Study on the Effectiveness of Abatacept for Patients with Giant Cell Arteritis

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What is this study about?

This study is investigating the effectiveness of abatacept (CTLA4-Ig) for treating Giant Cell Arteritis (GCA). Giant Cell Arteritis is an inflammatory condition that affects the large and medium-sized arteries, particularly those in the head and neck. The inflammation causes the arteries to narrow, reducing blood flow to the affected areas and potentially leading to symptoms such as headaches, jaw pain, and vision problems.

The purpose of this research is to determine whether abatacept is effective in achieving remission (absence of disease activity) in people with Giant Cell Arteritis. Participants in this study will receive either abatacept or placebo along with standard treatment. Abatacept works by modifying the immune system response that causes inflammation in the blood vessels.

During the 12-month study period, participants will be monitored for disease remission, safety of the treatment, and how the treatment affects their quality of life. Participants will also be assessed for their ability to stop taking glucocorticoids (steroid medications commonly used to treat inflammatory conditions) while maintaining remission of their disease.

1 Beginning of the trial

After being diagnosed with Giant Cell Arteritis (GCA) (either newly diagnosed or relapsing) with active disease within the past 8 weeks, you will enter the clinical trial.

You will be randomly assigned to receive either abatacept (the study medication) or a placebo (an injection that looks identical but contains no active medication).

Neither you nor the research team will know which treatment you are receiving during the study. This is called a ‘double-blind’ study design.

2 Treatment period

You will receive injections of either abatacept (125 mg per syringe) or placebo as a solution for injection.

You will also be on a glucocorticoid (steroid) treatment, which is standard care for GCA. The dose of this medication will be gradually reduced during the study.

Throughout the 12-month trial period, you will need to continue with all scheduled treatments and follow all medical instructions provided by the research team.

You will need to use effective birth control methods during the study if you are of childbearing potential. These methods include abstinence, surgical sterilization, barrier methods (diaphragm, condom, cap, or sponge), or hormonal contraception.

3 Monitoring and assessments

You will attend regular clinic visits where your health status will be evaluated.

The research team will monitor how your disease responds to treatment and will check for any side effects or adverse events.

You will complete questionnaires about your health and quality of life, including SF-36 and PROMIS (patient-reported outcome measures that assess physical and mental health).

Blood tests and other clinical examinations will be performed to monitor your condition and the safety of the treatment.

4 Glucocorticoid reduction phase

Around month 6, if your condition allows, the medical team will begin trying to reduce and potentially stop your glucocorticoid medication.

The study will track how long you can remain in remission without needing glucocorticoids between months 6 and 12.

This is an important outcome of the study, as reducing long-term steroid use while controlling the disease is a key goal of the treatment.

5 Study completion

At month 12, a final assessment will determine if you are in remission from Giant Cell Arteritis.

The primary goal of the study is to compare how many patients achieve remission by month 12 in the abatacept group versus the placebo group.

After completing the 12-month trial period, you will have finished your participation in the study.

The overall findings from the study will help determine if abatacept is effective for treating Giant Cell Arteritis.

Who Can Join the Study?

You must have a diagnosis of giant cell arteritis (GCA) that is either newly diagnosed or relapsing (coming back after previous treatment)
You must have evidence of active GCA disease within the past 8 weeks before entering the trial
You must be willing and able to follow all treatment and follow-up procedures required by the study
If you can become pregnant or can cause pregnancy, you must be willing to use effective birth control methods during the study. These include:
- Abstinence (not having sex)
- Surgical sterilization (of either partner)
- Barrier methods (diaphragm, condom, cap, or sponge)
- Hormonal contraception (birth control pills, patches, etc.)
You must be willing and able to provide written informed consent (official permission to participate in the study)

Who Cannot Join the Study?

People who are unable to provide informed consent
Individuals with a history of allergic reaction to abatacept (the study medication)
Pregnant or breastfeeding women
People with active tuberculosis (an infectious disease that mainly affects the lungs)
Individuals with latent tuberculosis (TB infection that is not currently causing symptoms) who cannot take preventive TB treatment
People with severe infections within the last 3 months
Individuals with hepatitis B or C (viral infections affecting the liver)
People with HIV infection (a virus that attacks the immune system)
Individuals with a history of cancer in the past 5 years (except for certain skin cancers that have been completely removed)
People with severe heart, liver, or kidney disease
Individuals taking certain medications that might interact with the study drug
People who have received live vaccines (vaccines containing weakened but living microorganisms) within 3 months before starting the study
Individuals participating in other clinical trials

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
medius KLINIKEN gGmbH	Kirchheim Unter Teck	Germany
Anedfdx Upe Ismec Di Rvglwa Eosxvb	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.05.2025
Italy	Not yet recruiting	01.05.2025

Trial locations

Investigated drugs:

Abatacept

Abatacept (CTLA4-Ig) is a medication that affects the immune system by reducing the activity of certain immune cells. It works by blocking a specific interaction between cells that leads to inflammation. In this trial, it’s being studied to see if it can help people with Giant Cell Arteritis (GCA), which is a condition where arteries become inflamed, particularly those in the head and neck.

Placebo is an inactive substance that looks like the real medication but has no therapeutic effect. It’s used as a comparison to determine if abatacept is effective. Some participants will receive the placebo instead of abatacept to help researchers determine if the real medication actually works better than no medication at all.

Investigated diseases:

Giant cell arteritis

Giant Cell Arteritis – Giant Cell Arteritis is an inflammatory disease that affects the large blood vessels, particularly the arteries in the head, neck, and upper body. It occurs when the lining of these arteries becomes inflamed, causing them to narrow and restricting blood flow. This condition most commonly affects the temporal arteries, which run along both sides of the head. Giant Cell Arteritis typically develops in adults over 50 years of age, with women being affected more frequently than men. The inflammation can lead to symptoms such as headaches, scalp tenderness, jaw pain while chewing, and vision problems. If left untreated, the disease can progress and cause more severe complications.

Trial ID:

2024-515287-31-00

Protocol code:

VCRC5528- ABAGART

NCT ID:

NCT04474847

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Abatacept for Patients with Giant Cell Arteritis

What is this study about?

Who Can Join the Study?

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