Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 15
- 主要终点
- Percentage of Participants Who Developed Psoriatic Arthritis (PsA)
研究概览
简要总结
Psoriatic Arthritis (PsA) is a comorbidity that affects a significant proportion of participants with moderate or severe psoriasis. The purpose of this study was to describe the profile of patients with moderate or severe plaque psoriasis (Ps) in Colombia and to evaluate adalimumab efficacy and safety profile.
详细描述
Psoriasis is a chronic inflammatory disease affecting 1% to 3% of the population worldwide. A significant portion (5%-40%) of participants with psoriasis develop PsA, a chronic inflammatory arthritis that causes progressive joint damage, reduced functionality and increased mortality risk. Skin disease typically manifests before arthritis in more than 80% of PsA participants, and psoriasis symptoms usually precede joint symptoms by an average of 10 years. Participants with psoriasis who have comorbid PsA incur substantially increased cost of care and experience greater impairment of physical functioning and quality of life compared with participants with psoriasis alone.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Participant has a documented clinical diagnosis of psoriasis, as determined by participant interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator
- •Participant has indication of psoriasis systemic therapy
- •If female, participant is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
- •Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
- •Contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration
- •A vasectomized partner
- •Total abstinence from sexual intercourse
- •Able and willing to give written informed consent and comply with the requirements of the study protocol
排除标准
- •Participants who have active infections
- •Participants enrolled in another study or clinical trial
- •Any condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or participants to an unacceptable risk
- •History of active tuberculosis (TB), histoplasmosis or listeriosis
结局指标
主要结局
Percentage of Participants Who Developed Psoriatic Arthritis (PsA)
时间窗: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
A participant is said to have PsA if they meet the following criteria: 1. PsA defined by a rheumatologist; or 2. A participant with inflamed joints \>0 and CASPAR score \>=3; or 3. Participant meeting at least one of the two previous definitions.
Percentage of Participants Who Developed Signs or Symptoms of PsA
时间窗: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Signs or symptoms were defined as mentioning at the rheumatologist visit any joint symptoms prior to or during the visit or a total number of inflamed joints greater than 0.
次要结局
- Mean Time to First Occurrence of PsA Signs or Symptoms(Baseline up to Visit 4 (month 12))
- Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score(At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12))
- Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA(Baseline up to Visit 4 (month 12))
- Mean Change in Quality of Life (QoL)(At Baseline, Visit 3 (month 6) and Visit 4 (month 12))
- Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score(At Baseline, Visit 3 (month 6) and Visit 4 (month 12))
- Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist(At Baseline, Visit 3 (month 6) and Visit 4 (month 12))
- Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero(At Baseline, Visit 3 (month 6) and Visit 4 (month 12))
- Percentage of Participants With Joint Symptoms(At Baseline, Visit 3 (month 6) and Visit 4 (month 12))
- Incidence Rate of PsA Since Psoriasis Diagnosis(Baseline up to Visit 4 (month 12))
- Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50%(At Baseline, Week 24, and Week 48)