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RANDOMIZED, CONTROLLED, OPEN TRIAL OF TWO STANDARDIZED DECLINE SCHEMES, FAST (NORTH AMERICAN) AND SLOW (EUROPEAN) RESPECTIVELY, OF CORTISONE IN GIANT CELL ARTERITIS
EU CTIS ID: 2024-518653-41-00
What this study is testing
To compare in giant cell arteritis (GCA) the rate of complete remission without any relapse in the two arms of corticosteroid therapy (long regimen of 52 weeks versus short regimen of 28 weeks) at week 52 (W52). The working hypothesis is to verify the non-inferiority of the shortened American scheme, in comparison to the extended French and European scheme.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Patients over 50 years old
- • Diagnosis 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).
- • Oral corticosteroid therapy started no more than 14 days ago, excluding boluses
- • Patient registered with the social security system
- • Patient who has given written consent
You likely can't join if
- • Oral corticosteroid therapy started more than 14 days ago, excluding bolus therapy
- •Persons under court protection, guardianship or curatorship
- Hypersensitivity to prednisone
- • Any infectious condition requiring systemic treatment
- - Evolving viruses (including hepatitis, herpes, chickenpox, shingles)
- Patient on immunosuppressive therapy at inclusion
See the full eligibility criteria
- • Patients over 50 years old
- • Diagnosis 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).
- • Oral corticosteroid therapy started no more than 14 days ago, excluding boluses
- • Patient registered with the social security system
- • Patient who has given written consent
- • Oral corticosteroid therapy started more than 14 days ago, excluding bolus therapy
- •Persons under court protection, guardianship or curatorship
- Hypersensitivity to prednisone
- • Any infectious condition requiring systemic treatment
- - Evolving viruses (including hepatitis, herpes, chickenpox, shingles)
- Patient on immunosuppressive therapy at inclusion
- - Psychotic states not yet controlled by treatment
- - Immunization with a live vaccine within 8 weeks of starting treatment
- - Pregnant women (for non-menopausal women, negative high-sensitivity pregnancy test)
- - Women of childbearing age without effective contraception
- • Giant cell arteritis in relapse
- • Persistent severe dementia
- • Non-observant patient
- • Patient living more than 150 km from the investigating center
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.