RANDOMIZED, CONTROLLED, OPEN TRIAL OF TWO STANDARDIZED DECLINE SCHEMES, FAST (NORTH AMERICAN) AND SLOW (EUROPEAN) RESPECTIVELY, OF CORTISONE IN GIANT CELL ARTERITIS

Conditions

Patients with giant cell arteritis (= Horton’s disease)

Brief summary

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

Detailed description

- 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, - Measurement of extremes, means and medians of time to 1st and 2nd relapses, - Measurement of extremes, means, and medians of durations and individual cumulative doses of cortisone relative to body weights at S28 and S52, - Measuring the number of patients with cortico-dependent disease at S52, 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.

Related papers

No related papers found yet.

Interventions

DRUGPREDNISONE VIATRIS 5 mg

DRUGcomprimé sécable

DRUGPREDNISONE VIATRIS 20 mg

DRUGPREDNISONE VIATRIS 1 mg

DRUGcomprimé

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
- 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, - Measurement of extremes, means and medians of time to 1st and 2nd relapses, - Measurement of extremes, means, and medians of durations and individual cumulative doses of cortisone relative to body weights at S28 and S52, - Measuring the number of patients with cortico-dependent disease at S52, 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.	—

Measure

Time frame

- 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, - Measurement of extremes, means and medians of time to 1st and 2nd relapses, - Measurement of extremes, means, and medians of durations and individual cumulative doses of cortisone relative to body weights at S28 and S52, - Measuring the number of patients with cortico-dependent disease at S52, 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.

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Countries

France

Outcome results

None listed