean Verdier (AP-HP)
Bondy, France, 93140
Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63000
CHU de Lille
Lille, France, 59000
Centre Hospitalier Universitaire de Limoges
Limoges, France, 87000
CHU de Nantes
Nantes, France, 44000
Hôpital Pitié-Salpêtrière-APHP
Paris, France, 75651
CHU de Rouen
Rouen, France, 76000
Sponsors and Collaborators
University Hospital, Caen
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01400464    
Other Study ID Numbers: 2008-004896-23
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by University Hospital, Caen:
Giant Cell Arteritis
prednisone
pharmacokinetics
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
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
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents