Giant Cell ArteritisPhase 3NCT04474847
Abatacept for the Treatment of Giant Cell Arteritis
A Phase 3 study testing Abatacept in people with Giant Cell Arteritis, run by University of Pennsylvania at 10 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 29 Mar 2021to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Age at disease onset ≥ 50 years.
- New onset or new type of localized pain in the head.
- ESR of > 40 mm in the first hour by the Westergren method or CRP measurement above the laboratory normal limit.
- Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries).
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- 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.
- GCA with evidence of active disease (defined below) present within the past 8 weeks.
- They must be willing and able to comply with treatment and follow-up procedures.
- Both women and men who are of child-bearing potential must be willing to use an effective means of birth control while receiving treatment through this study. Effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception.
- They must be willing and able to provide written informed consent.
Who cannot join
- 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.
- Patients with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.).
- 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.
- Patients with a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis).
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- Patients with a history of primary immunodeficiency.
- 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:
- Have no evidence of current TB based on chest x-ray performed during the screening period and by history and physical exam, and ii. They are currently being treated for latent TB or the site has documentation of successful prior treatment of latent TB. Treatment regimens should be dictated by local guidelines as long as the treatment dose and duration meet or exceed local health authority guidelines. If permitted by local guidelines regarding treatment with biologic medications, patients with latent TB may be randomized prior to completion of treatment as long as they have completed at least 4 weeks of treatment and they have no evidence of current TB on chest x-ray at screening.
- Patients who are pregnant or who are nursing infants.
- Inability to comply with study guidelines.
- Cytopenia: platelet count <80,000/mm3, total White Blood Count (WBC) < 3,000/mm3 (3 x 109/L) absolute neutrophil <1500/mm3, hematocrit < 20%.
- Renal insufficiency defined by a creatinine clearance of less than or equal to 20 ml/min.
- AST or ALT > 3 times above normal laboratory range.
- Other severe, progressive, or uncontrolled disease that in the investigator's opinion could prevent a patient from fulfilling the study requirements or that would increase the risk of study participation.
- Patients who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Patients who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
- Receipt of an investigational agent or device within 30 days prior to enrollment.
- A live vaccination within 3 months before randomization.
- Patients on non-biologic immunosuppressants must discontinue these medications before randomization (azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, hydroxychloroquine, cyclosporin, tacrolimus, or other conventional immunosuppressive agent).
- Patients who had received an alkylating agent such as cyclophosphamide must discontinue these medications at least 8 weeks before randomization.
- Patients who have been treated within 4 weeks of randomization with etanercept or within 8 weeks with adalimumab, certolizumab, golimumab, or infliximab.
- Patients who have been treated within 8 weeks of randomization with anti-IL-6 agents (e.g., tocilizumab, sirukumab) or a janus kinase inhibitor.
- Patients who have been treated within 4 weeks of randomization with anakinra.
- Patients who have received prior treatment with rituximab within the past 6 months prior to randomization.
- Patients who have received prior treatment with abatacept or CTLA4-Ig.
- Patients who will require oral or IV glucocorticoid treatment during the trial for conditions other than GCA.
- Hypersensitivity to abatacept and/or its excipients.
- Presence of any of the following disease processes:
- 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
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
United States5 sites, 5 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Sonya Crook, CROOKS@ccf.org
Carol Langford, MD, MHS
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37240
Pamela Schlairet, pamela.schlairet@vumc.org
Kevin Byram, MD
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Janvi Bhatia, bhatiaj@hss.edu
Robert Spiera, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jessica Nguyen, Jessica.Nguyen2@PennMedicine.upenn.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jennifer Sletten, Sletten.Jennifer@mayo.edu
Kenneth Warrington, MD
Canada4 sites, 3 recruiting
- Active, not recruiting
St. Joseph's Healthcare
Hamilton, Ontario
- Recruiting
Hôpital du Sacré-Coeur de Montréal Université de Montréal
Montreal, Quebec, H4J 1C5
Guylaine Marcotte, guylaine.marcotte.cnmtl@ssss.gouv.qc.ca
Jean-Paul Makhzoum, MD, MSc, FRCPC, FACP
- Recruiting
Mount Sinai Hospital
Toronto, Ontario
Nazrana Haq, Nazrana.Haq@sinaihealth.ca
Christian Pagnoux, MD, MS, MPH
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6Z 2C7
Sofia Rieger-Torres, srieger-torres@arthritisresearch.ca
Germany1 site, 1 recruiting
- Recruiting
medius KLINIK KIRCHHEIM
Kirchheim unter Teck, 73230
Nicole Hollinger, n.hollinger@medius-kliniken.de
About this study
Official title: A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)
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
- Giant Cell Arteritis
- Being tested
- Abatacept, Placebo
- Keywords
- Vasculitis, Arteritis, Temporal Arteritis, Abatacept, CTLA4-Ig, Autoimmune Diseases, Immune System Diseases, Immunosuppressive agent, Prednisone, Glucocorticoids, Corticosteroids, Treatment, Pharmacologic Actions, Therapeutic Uses, Anti Inflammatory Agents, Antirheumatic Agents
- Medical subject headings
- Giant Cell Arteritis, Vasculitis, Arteritis, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called CTLA4-Ig, Orencia
Participants randomized to abatacept will receive abatacept 125 mg administered by subcutaneous injection once a week. Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 3 will have the option of entering an open-label trial period whereby they would receive open-label abatacept for up to 12 months.
