跳至主要内容
临床试验/NCT04139954
NCT04139954Unknown不适用

Observational Registry (BioSTaR) Including Demographic and Clinical Data of Patients Diagnosed With Rheumatoid Arthritis and Spondyloarthritis Using a Biological and Targeted Synthetic Disease Modifying Drug

Turkish League Against Rheumatism14 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,400
试验地点
14
主要终点
Disease activity-SpA2

研究概览

简要总结

In this study, investigators aimed to observe the examination findings, laboratory findings and drugs used in routine polyclinic controls of the participants using biological and targeted synthetic disease-modifying antirheumatic drug (DMARD) and the doses and side effects of these drugs. The aim of this registry is to evaluate the real-life data of participants receiving these medications. Analysis of treatment follow-up, drug changes, causes of change, treatment-related paradoxic / immune reactions, compliance with adult vaccination programs, nutritional profiles, presence of metabolic syndrome, fertility status, pregnancy outcomes, and vitamin D levels will be recorded in the outpatient clinic. Rheumatoid Arthritis Impact of Disease, Psoriatic Arthritis Impact of Disease (RAID and PSAID indexes), Work Productivity and Activity Impairment Questionnaire (WPAI), drug compliance, central sensitization and fall risk will be evaluated with verbal evaluation forms performed at policlinic controls in patients with spondyloarthritis and rheumatoid arthritis. It is planned to conduct scientific analyzes and publish on various subjects from the recorded information on this registration system.

Patients using biological and targeted synthetic DMARD treatments are closely monitored and evaluated in many ways due to the risk profiles and various characteristics of the drugs. With this registry system, it is aimed to evaluate the real-life data of the participants using these drugs. Real-life data are very valuable in monitoring the disease and the drugs.

The study is observational and there is no expected risk since no intervention is planned.

详细描述

In this study, investigators aimed to observe the examination findings, laboratory findings and drugs used in routine polyclinic controls of the participants using biological and targeted synthetic disease-modifying antirheumatic drug (DMARD) and the doses and side effects of these drugs. The aim of this registry is to evaluate the real-life data of participants receiving these medications. Analysis of treatment follow-up, drug changes, causes of change, treatment-related paradoxic / immune reactions, compliance with adult vaccination programs, nutritional profiles, presence of metabolic syndrome, fertility status, pregnancy outcomes, and vitamin D levels will be recorded in the outpatient clinic. Rheumatoid Arthritis Impact of Disease, Psoriatic Arthritis Impact of Disease (RAID and PSAID indexes), Work Productivity and Activity Impairment Questionnaire (WPAI), drug compliance, central sensitization and fall risk will be evaluated with verbal evaluation forms performed at policlinic controls in patients with spondyloarthritis and rheumatoid arthritis. It is planned to conduct scientific analyzes and publish on various subjects from the recorded information on this registration system.

Patients using biological and targeted synthetic DMARD treatments are closely monitored and evaluated in many ways due to the risk profiles and various characteristics of the drugs. With this registry system, it is aimed to evaluate the real-life data of the participants using these drugs. Real-life data are very valuable in monitoring the disease and the drugs.

Planned studies are:

ROMATOID ARTHRITIS CLINICAL DEMOGRAPHIC ASSESSMENT / DISEASE EFFECT / DRUGS

  • SPONDYLOARTHRITIS CLINICAL DEMOGRAPHIC EVALUATION / DISEASE EFFECT / DRUGS
  • COMORBIDITY IN ROMATOID ARTHRITIS
  • COMORBIDITY IN SPONDYLOARTHRITIS
  • RE ACTIVITATION AND SAFETY MONITORING IN VIRAL HEPATITIS
  • TREATMENT PARADOXIC / IMMUNE REACTIONS (SYSTEMIC AUTOIMMUNE, ARTHRITIS, HEMATOLOGIC, NEUROLOGIC, PULMONARY, OPHTHALMOLOGICAL, INFLAMMATORY BOWEL DISEASE, LIVER, CUTANEOUS, OTHER)
  • WORK FORCE LOSS IN AXIAL SPONDYLOARTHRITIS
  • WORK FORCE LOSS IN PSORIATIC ARTHRITIS
  • WORK FORCE LOSS IN ROMATOID ARTHRITIS
  • PREGNANCY / FERTILITY OUTCOMES
  • TUBERCULOSIS MONITORING
  • DRUG SWITCH ANALYSIS
  • THROID DISEASE IN EARLY AND ESTABLISHED ROMATOID ARTHRITIS (AUTOIMMUNE THROIDITIS, MALIGNITY etc)
  • TREATMENT COMPLIANCE IN RHEUMATIC DISEASES
  • ADULT IMMUNIZATION PROGRAM IN RHEUMATIC DISEASES
  • METABOLIC SYNDROME ASSESSMENT
  • CARDIOVASCULAR RISK ASSESSMENT
  • FALL / FRACTURE AND RELATED VARIABLES IN RHEUMATIC DISEASES
  • VITAMIN D STATUS IN RHEUMATIC DISEASES
  • CENTRAL SENSITIZATION AND PAIN IN ROMATOID ARTHRITIS AND SPONDYLOARTROPATHIES AND RELATED VARIABLES The study is observational and there is no expected risk since no intervention is planned.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Clinical diagnosis with rheumatoid arthritis or spondyloarthritis Receiving biological or targeted synthetic DMARD treatment

排除标准

  • Aged under 18 years old

结局指标

主要结局

Disease activity-SpA2

时间窗: 24 weeks

BASDAI score will be calculated

Disease activity RA

时间窗: 24 weeks

DAS 28 score will be calculated (Sensitive and swollen joints, VAS pain score, patient's global assessment and CRP / ESH values will be used for scoring)

Disease activity- SpA1

时间窗: 24 weeks

ASDAS score will be calculated (Sensitive and swollen joints, VAS pain score, patient's global assessment and CRP / ESH values will be used for scoring)

次要结局

未报告次要终点

研究者

发起方
Turkish League Against Rheumatism
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Gül Yurdakul

Clinical Associate Professor (Fatma Gül Yurdakul)

Turkish League Against Rheumatism

研究点 (14)

Loading locations...

相似试验

Observational Registry of Patients With Rheumatoid... | 临床试验