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临床试验/NCT02456363
NCT02456363Unknown2 期

Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis-A Registry Project

Chung Shan Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
300
试验地点
1
主要终点
mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)

研究概览

简要总结

Assessed using (1) Adalimumab(Humira) and NSAIDs (2) Use only Adalimumab(Humira) treatment of ankylosing spondylitis patient safety and efficacy.

详细描述

In this study, single center, treatment, open, randomized, controlled clinical trial to assess Adalimumab(Humira) style with NSAIDs for the treatment of patients with ankylosing spondylitis, a total of 300 are expected to be included in the consent form signed by the subject, will be randomly assigned to treatment groups with a control group of 150 people.

Subjects to be returned in the first week outpatient follow 0,8,20,44,68,92 accept routine physical examination (weight, blood pressure, etc.), AS Scale (BASDAI, BASFI, BAS-G), fingertip ground tests, lumbar range of motion, chest expansion test, lateral bending test, the occipital bone measurements, physician global assessment (Physician global assessment), patient pain scores (VAS), AS quality of Life scale (ASQOL), SF-36 quality of life scale, Complete joint assessment, ASAS20 response criteria, assessment of laboratory analysis inflammation index (HS-CRP, IgA, ESR), safety index checks (CBC, SGPT, Serum creatinine, HBV-DNA if HbsAg (+), HCV -RNA if HCVAB.

Subjects need to return OPD week 0, accept Anti-HBs, Anti-HBc, HBsAg, Anti-HCV. Subjects required to return to the first outpatient follow 0,20,92 weeks, pulmonary function tests.

Therefore, the subjects in the 92 weeks of the trial, a total need for blood six times, each time for blood about 10 cc. And to assess side effects and adverse events (Adverse Event, AE), serious adverse events (Serious Adverse Event, SAE)

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years old
  • HLA B27 positive
  • X ray examination
  • Clinical symptoms and physical examination, the following three conditions are subject to at least two:
  • i.lower back pain and morning stiffness symptoms persist more than 3 months ii. lumbar activity is restricted iii. chest expansion is restricted
  • Active disease for four weeks or more (continue two examination BASDAI>6, ESR> 28 mm/1 hr and CRP>1 mg/dl)

排除标准

  • pregnant or breast-feeding women
  • patients with active infections
  • highly infectious patients
  • Cancer or precancerous condition of the patient
  • multiple sclerosis

研究组 & 干预措施

NSAIDs(+) and sulfasalazine(+)

Experimental

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine

干预措施: TNF alpha (Biological)

NSAIDs(+) and sulfasalazine(+)

Experimental

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine

干预措施: NSAIDs and sulfasalazine (Drug)

NSAIDs(+) and sulfasalazine(-)

Experimental

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine

干预措施: TNF alpha (Biological)

NSAIDs(+) and sulfasalazine(-)

Experimental

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine

干预措施: NSAIDs and sulfasalazine (Drug)

NSAIDs(-) and sulfasalazine(+)

Experimental

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs

干预措施: TNF alpha (Biological)

NSAIDs(-) and sulfasalazine(+)

Experimental

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs

干预措施: NSAIDs and sulfasalazine (Drug)

NSAIDs(-) and sulfasalazine(-)

Experimental

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) neither NSAIDs nor sulfasalazine

干预措施: TNF alpha (Biological)

结局指标

主要结局

mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)

时间窗: weeks 92

weeks 92 of the spinal injury

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GCRC

Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine

Chung Shan Medical University

研究点 (1)

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