Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (Complete - AS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 722
- 试验地点
- 56
- 主要终点
- Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis
研究概览
简要总结
The current study will assess the real - life effectiveness of adalimumab in the management of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of extra-articular manifestations.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult >= 18 years old
- •Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
- •Active Ankylosing Spondylitis as per the judgment of the treating physician
- •Inadequate response or non tolerant to current NSAID (Nonsteroidal Anti-Inflammatory Drug) or DMARD (Disease-Modifying Anti Rheumatic Drug) based treatment for AS
排除标准
- •Currently participating in another prospective study including controlled clinical trials and observational studies
- •Patient cannot or will not sign informed consent
- •Stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated
- •Previous treatment with anti-TNF (Tumor Necrosis Factor) or other biologic agent
- •Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of AS
结局指标
主要结局
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis
时间窗: Every 3 months up to 6 months, then every 6 months up to 24 months
Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Inflammatory Bowel Disease
时间窗: Every 3 months up to 6 months, then every 6 months up to 24 months
Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Enthesitis of the Heel: Achilles Tendon and Plantar Fascia
时间窗: Every 3 months up to 6 months, then every 6 months up to 24 months
Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Psoriasis
时间窗: Every 3 months up to 6 months, then every 6 months up to 24 months
Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe))
次要结局
- PASQ (Psoriasis and Arthritis Screening Questionnaire)(Every 3 months up to 6 months, then every 6 months up to 24 months)
- BASDAI (Bath AS Disease Activity Index)(Every 3 months up to 6 months, then every 6 months up to 24 months)
- BASFI (Bath AS Functional Assay)(Every 3 months up to 6 months, then every 6 months up to 24 months)