Study Comparing Two Prednisone Treatment Plans for Patients with Giant Cell Arteritis

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What is this study about?

This clinical trial is focused on studying a condition known as Giant Cell Arteritis, which is also referred to as Horton’s disease. This condition is an inflammation of the blood vessels, often affecting the arteries in the head. The study is examining the effects of a medication called Prednisone, which is a type of corticosteroid used to reduce inflammation. The trial involves two different treatment plans: a longer regimen lasting 52 weeks and a shorter regimen lasting 28 weeks. The purpose of the study is to compare these two treatment plans to see if the shorter regimen is as effective as the longer one in achieving complete remission, which means the disease is no longer active, without any relapses by the end of the study period.

Participants in the study will be randomly assigned to one of the two treatment plans. Throughout the study, they will receive either the longer or shorter course of Prednisone tablets. The study will monitor the participants’ health and any changes in their condition over the course of the treatment. The researchers will be looking at various health indicators, such as blood pressure, weight, and blood sugar levels, to ensure the safety and effectiveness of the treatment. They will also check for any side effects or complications that might arise from the use of Prednisone.

The study aims to provide valuable information on the best way to manage Giant Cell Arteritis with Prednisone, potentially offering a more efficient treatment option for patients. By comparing the two treatment plans, the researchers hope to determine whether the shorter regimen can provide the same benefits as the longer one, which could lead to improved treatment strategies for this condition in the future.

1 joining the study

Upon joining the study, the patient must meet specific criteria, including being over 50 years old and having a diagnosis of giant cell arteritis. The diagnosis is based on certain clinical criteria, such as age, headache, and specific test results.

The patient must have started oral corticosteroid therapy within the last 14 days and must provide written consent to participate.

2 treatment assignment

The patient is randomly assigned to one of two treatment groups. One group follows a short regimen of corticosteroid therapy for 28 weeks, while the other follows a long regimen for 52 weeks.

The medication used is prednisone, administered in tablet form for ocular use. The dosage and frequency are determined by the assigned regimen.

3 treatment period

During the treatment period, the patient takes prednisone as prescribed. The goal is to achieve complete remission without relapse by the end of the study period.

The patient’s health is monitored regularly, including measurements of blood pressure, weight, blood sugar levels, and other health indicators.

4 monitoring and assessments

Throughout the study, the patient undergoes regular assessments to monitor for any relapses or side effects. This includes checking for complications such as infections, fractures, glaucoma, and cataracts.

Bone density is measured at the start of the study, at 28 weeks, and at 52 weeks to assess any impact from the corticosteroid therapy.

5 end of study evaluation

At the end of the study period, the patient’s response to the treatment is evaluated. The primary focus is on the number of patients in complete remission without relapse at 52 weeks.

Secondary evaluations include the number of relapses, the duration of treatment, and any adverse events related to the therapy.

Who Can Join the Study?

Patients must be over 50 years old.
Patients must have a diagnosis of giant cell arteritis (GCA), also known as Horton’s disease. This diagnosis should be based on at least two of the following criteria:
- Age over 50 years.
- Unusual headache or tenderness in the area of the temporal artery, which is a blood vessel on the side of the head.
- Biological inflammatory syndrome, which means having a high level of inflammation in the body. This is shown by a c-reactive protein level greater than 5 mg/l or a sedimentation rate greater than 50 mm in the first hour.
Additionally, one of the following must be present:
- A positive result from a temporal artery biopsy, which is a small sample taken from the artery for testing.
- Evidence of large-vessel vasculitis, which is inflammation of large blood vessels, shown by tests like an aortic angioscan, positron emission tomography (PET), or MRI angiography.
- A positive result from a temporal artery echo-Doppler, which is an ultrasound test done by a skilled doctor.
Patients must have started taking oral corticosteroid therapy within the last 14 days. This does not include high-dose treatments given through a vein, known as boluses.
Patients must be registered with the social security system.
Patients must have given written consent to participate in the study.

Who Cannot Join the Study?

Patients who do not have giant cell arteritis (also known as Horton’s disease) cannot participate.
Individuals who are not within the specified age range for the study cannot participate.
Participants who are part of a vulnerable population are not eligible for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Public Du Cotentin	Cherbourg-En-Cotentin	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cdnmrm Hzovtyuyzin Em Uhlfelqcnagyx Dp Lslfnex	Limoges	France
Cbhymu Hmscjbhaquz Uwhjcquailkvn Dk Dnaen	Dijon	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	03.05.2021

Trial locations

Investigated drugs:

Prednisone

Cortisone is a medication used in this trial to treat giant cell arteritis, a condition that causes inflammation of the blood vessels. The trial is comparing two different treatment plans using cortisone. One plan follows a faster reduction of the medication, commonly used in North America, while the other follows a slower reduction, typically used in Europe. The goal is to see if the faster plan is just as effective as the slower one in achieving complete remission without relapse by the end of the study period.

Giant Cell Arteritis – Giant cell arteritis, also known as Horton’s disease, is an inflammatory condition affecting the large and medium-sized arteries, primarily in the head. It often causes headaches, scalp tenderness, jaw pain, and vision problems. The inflammation can lead to narrowing or blockage of the affected arteries, reducing blood flow. This condition is most common in older adults, particularly those over 50 years of age. Symptoms may develop gradually or suddenly and can vary in intensity. If left untreated, it can lead to serious complications, including vision loss.

Trial ID:

2024-518653-41-00

Protocol code:

17-249

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Two Prednisone Treatment Plans for Patients with Giant Cell Arteritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?