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New treatment option for Giant Cell Arteritis
Official title Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering
ClinicalTrials.gov ID: NCT04012905
What this study is testing
What is Corticosteroids for Systemic Use?
Corticosteroids for Systemic Use is an investigational medicine, being studied as a potential treatment for giant cell arteritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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
You likely can't join if
- people checking one of the criteria for non-inclusion may be eligible to participate in the research. These criteria may include:
- Early treatment of CAG disease with a dose\> 1 mg / kg whatever the duration
- Corticosteroids already started over 14 days
- Giant arteritis cell on relapse
- dementia syndrome
- No compliant patient
See the full eligibility criteria
- 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
- people checking one of the criteria for non-inclusion may be eligible to participate in the research. These criteria may include:
- Early treatment of CAG disease with a dose\> 1 mg / kg whatever the duration
- Corticosteroids already started over 14 days
- Giant arteritis cell on relapse
- dementia syndrome
- No compliant patient
- Patients who live more than 150 km from the investigation center
- Person under judicial protection, guardianship
- Hypersensitivity to prednisone or any of its excipients
- Infection requiring an systemic treatment
- Evolutive viroses (Hepatitis, Herpes, varicella-zoster virus)
- Immunization with live vaccines / mitigated during the 8 weeks preceding inclusion
- Pregnancy, breastfeeding women or women of childbearing potential not using contraception
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
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 study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.