Abatacept for the Treatment of Giant Cell Arteritis
Eligible age
50+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months.
Sponsor: University of Pennsylvania
You may qualify if…
- ✓ 1. A diagnosis of newly diagnosed or relapsing GCA. Diagnostic criteria for GCA
- ✓ A patient will be said to have GCA by meeting 3 of 5 of the following modified ACR criteria for the classification of GCA in which 1 of the 3 must consist of criteria 4 or 5:
- ✓ 1. Age at disease onset ≥ 50 years.
- ✓ 2. New onset or new type of localized pain in the head.
- ✓ 3. ESR of \> 40 mm in the first hour by the Westergren method or CRP measurement above the laboratory normal limit.
- ✓ 4. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries).
- ✓ 5. Temporal artery or large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cell or an abnormal temporal artery ultrasound showing features consistent with active giant cell arteritis ("halo sign") or characteristic changes of large vessel stenosis or aneurysm by arteriography.
- ✓ 2. GCA with evidence of active disease (defined below) present within the past 8 weeks.
You may not qualify if…
- ✕ 1. Evidence of a recent acute infection defined as:
- ✕ 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:
Where it's recruiting
Source: ClinicalTrials.gov · NCT04474847 · last updated 2026-01-23