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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01400464
First received: July 21, 2011
Last updated: April 8, 2014
Last verified: April 2014
  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 2014
Estimated Primary Completion Date: September 2014 (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:

    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01400464     History of Changes
Other Study ID Numbers: 2008-004896-23
Study First Received: July 21, 2011
Last Updated: April 8, 2014
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:
Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014