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

Giant Cell Arteritis Clinical Trial

— PREDICORT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01400464
• Other study ID #: 2008-004896-23
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 21, 2011
• Last updated: April 8, 2014
• Start date: July 2009
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

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.

Locations

Country	Name	City	State
France	CHU Avicennes	Bobigny
France	CHU Jean Verdier (AP-HP)	Bondy
France	CHU de CAEN	Caen	Etat
France	Hôpital Gabriel Montpied	Clermont-Ferrand
France	CHU de Lille	Lille
France	Centre Hospitalier Universitaire de Limoges	Limoges
France	CHU de Nantes	Nantes
France	Hôpital Cochin-APHP	Paris	Etat
France	Hôpital Pitié-Salpêtrière-APHP	Paris
France	CHU de Rouen	Rouen
France	Centre Hospitalier Universitaire de Toulouse	Toulouse	Etat
France	CH de Valenciennes	Valenciennes	Etat

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral clearance of prednisolone		2 to 4 weeks after begining prednisolone treatment	No