PREDNISONE for Giant cell arteritis (Horton's disease)

Inclusion criteria

• {"criterion_text":"-\tPatients over 50 years old"}
• {"criterion_text":"-\tDiagnosis of ACG based on the presence of two of the 4 ACR 1990 bio-clinical criteria (i.e. age > 50 years and unusual headache and/or tenderness in the temporal artery pathway and/or biological inflammatory syndrome (defined as c-reactive protein >5 mg/l or sedimentation rate >50 mm at first hour) and the mandatory presence of one of the following 3 criteria:  positivity of a temporal artery biopsy or  evidence of large-vessel vasculitis (on aortic angioscan, positron emission tomography or MRI angiography) or  positivity of a temporal artery echo-Doppler performed by a recognized, experienced physician (radiologist or vascular physician)."}
• {"criterion_text":"-\tOral corticosteroid therapy started no more than 14 days ago, excluding boluses"}
• {"criterion_text":"-\tPatient registered with the social security system"}
• {"criterion_text":"-\tPatient who has given written consent"}

Exclusion criteria

• {"criterion_text":"-\tOral corticosteroid therapy started more than 14 days ago, excluding bolus therapy"}
• {"criterion_text":"- Persons under court protection, guardianship or curatorship"}
• {"criterion_text":"Hypersensitivity to prednisone"}
• {"criterion_text":"-\tAny infectious condition requiring systemic treatment"}
• {"criterion_text":"- Evolving viruses (including hepatitis, herpes, chickenpox, shingles)"}
• {"criterion_text":"Patient on immunosuppressive therapy at inclusion"}
• {"criterion_text":"- Psychotic states not yet controlled by treatment"}
• {"criterion_text":"- Immunization with a live vaccine within 8 weeks of starting treatment"}
• {"criterion_text":"- Pregnant women (for non-menopausal women, negative high-sensitivity pregnancy test)"}
• {"criterion_text":"- Women of childbearing age without effective contraception"}
• {"criterion_text":"•\tGiant cell arteritis in relapse"}
• {"criterion_text":"•\tPersistent severe dementia"}
• {"criterion_text":"•\tNon-observant patient"}
• {"criterion_text":"•\tPatient living more than 150 km from the investigating center"}

Primary endpoints

• {"endpoint_text":"- In each of the two arms (28- and 52-week regimens): number of patients in complete remission without relapse at S52, based on total number of patients included","definition_or_measurement_approach":"Assessment at week 52 (S52); number of patients in complete remission without relapse reported relative to total number of patients included."}

Secondary endpoints

• {"endpoint_text":"- Measurement of the number of 1st relapses at S28 and S52 / number of patients included - Measurement of the number of 2nd relapses at S28 and S52 / number of patients included","definition_or_measurement_approach":"Count of first and second relapses at weeks 28 and 52, reported relative to number of patients included."}
• {"endpoint_text":"- Measurement of extremes, means and medians of time to 1st and 2nd relapses","definition_or_measurement_approach":"Statistical summary (extremes, mean, median) of time-to-event for first and second relapses."}
• {"endpoint_text":"- Measurement of extremes, means, and medians of durations and individual cumulative doses of cortisone relative to body weights at S28 and S52","definition_or_measurement_approach":"Statistical summaries (extremes, means, medians) of treatment durations and cumulative cortisone doses normalized to body weight at weeks 28 and 52."}
• {"endpoint_text":"- Measuring the number of patients with cortico-dependent disease at S52","definition_or_measurement_approach":"Count of patients meeting definition of corticosteroid-dependent disease at week 52 (definition provided in secondary objectives: inability to drop below 0.3 mg/kg at 6 months or 0.15 mg/kg at 12 months)."}
• {"endpoint_text":"- measurement of blood pressure, weight, glycemia, glycated hemoglobin, biochemistry, infectious complications, fracture complications, glaucoma, cataracts. Screening in both arms for the onset or decompensation of type 2 diabetes and any cardiovascular events. Bone densitometry (at baseline, S28 and S52) and adverse events attributable to corticosteroid therapy as soon as consent was signed and for the duration of the study.","definition_or_measurement_approach":"Clinical and laboratory monitoring (vitals, metabolic parameters, biochemistry), imaging (bone densitometry at baseline, S28, S52), and recording of adverse events attributable to corticosteroid therapy during study period."}

France

Earliest CTIS Part Ii Submission Date

16-10-2024

Latest Decision Or Authorization Date

24-07-2025

Processing Time Days

281

Number Of Sites

6

Number Of Participants

150

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Caen Normandie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France