PlaceboDrug
Participants randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week. Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 3 will have the option of entering an open-label trial period whereby they would receive open-label abatacept for up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Blinded Abatacept | Experimental | Participants will receive blinded abatacept 125 mg administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission. Receives: Drug: Abatacept |
| Blinded Placebo | Placebo comparator | Participants will receive blinded placebo. Placebo will be administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants in remission of those randomized to abatacept as compared to placebo.
Remission is defined as the absence of clinical or imaging features of active disease
Measured: 12 months
Secondary outcomes (4)
Safety of abatacept in GCA
Safety of abatacept in patients with GCA as assessed by reported adverse events.
Measured: 12 months
Health-related quality of life in those treated with abatacept versus placebo: SF-36
Health-related quality of life in those treated with abatacept versus placebo as assessed using the SF-36
Measured: 12 months
Health-related quality of life in those treated with abatacept versus placebo: PROMIS questionnaire
Health-related quality of life in those treated with abatacept versus placebo as assessed using a PROMIS questionnaire
Measured: 12 months
Duration of glucocorticoid-free remission from Month 6 to Month 12
Effect of abatacept on increasing duration of glucocorticoid-free periods for participants.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start29 Mar 2021
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter A Merkel, MD, MPH, Principal investigator, University of PennsylvaniaCarol A Langford, MD, MHS, Principal investigator, The Cleveland ClinicJeffrey P Krischer, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474847
- Sponsor's protocol ID
- VCRC5528
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)
- ClinicalTrials.gov ID
- NCT04474847
- Acronym / sponsor ID
- VCRC5528
- Conditions
- Giant Cell Arteritis
- Keywords
- Vasculitis, Arteritis, Temporal Arteritis, Abatacept, CTLA4-Ig, Autoimmune Diseases, Immune System Diseases, Immunosuppressive agent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded Abatacept | Experimental | Drug: AbataceptParticipants will receive blinded abatacept 125 mg administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission. |
| Blinded Placebo | Placebo comparator | Drug: PlaceboParticipants will receive blinded placebo. Placebo will be administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- GCA with evidence of active disease (defined below) present within the past 8 weeks.
- They must be willing and able to comply with treatment and follow-up procedures.
- Both women and men who are of child-bearing potential must be willing to use an effective means of birth control while receiving treatment through this study. Effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception.
Key exclusion criteria (44 listed)
- Evidence of a recent acute infection defined as:
- Patients with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.).
- 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.
- Patients with a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis).
- Patients with a history of primary immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: CTLA4-Ig, OrenciaParticipants randomized to abatacept will receive abatacept 125 mg administered by subcutaneous injection once a week. Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 3 will have the option of entering an open-label trial period whereby they would receive open-label abatacept for up to 12 months. | Drug | Blinded Abatacept |
| PlaceboParticipants randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week. Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 3 will have the option of entering an open-label trial period whereby they would receive open-label abatacept for up to 12 months. | Drug | Blinded Placebo |
Primary outcome
The proportion of participants in remission of those randomized to abatacept as compared to placebo.
Time frame: 12 months
Remission is defined as the absence of clinical or imaging features of active disease
4 secondary outcomes
Safety of abatacept in GCA
Time frame: 12 months
Health-related quality of life in those treated with abatacept versus placebo: SF-36
Time frame: 12 months
Health-related quality of life in those treated with abatacept versus placebo: PROMIS questionnaire
Time frame: 12 months
Duration of glucocorticoid-free remission from Month 6 to Month 12
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abatacept in people with Giant Cell Arteritis, run by University of Pennsylvania at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol McAlear, MA (7813214567, cmcalear@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants in remission of those randomized to abatacept as compared to placebo. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.