NCT02955147终止1 期
Open Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell Arteritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Percentage of Patients in Glucocorticoid-free Remission
研究概览
简要总结
The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA)
详细描述
The objective of this study is to evaluate the efficacy and safety of ustekinumab, an interleukin (IL)-12/23 inhibitor, in patients with GCA
Hypothesis IL-12/23 pathway blockade may maintain disease remission in patients with GCA
Specific Aims
- To evaluate the safety and tolerability of ustekinumab administration in 20 patients with GCA
- To evaluate the efficacy of ustekinumab for remission maintenance and glucocorticoid sparing in 20 patients with GCA
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following criteria
- •Able and willing to provide written informed consent and to comply with the study protocol
- •Diagnosis of GCA classified according to the following criteria:
- •Age 50 years or older
- •History of erythrosedimentation rate (ESR) ≥ 50 mm/hour or C-reactive protein (CRP) ≥ 10 mg/L
- •AND at least one of the following:
- •Cranial symptoms of GCA
- •Symptoms of polymyalgia rheumatica (PMR)
- •AND at least one of the following:
- •Temporal artery biopsy revealing features of GCA
- •Evidence of large-vessel vasculitis by angiography or cross-sectional imaging
- •Active new-onset or relapsing active disease
排除标准
- •Allergies: Subjects who have history of previous severe allergic or anaphylactic reaction associated with the administration of monoclonal antibodies or antibody fragments.
- •Systemic infection: Subjects who have an active systemic infection.
- •Serious infection: Subjects who have had serious infections, or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of enrollment.
- •Chronic or recurrent infection: Subjects who have chronic or recurrent bacterial, viral, fungal, mycobacterial, or protozoan infection.
- •Opportunistic infection: Subjects who have, or have had, an opportunistic infection within 6 months prior to enrollment.
- •Subjects who have active hepatitis B or active hepatitis C or a documented history of HIV
- •Latent tuberculosis infection
- •Subjects with evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, immunologic, psychiatric or gastrointestinal disease that could interfere with participation in the trial according to the protocol.
- •Subjects with transplanted organs (with the exception of a corneal transplant > 3 months prior to screening)
- •Major surgery within 8 weeks prior to Screening or planned major surgery within 12 months after Baseline
- •The following laboratory abnormalities
- •Hemoglobin < 8 gr/dL
- •Platelets < 100/mm3
- •White blood cell count (WBC) < 3000/mm3
- •Absolute neutrophil count < 2000/mm3
- •Absolute lymphocyte count < 500/mm3
- •Serum creatinine > 1.4 mg/dL in female subjects and > 1.6 mg/dL in male subjects
- •Total bilirubin > 2 mg/dL
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 X upper limit of normal
- •Positive hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibody
- •Prohibited medications:
- •Subjects who received methotrexate (MTX) > 30 mg weekly, azathioprine, mycophenolate mofetil, cyclophosphamide, chlorambucil, tacrolimus, leflunomide, canakinumab, belimumab, abatacept, tocilizumab, secukinumab, infliximab, etanercept, adalimumab, golimumab, or certolizumab within the 3-month period prior to enrollment.
- •Subjects who had treatment with any anti-cluster designation antigen (CD)20 agent (e.g., rituximab) within the 9-month period prior to enrolment
- •Subjects who used any investigational drug within 1 month prior to enrollment or within 5 half-lives of the investigational agent, whichever is longer.
- •Low dose MTX: Patients on < 30 mg of MTX weekly will be eligible for enrollment after a 2-week washout interval before receiving ustekinumab
- •Vaccines: Subjects who received any live virus or bacterial vaccinations other than bacille Calmette-Guerin (BCG) within the 3 months before the first administration of the study agent, or are expected to receive any live virus or live bacterial vaccinations during the study, or up to 3 month after the last administration of ustekinumab are not eligible. Subjects who received BCG vaccines within the 12 months before the first administration of the study agent, or are expected to receive BCG vaccines during the study, or up to 12 month after the last administration of ustekinumab are also not eligible.
研究组 & 干预措施
Ustekinumab plus prednisone
Experimental
- Ustekinumab: 90 mg of ustekinumab will be administered subcutaneously at baseline, week 4, week 12, week 20, week 28, week 36 and week 44.
- Prednisone: All patients will receive a prednisone course tapered according to predefined schedules starting at either 60 mg, 40 mg or 20 mg. The initial dose of prednisone will be chosen by the investigators according to disease severity and comorbid medical conditions. The duration of the prednisone taper will be 6 months in all cases.
干预措施: Ustekinumab (Drug)
Ustekinumab plus prednisone
Experimental
- Ustekinumab: 90 mg of ustekinumab will be administered subcutaneously at baseline, week 4, week 12, week 20, week 28, week 36 and week 44.
- Prednisone: All patients will receive a prednisone course tapered according to predefined schedules starting at either 60 mg, 40 mg or 20 mg. The initial dose of prednisone will be chosen by the investigators according to disease severity and comorbid medical conditions. The duration of the prednisone taper will be 6 months in all cases.
干预措施: Prednisone (Drug)
结局指标
主要结局
Percentage of Patients in Glucocorticoid-free Remission
时间窗: 52 weeks
The primary study endpoint, prednisone-free remission, was defined as: 1) absence of relapse from the time that remission was achieved through week 52; 2) normalization of ESR (\<40 mm/hour) and CRP (\<10 mg/L); and, 3) adherence to the protocol prednisone taper.
次要结局
- Number of Participants With Disease Flare(52 weeks)
- Cumulative Prednisone Dose(52 weeks)
研究者
Sebastian H Unizony, MD
MD
Massachusetts General Hospital
研究点 (1)
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