Actively Recruiting
Randomized Double-Blind Placebo-Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis
Led by University of Pennsylvania · Updated on 2026-01-23
78
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of abatacept, given by weekly injection, in people aged 50 and older who have been newly diagnosed with or have relapsing Giant Cell Arteritis (GCA). This is a Phase 3 randomized, double-blind, placebo-controlled trial aiming to compare abatacept with placebo in achieving remission of GCA. The study is sponsored by the University of Pennsylvania and includes patients with active disease within 8 weeks prior to screening. Participants will be randomly assigned to receive either abatacept 125 mg or a placebo by subcutaneous injection once a week for at least 12 months. Those who reach remission will continue their assigned treatment for 12 months before stopping. If a participant does not achieve remission by 3 months, or experiences a relapse or disease worsening within the first year, they may enter an open-label phase to receive abatacept for up to 12 months. During the study, participants will be monitored regularly to assess remission status, safety, and quality of life using questionnaires like SF-36 and PROMIS. Researchers will measure the proportion of participants in remission at 12 months, duration of glucocorticoid-free remission, and the safety of abatacept. The total involvement may last up to 24 months if the participant enters the open-label extension. Close follow-up will ensure treatment adherence and assess any disease progression or side effects.
CONDITIONS
Brief 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
- Active disease present within 8 weeks prior to screening
- Age 50 years or older at disease onset
- Willingness and ability to comply with treatment and follow-up
- Women and men of child-bearing potential must use effective contraception
- Able to provide written informed consent
You will not qualify if you...
- Recent acute infection requiring hospitalization or intravenous antibiotics within 60 days
- Recent acute infection requiring oral antimicrobial or antiviral therapy within 30 days
- History of chronic or recurrent bacterial infections
- History of recurrent or disseminated herpes zoster or herpes simplex infections
- History of systemic fungal infections
- History of primary immunodeficiency
- Risk for tuberculosis without appropriate treatment or evidence of active TB
- Pregnant or nursing women
- Inability to comply with study guidelines
- Cytopenia or severe blood count abnormalities
- Renal insufficiency with creatinine clearance ≤ 20 ml/min
- Elevated liver enzymes (AST or ALT > 3 times normal)
- Severe or uncontrolled diseases that increase study risk
- Current or recent malignancy except certain cured skin or cervical cancers
- Recent use of investigational agents or live vaccines
- Use of non-biologic immunosuppressants or certain biologic agents within specified timeframes
- 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 specific autoimmune or vasculitis diseases such as Takayasu arteritis, granulomatosis with polyangiitis, systemic lupus erythematosus, rheumatoid arthritis, and others listed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 12 months, with possible extension up to 12 additional months during open-label period
Participants receive weekly subcutaneous injections of either abatacept or placebo. Treatment lasts for at least 12 months unless participants experience disease relapse, worsening, or do not achieve remission, at which point they may enter an open-label treatment period with abatacept for up to 12 months.
Weekly visits for injections and assessments
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
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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