A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)
概览
- 阶段
- 3 期
- 干预措施
- Abatacept
- 疾病 / 适应症
- Giant Cell Arteritis
- 发起方
- University of Pennsylvania
- 入组人数
- 78
- 试验地点
- 9
- 主要终点
- The proportion of participants in remission of those randomized to abatacept as compared to placebo.
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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).
- •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.
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.
- •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).
- •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.
研究组 & 干预措施
Blinded Abatacept
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.
干预措施: Abatacept
Blinded Placebo
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.
干预措施: Placebo
结局指标
主要结局
The proportion of participants in remission of those randomized to abatacept as compared to placebo.
时间窗: 12 months
Remission is defined as the absence of clinical or imaging features of active disease
次要结局
- Safety of abatacept in GCA(12 months)
- Health-related quality of life in those treated with abatacept versus placebo: PROMIS questionnaire(12 months)
- Health-related quality of life in those treated with abatacept versus placebo: SF-36(12 months)
- Duration of glucocorticoid-free remission from Month 6 to Month 12(6 months)