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临床试验/CTRI/2020/02/023523
CTRI/2020/02/023523Other不适用

Frequency of Psoriatic Arthritis in Psoriasis patient and their clinical correlates

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月3日最近更新:

试验速览

阶段
不适用
状态
Other
入组人数
200
试验地点
1
主要终点
Frequency of Psoriatic Arthritis among Psoriasis patients

研究概览

简要总结

It is very important to diagnose psoriatic arthritis at an early stage in order to prevent irreversible joint damage and this can affect greatly the quality of living of the patient. Dermatologists are at an excellent seat to diagnose psoriatic arthritis at an early stage in the patients of psoriasis visiting dermatological Out Patient Department(OPD)  Comprehensive data of prevalence and morbidity are still lacking in the Indian subcontinent. It is perhaps underdiagnosed in Indian settings or may be confused with other Rheumatological diseases like Rheumatoid Arthritis and Osteoarthritis. To provide optimal therapy to all patients of Psoriasis Arthritis it is important to know the prevalence, clinical patterns, burden of disease, and economic considerations.

In this study we will analyse the Prevalence of PsA and clinical correlates in the patient population of Psoriasis.

Interviewer –administered Questionnaire (as enclosed) will be used to collect socio-demographic characters like age; religion; education; occupation; residence; relevant history of the disease including onset, duration, progression of Psoriasis, body part invoved aggravating and relieving and associated factors, family history and associated comorbidities; Koebner’s phenomenon; presence of nail Psoriasis; treatment of Psoriasis(steroid therapy).

Patients will be screened for Psoriatic Arthritis using Early Arthritis for Psoriatic Patients (EARP ranging from 0 to 10 where score greater than equal to 3 is considered screening positive)

Severity of the Psoriasis will be assessed by Psoriasis Area and severity score(PASI score ranges from 0 to 72, mild 0 to 3, moderate 3 to 10, and severe >10) and Nail Psoriasis severity Index (NAPSI score ranges from 0 to 160).

Quality of life of Patient with Psoriasis And Psoriatic Arthritis will be assessed using Dermatology Life Quality Index(DLQI ranges from 0 to 30 with score 10 or above indicating severe )  and The Indian version of Health Assessment Questionnaire (HAQ)

Baseline investigations will be done from the Blood sample (a maximum of 10ml) collected from every patient like Complete Blood Count(CBC), Erythrocyte sedimentation Rate(ESR), C- reactive protein(CRP), Liver Function Test(LFT), Kidney function test(KFT), Lipid Profile, Rheumatoid Factor(RF), Random blood Sugar(RBS), Radiography for the affected  joints will performed. 5ml of blood sample collected from every patient will be stored at -80°C for future analysis of specific biomarkers for Psoriatic Arthritis.

An informed consent will be taken from all the patients included in the study.

SCREENING

All patients will be screened for Psoriatic Arthritis using Early Arthritis for Psoriatic Patients (EARP)

All the patients who will be screening positive will be referred to rheumatologist for confirmatory test

CONFIRMATION

Appropriate radiological investigations will be carried out. X rays will be reported by a Radiologist. The final Diagnosis and Classification of Psoriatic Arthritis will be made by the Rheuamatologist on the basis of Classification Criteria for psoriatic Arthritis (CASPAR).

ANALYSIS

The estimated prevalence of Psoriatic Arthritis among Psoriasis patients will be determined. We will also evaluate any significant clinical correlation between the development of Psoriatic Arthritis in Psoriatic Patients and known patient and disease characteristics. We will also study the difference in the Quality of Life in Psoriatic patients with psoriatic Arthritis and those without it

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All subjects with Psoriasis, diagnosed by a Dermatologist on the basis of clinical and histologic examinations are eligible for study.
  • Patients will be recruited from the Out patient Department(OPD), Department of Dermatology, Lok Nayak Hospital, New Delhi.
  • Patients will be invited to take part in the study during their regular visits.

排除标准

  • Subjects that had received a new drug under investigations in the last 30 days.
  • Patients with history of any condition that could interfere in the capacity to understand the requirement of the study.

结局指标

主要结局

Frequency of Psoriatic Arthritis among Psoriasis patients

时间窗: At the end of the study

次要结局

  • clinical correlation of age, gender, site and severity of psoriatic lesion, smoking, Body Mass Index of Psoriasis patients with Psoriatic Arthritis.
  • correlation of Biochemical Parameters of patients of Psoriatic Arthritis among Psoriasis Patients.(At the end of the study)
  • compare the Quality of Life in patients of Psoriasis with Psoriatic Arthritis and those without it.

研究者

申办方类型
Government medical college

研究点 (1)

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