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

• ClinicalTrials.gov Identifier: NCT01400464
• Recruitment Status: Unknown
• First Posted: July 22, 2011
• Last Update Posted: April 9, 2014
• Sponsor: University Hospital, Caen
• Information provided by (Responsible Party): University Hospital, Caen

Tracking Information

• First Submitted Date: July 21, 2011
• First Posted Date: July 22, 2011
• Last Update Posted Date: April 9, 2014
• Study Start Date: July 2009
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 21, 2011): oral clearance of prednisolone [ Time Frame: 2 to 4 weeks after begining prednisolone treatment ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
• Official Title: Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Giant Cell Arteritis

Intervention

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.

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 21, 2011): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2014
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

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:

  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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01400464
• Other Study ID Numbers: 2008-004896-23
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Caen
• Original Responsible Party: Monsieur Angel Piquemal, Caen University Hospital
• Current Study Sponsor: University Hospital, Caen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Hospital, Caen
• Verification Date: April 2014