2024-515287-31-00招募中3 期
A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The primary study endpoint will be the proportion of individuals in remission at Month 12 of those randomized to abatacept as compared to placebo.
研究概览
简要总结
This protocol seeks to determine the efficacy of abatacept (CTLA4-Ig) in patients with GCA through the conduct of a randomized, double-blind, placebo-controlled trial. The studies primary endpoint will be the proportion of individuals in remission at Month 12 of those randomized to abatacept as compared to placebo.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Open-Label Abatacept Treatment Phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of newly diagnosed or relapsing GCA
- •GCA with evidence of active disease (defined below) present within the past 8 weeks prior to trial entry
- •Participant 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.
排除标准
- •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, or any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy.
- •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 4 weeks of randomization with anti-IL-6 agents (e.g., tocilizumab, sirukumab) or a janus kinase inhibitor.
- •Patients with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.).
- •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.
- •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.
- •Patients at risk for tuberculosis (TB) defined as follows: 1) 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. 2) 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. 3) 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 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%.
结局指标
主要结局
The primary study endpoint will be the proportion of individuals in remission at Month 12 of those randomized to abatacept as compared to placebo.
The primary study endpoint will be the proportion of individuals in remission at Month 12 of those randomized to abatacept as compared to placebo.
次要结局
- Safety (adverse events/serious adverse events/SUSARs) in patients with GCA taking abatacept compared with placebo
- Patient reported outcomes (Mean change from Baseline/Month 0 over time to Month 12 in SF-36, PROMIS) in patients with GCA taking abatacept compared with placebo
- Median duration of glucocorticoid-free remission from Month 6 to Month 12 in patients with GCA taking abatacept compared with placebo
研究者
Carol McAlear
Scientific
Trustees Of The University Of Pennsylvania
研究点 (2)
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