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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

13 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

Abatacept – A biological medication administered via intravenous infusion or subcutaneous injection that is currently FDA-approved for treatment of rheumatoid arthritis and being investigated for Giant Cell Arteritis (GCA) in clinical trials. Abatacept works by blocking T-cell activation through binding to CD80 and CD86 on antigen-presenting cells, thereby inhibiting the costimulatory signal needed for T-cell activation and reducing inflammation in affected blood vessels. As a selective T-cell costimulation modulator, abatacept represents a potential treatment option for GCA patients by targeting the immune system dysfunction that contributes to vascular inflammation, with researchers evaluating its ability to maintain disease remission compared to standard therapies.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515287-31-00Protocol codeVCRC5528- ABAGARTEstimated enrolment78 patientsSponsorTrustees Of The University Of Pennsylvania

sourced from the EU Clinical Trials Register and site verification

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