NCT00578565已完成3 期
Rituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot Study
Eric Matteson2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Diffusion Capacity for Carbon Monoxide (DLco) From Baseline to 48 Weeks
研究概览
简要总结
This study will examine the course of patients with progressive rheumatoid arthritis associated interstitial lung disease (RA-ILD) treated with rituximab for safety and progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be assessed through patient history, physical exams and laboratory parameters.
- Twelve male/or female patient with RA-associated lung disease (6 of each nonspecific interstitial pneumonia (NSIP) and usual interstitial pneumonia (UIP) histological subtype) will be enrolled
- The study involves 12 visits over 48 weeks
- Rituximab will be administered intravenously at Day 1 and Day 15 with repeat dosing at six months.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA according to the revised 1987 American Rheumatism Association criteria
- •Absence of clinical features suggesting infection, neoplasm, sarcoidosis, interstitial lung disease other than UIP or NSIP, other collagen vascular disease, or exposure to known fibrogenic drugs or environmental factors
- •Diagnosis of progressive interstitial pneumonia of UIP or NSIP subtype, based on the following criteria
- •Clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening.
- •Worsening as demonstrated by any one of the following within the past year:
- •> 10% decrease in Forced Vital Capacity (FVC)
- •increasing infiltrates on chest X-ray or High Resolution Computed Tomography (HRCT), or worsening dyspnea at rest or on exertion
- •Diagnosis of UIP or NSIP by either of the following:
- •Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP or NSIP
- •HRCT scan showing definite or probable UIP or NSIP AND abnormal pulmonary function tests (reduced FVC or decreased diffusing capacity of carbon monoxide (DLco) or impaired gas exchange at rest or with exercise) AND insidious onset of otherwise unexplained dyspnea or exertion and bibasilar, inspiratory crackles on auscultation
- •FVC > 50% of predicted value at Screening
- •DLco >30% of predicted value at Screening
- •No change of disease-modifying anti-rheumatic drug (DMARD) treatment within the last 3 months
排除标准
- •History of clinically significant environmental or drug exposure known to cause pulmonary fibrosis.
- •Forced expiratory volume in one second (FEV1) FEV1/FVC ratio < 0.6 at screening (pre- or post-bronchodilator).
- •Residual volume > 120% predicted at Screening
- •Evidence of active infection
- •Any pulmonary condition other than UIP/NSIP, which, in the opinion of the site principal investigator, is likely to result in the death of the patient within the next year
- •History of unstable or deteriorating cardiac or neurologic disease
- •Pregnancy or lactation
- •Treatment with cyclophosphamide, cyclosporine, interferon gamma or beta, anti-tumor necrosis factor therapy, anti-interleukin 1 (IL1) therapy or with endothelin receptor blockers within the last 8 weeks; experimental therapy for rheumatoid arthritis
- •Creatinine > 1.5 X upper limit of normal range (ULN) at Screening
- •Hematology outside of specified limits: white blood cell (WBC) < 2,500/mm^3 or absolute neutrophil count (ANC) < 1500
- •Hematocrit < 27% or > 59%, platelets < 100,000/mm^3 at screening
- •Positive hepatitis B or C serology
- •Any medical condition, which in the opinion of the site principal investigator, may be adversely affected by the participation in this study
- •History of recurrent significant infection or history of recurrent bacterial infections
- •Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- •Abnormal neurological examination reflective of central nervous disease, including paresis, cognitive impairment and problems with coordination
- •Current enrollment in another clinical trial
- •Fever (>99.5º F)
- •History of previous rituximab administration
- •Receipt of any vaccine, particularly live viral vaccines, within 4 weeks of first study dose
- •Decreased Immunoglobulin G (IgG) and Immunoglobulin M (IgM) levels (below lower limit of normal range)
- •Present or past malignancy
- •History of severe allergic or anaphylactic reaction to administration of humanized or murine monoclonal antibodies
- •Positive human immunodeficiency virus (HIV) serology
研究组 & 干预措施
1
Experimental
open label, all subjects will receive rituximab
干预措施: Rituximab (Drug)
结局指标
主要结局
Change in Diffusion Capacity for Carbon Monoxide (DLco) From Baseline to 48 Weeks
时间窗: baseline, 48 weeks
DLco is one pulmonary function measure. For DLco, worsening was defined as decrease of at least 15% and improvement was defined as increase of at least 15%.
Change in Forced Vital Capacity (FVC) From Baseline to 48 Weeks
时间窗: baseline, 48 weeks
FVC is one measure of pulmonary function. For FVC, worsening was defined as decrease of at least 10% and improvement was defined as increase of at least 10%.
次要结局
- Change in Lung Fibrosis Score as Observed on High Resolution Computerized Tomography (HRCT) Scans, From Baseline to 48 Weeks(baseline, 48 weeks)
- Assessment of RA Disease Activity Scores as Measured by the DAS28 Score at Baseline and 48 Weeks(baseline, 48 weeks)
- Change in RA Disease Activity From Baseline to 48 Weeks Using the DAS28 Score.(baseline, 48 weeks)
- Percentage of Change in Health Associated Quality of Life From Baseline to 48 Weeks(baseline, 48 weeks)
研究者
Eric Matteson
MD
Mayo Clinic
研究点 (2)
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