Monitoring adverse events of low-dose glucocorticoid therapy: EULAR recommendations for clinical trials and daily practice.
M C van der Goes, J W G Jacobs, M Boers...
https://pubmed.ncbi.nlm.nih.gov/20693273/Actively Recruiting
Led by University Hospital, Caen · Updated on 2026-06-26
150
Participants Needed
1
Research Sites
52 weeks
Total Duration
Giant cell arteritis GCA is a condition mainly affecting elderly people, often over 80 years old, and is usually treated with corticosteroids. Although corticosteroids initially work well, relapses are common when the dose is reduced. The study compares two corticosteroid tapering schedules a shorter North American style and a longer European style, to see if the shorter treatment is as good at preventing relapse while reducing side effects. This comparison is important as corticosteroid use over time can cause serious side effects like metabolic, muscle, infectious, and neuropsychiatric problems. Participants will be randomly assigned to one of two groups. One group will follow a corticosteroid tapering schedule over 28 weeks, and the other over 52 weeks. The starting corticosteroid dose and tapering amounts are adjusted based on body weight. The study looks at patients newly diagnosed with GCA, giving them treatment based on one of these two standardized regimens. An interim analysis will be done at week 28. During the study, participants will be monitored up to 52 weeks to assess whether they remain in complete remission without relapse. Researchers will measure relapse rates, cumulative corticosteroid doses, and treatment-related side effects. Safety evaluations will be conducted following established criteria. The findings may influence future treatment practices by balancing effectiveness and side effect reduction.
CONDITIONS
Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering
H
Hubert De BOYSSON, MD
A
Audrey SULTAN, PhD
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University Hospital, Caen
Lead Sponsor
University Hospital, Lille
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 or 52 weeks
Participants follow one of two corticosteroid tapering schedules: a short 28-week taper or a longer 52-week taper. Doses are adjusted based on body weight.
Duration - Up to 52 weeks
Participants are monitored up to 52 weeks to assess remission without relapse, relapse rates, corticosteroid doses, and side effects.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/14558057/Hubert de Boysson, Achille Aouba
https://pubmed.ncbi.nlm.nih.gov/28324917/University Hospital, Caen
Lead Sponsor
University Hospital, Lille
Collaborating Sponsor