Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-therapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- Number of Patients in Remission According to Disease Activity Score (DAS) 28 (< 2.6)
研究概览
简要总结
This Phase 3, randomized, open-label, multicenter study in rheumatoid arthritis (RA) patients with low disease activity (Disease Activity Score 28 [DAS28] >2.8 and <3.5) is being conducted to evaluate induction of remission by adding infliximab to pre-existing treatment versus no additional treatment. All subjects eligible for this study, aged >35 to <=65 years, will have a diagnosis of RA according to American College of Rheumatology (ACR) criteria, and will be offered additional treatment with infliximab. Prior to the start of treatment, subjects must be on a stable regimen of disease modifying antirheumatic drugs (DMARDs) for at least 3 months. Subjects will be randomized (1:1) to basic therapy with or without infliximab for a total duration of 38 weeks followed by a follow-up period of up to 6 months. Subjects randomized to basic therapy + infliximab will receive infliximab 3 mg/kg at Weeks 0, 2, 6, 14, 22, 30, and 38. The primary objective of the study is to assess the rate of remission according to DAS 28 (<2.6) at the end of treatment (after 38 weeks). Safety assessments include the incidence of adverse events, serious adverse events, and clinically notable abnormal vital signs and laboratory values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >35 and <=65 years with a diagnosis of rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria for at least 1 year and no more than 10 years prior to start of therapy; have active disease (Disease Activity Score [DAS] 28 >2.8 and <3.5), with changes in the DAS 28 score <0.6 within the 6 weeks before inclusion; have stable RA basic therapy according to standard criteria for at least 3 months; have a chest X-ray within 1 month prior to first infusion with no evidence of malignancy, infections, or fibrosis; and have screening laboratory test results that meet prespecified criteria. Patient must have at least one swollen joint. Patient must have evidence of erosive disease by x-ray at baseline.
排除标准
- •Patients were excluded if they met any of the following criteria:
- •Women who are pregnant, nursing, or planning pregnancy within 15 months after screening (i.e., approximately 6 months following last infusion);
- •Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer;
- •History of any other therapeutic agent targeted at reducing tumor necrosis factor (TNF);
- •History of previous administration of infliximab;
- •History of receiving human/murine recombinant products or has a known allergy to murine products;
- •Serious infection (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.
- •Active tuberculosis (TB) or evidence of latent TB (positive purified protein derivative [PPD] skin test, a history of old or latent TB or chest X-ray without adequate therapy for TB initiated prior to first infusion of study drug), or evidence of an old or latent TB infection without documented adequate therapy. Patients with a current close contact with an individual with active TB and patients who have completed treatment for active TB within the previous 2 years are explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies.
- •Hepatitis B surface antigen or Hepatitis C (HCV) antibody positive; documented Human Immunodeficiency Virus (HIV) infection;
- •Have an opportunistic infection, including but not limited to evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterium infection, etc, within the previous 6 months;
- •Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, psychiatric, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis);
- •Concomitant congestive heart failure >= New York Heart Association (NYHA) II;
- •Have a transplanted organ (with the exception of a corneal transplant >3 months prior to screening);
- •Fibromyalgia;
- •Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence);
- •History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or peri-aortic areas), or splenomegaly; or
- •Known recent substance abuse (drug or alcohol).
研究组 & 干预措施
Infliximab + basic treatment
3 mg/kg infliximab plus basic treatment
干预措施: infliximab (Biological)
Basic treatment (DMARDs)
Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
干预措施: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89. (Drug)
结局指标
主要结局
Number of Patients in Remission According to Disease Activity Score (DAS) 28 (< 2.6)
时间窗: after 38 weeks
The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Patients can be scored on a range of 0 to 10, with lower scores indicating less disease activity.
次要结局
- DAS 28 at Baseline vs at Week 38; Quality of Life; American College of Rheumatology (ACR) Response Disease Progression (X-ray); Effect of Inflammatory Markers on Response and Disease Progression; Assess Simplified Disease Activity Index (SDAI).(Weeks 14, 38, and 62)