Temporal Arteritis Clinical Trials

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A Randomized, Controled, Open Label Trial: Comparison Between Two Standardized Corticosteroids Tapering, Respectively Short (North American) and Long (European), in Giant Cell Arteritis

Who is this study for? Patients with Giant Cell Arteritis
What treatments are being studied? Corticosteroids for Systemic Use
Status: Not_yet_recruiting
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Corticosteroid therapy has always been the standard treatment for giant cell arteritis (GCA), with very good initial clinical efficacy but a high relapse rate when it declines. The target population of this condition, often elderly, is particularly exposed to the numerous undesirable effects of corticosteroid therapy, and this especially as its duration lengthens with the re-increases of doses according to relapses: metabolic complications, osteo-muscular , infectious or neuropsychiatric. Investigators propose to compare prospectively the results of a conventional corticosteroid regimen as recommended by European societies, to those of a lighter and / or shorter scheme, inspired by recent North American trials. , including the largest prospective global study in the field. Investigators hypothesize non-inferiority of the lightened regimen for relapse rate without relapse at S52, but with a decrease in treatment-related adverse events whose cumulative doses should be lower. Investigators therefore plan to include prospectively over 3 years 150 patients, 75 for each of the two arms, with a newly diagnosed ACG. A randomization of the treatment arm will be performed and a predefined pattern of cortisone adapted to body weight will be given to the patient. Relapse rates, maintenance of remission, cumulative doses of cortisone and adverse effects of treatment will be analyzed at the 52nd week of the introduction of corticosteroid therapy. An interim analysis is planned at S28.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Age ≥ 50 years

• Patient with temporal arteritis giant cell match 2 of the 4 criteria of the American College of Rheumatology (ACR) that given :

‣ a temporal artery biopsy compatible with a diagnosis of CAG or

⁃ an abdominal thoracic aortitis diagnosed by Angio CT, MR angiography or PET scanner or

⁃ Echo Doppler compatible with a diagnosis of CAG

• Oral corticosteroid treatment started up to 14 days, the initial dose is less or equal to 1 mg / Kg

• Patient wo has given its written consent Patient affiliated with a social security

Contact Information
Primary
Hubert De BOYSSON, MD
deboysson-h@chu-caen.fr
02 31 06 57 32
Backup
Audrey SULTAN, PhD
sultan-a@chu-caen.fr
02 31 06 33 58
Time Frame
Start Date: 2020-11-05
Completion Date: 2027-01
Participants
Target number of participants: 150
Treatments
Experimental: Short tapering corticosteroids
Corticosteroid taper over 28 weeks
Active_comparator: Long tapering corticosteroids
Corticosteroid taper over 52 weeks
Sponsors
Leads: University Hospital, Caen
Collaborators: Amiens University Hospital, University Hospital, Lille, Central Hospital Saint Quentin, University Hospital, Rouen, Central Hospital, Valenciennes, Central Hospital, Lisieux, University Hospital, Limoges

This content was sourced from clinicaltrials.gov