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Abatacept for the Treatment of Giant Cell Arteritis

{ "Abatacept for Giant Cell Arteritis", "This study is testing a drug called abatacept for people with Giant Cell Arteritis (GCA), a condition that causes inflammation of blood vessels. Researchers want to see if abatacept can help more people achieve remission (a period where symptoms improve or disappear) compared to a placebo (an inactive substance). You might be able to join if you are 50 or older and have newly diagnosed or relapsing GCA. The study will look at how many participants in each group are in remission after 12 months. The current status of the study is unclear, and it plans to enroll 78 participants.", "design": "This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either abatacept or a placebo, and neither you nor your doctor will know which you are receiving. The study plans to enroll 78 participants.", "commitments": "Participants will receive weekly subcutaneous injections (shots under the skin) of either abatacept or placebo for 12 months. If you don't achieve remission or have a relapse, you may have the option to receive open-label abatacept for up to 12 additional months.", "compensation": "Not stated in the trial record.", "follow_up": "Participants who achieve remission will remain on their assigned treatment for 12 months, after which the treatment will be stopped. The primary outcome is measured at 12 months.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04474847

Abatacept for the Treatment of Giant Cell Arteritis

Recruiting
PHASE3Ages 50+InterventionalTreatment
University of Pennsylvania
~78 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:AbataceptPlacebo

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The proportion of participants in remission of those randomized to abatacept as compared to placebo.
Measured over 12 months

Conditions

Giant Cell Arteritis

Explore related trials

Giant Cell Arteritis

Where it's being run

10 sites across 9 states
Ontario2
Minnesota1
New York1
Ohio1
Pennsylvania1
Tennessee1
British Columbia1
Quebec1

Study leadership

  • Peter A Merkel, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
  • Carol A Langford, MD, MHS · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
  • Jeffrey P Krischer, PhD · PRINCIPAL_INVESTIGATOR · University of South Florida

Who to contact

Carol McAlear, MA
[email protected]
7813214567
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics.
Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy. 2. Patients with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.). 3. Patients with a history of recurrent herpes zoster (more than 1 episode) or disseminated (more than 1 dermatome) herpes zoster or disseminated herpes simplex, or ophthalmic zoster. Symptoms of herpes zoster or herpes simplex must have resolved more than 60 days prior to screening. 4. Patients with a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis). 5. Patients with a history of primary immunodeficiency. 6. Patients at risk for tuberculosis (TB) defined as follows:
Current clinical, radiographic or laboratory evidence of active TB, even if currently being treated. Chest x-rays (posterior/anterior and lateral) obtained within the 6 months prior to screening and TB testing (IFN-gamma release assay or PPD) performed in the past month prior to screening will be accepted; however, a copy of the reports must be placed in the participant binder.
A history of active TB unless there is documentation that the patient had received prior anti-TB treatment that was appropriate in duration and type according to local health authority guidelines.
Patients with a positive TB screening test indicative of latent TB will not be eligible for the study unless they:
Takayasu arteritis
Granulomatosis with polyangiitis
Microscopic polyangiitis
Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
Polyarteritis nodosa
Cogan's syndrome
Behçet's disease
Sarcoidosis
Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis
Cryoglobulinemic vasculitis
Systemic lupus erythematosus
Rheumatoid arthritis
Mixed connective tissue disease or any overlap autoimmune syndrome

What this trial measures

  • The proportion of participants in remission of those randomized to abatacept as compared to placebo.12 months

    Remission is defined as the absence of clinical or imaging features of active disease