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New treatment option for Giant Cell Arteritis
Official title Abatacept for the Treatment of Giant Cell Arteritis
ClinicalTrials.gov ID: NCT04474847
What this study is testing
What is Abatacept?
Abatacept is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for giant cell arteritis.
Also referred to as CTLA4-Ig, Orencia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Patients with a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis).
See the full eligibility criteria
Who can 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...
- 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).
- 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...
- 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...
- They must be willing and able to provide written informed consent.
What rules you out
- 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...
- Patients with a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis).
- 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...
- 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: i. Have no evidence of current TB based on chest x-ray performed during the screening period and by...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; New York, New York, United States; Cleveland, Ohio, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; Vancouver, British Columbia, Canada and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.