Actively Recruiting
Abatacept for the Treatment of Giant Cell Arteritis
Led by University of Pennsylvania · Updated on 2026-01-23
78
Participants Needed
9
Research Sites
452 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Abatacept for the Treatment of Giant Cell Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of newly diagnosed or relapsing Giant Cell Arteritis meeting at least 3 of 5 modified ACR criteria, including temporal artery abnormality or biopsy/ultrasound evidence
- Evidence of active Giant Cell Arteritis within 8 weeks prior to screening
- Age 50 years or older at disease onset
- Ability and willingness to comply with treatment and follow-up procedures
- Women and men of child-bearing potential willing to use effective contraception during the study
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Acute infection requiring hospitalization or parenteral antibiotics within 60 days prior to randomization
- Acute infection requiring oral antimicrobial or antiviral therapy within 30 days prior to randomization
- History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis)
- History of recurrent or disseminated herpes zoster or herpes simplex infections
- History of systemic fungal infections (e.g., histoplasmosis, blastomycosis)
- History of primary immunodeficiency
- Active or untreated latent tuberculosis or inadequate prior treatment
- Pregnancy or nursing infants
- Inability to comply with study guidelines
- Cytopenia with specific blood count thresholds
- Renal insufficiency with creatinine clearance ≤ 20 ml/min
- Elevated liver enzymes (AST or ALT > 3 times above normal)
- Other severe or uncontrolled diseases that may increase study risk
- Current or recent malignancy within 5 years except certain skin or cervical cancers
- Receipt of investigational agents within 30 days prior to enrollment
- Live vaccination within 3 months before randomization
- Use of certain immunosuppressive medications or biologics within specified timeframes before randomization
- Prior treatment with abatacept or CTLA4-Ig
- Need for glucocorticoid treatment for conditions other than GCA during the trial
- Hypersensitivity to abatacept or its components
- Presence of other specified autoimmune or vasculitis diseases such as Takayasu arteritis, granulomatosis with polyangiitis, rheumatoid arthritis, systemic lupus erythematosus, and others
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Vanderbilt University
Nashville, Tennessee, United States, 37240
Actively Recruiting
6
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 2C7
Actively Recruiting
7
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Actively Recruiting
8
Mount Sinai Hospital
Toronto, Ontario, Canada
Actively Recruiting
9
Hôpital du Sacré-Coeur de Montréal Université de Montréal
Montreal, Quebec, Canada, H4J 1C5
Actively Recruiting
Research Team
C
Carol McAlear, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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