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

Primary Purpose

Giant Cell Arteritis

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Prednisone therapy and pharmacokinetic
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Giant Cell Arteritis focused on measuring Giant Cell Arteritis, prednisone, pharmacokinetics

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de CAEN
  • Hôpital Cochin-APHP
  • Centre Hospitalier Universitaire de Toulouse
  • CH de Valenciennes
  • CHU Avicennes
  • CHU Jean Verdier (AP-HP)
  • Hôpital Gabriel Montpied
  • CHU de Lille
  • Centre Hospitalier Universitaire de Limoges
  • CHU de Nantes
  • Hôpital Pitié-Salpêtrière-APHP
  • CHU de Rouen

Outcomes

Primary Outcome Measures

oral clearance of prednisolone

Secondary Outcome Measures

Full Information

First Posted
July 21, 2011
Last Updated
April 8, 2014
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT01400464
Brief Title
Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
Acronym
PREDICORT
Official Title
Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis
Keywords
Giant Cell Arteritis, prednisone, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Prednisone therapy and pharmacokinetic
Intervention Description
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.
Primary Outcome Measure Information:
Title
oral clearance of prednisolone
Time Frame
2 to 4 weeks after begining prednisolone treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de CAEN
City
Caen
State/Province
Etat
ZIP/Postal Code
14000
Country
France
Facility Name
Hôpital Cochin-APHP
City
Paris
State/Province
Etat
ZIP/Postal Code
75679
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse
City
Toulouse
State/Province
Etat
ZIP/Postal Code
31000
Country
France
Facility Name
CH de Valenciennes
City
Valenciennes
State/Province
Etat
ZIP/Postal Code
59300
Country
France
Facility Name
CHU Avicennes
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
CHU Jean Verdier (AP-HP)
City
Bondy
ZIP/Postal Code
93140
Country
France
Facility Name
Hôpital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Hospitalier Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hôpital Pitié-Salpêtrière-APHP
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

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

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