| CTRI Number |
CTRI/2020/02/023523 [Registered on: 24/02/2020] Trial Registered Prospectively |
| Last Modified On: |
03/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Frequency of arthritis in patients of psoriasis |
|
Scientific Title of Study
|
Frequency of Psoriatic Arthritis in Psoriasis patient and their clinical correlates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumeet Singla |
| Designation |
Associate Professor (Medicine) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Medicine
Room No. 115, First floor,
B L Taneja block
Maulana Azad Medical College
Bahadur Sha Zafar Marg
New Delhi
Central DELHI 110002 India |
| Phone |
|
| Fax |
|
| Email |
sumeetsingla555@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sumeet Singla |
| Designation |
Associate Professor (Medicine) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Medicine
Room No. 115, First floor,
B L Taneja block
Maulana Azad Medical College
Bahadur Sha Zafar Marg
New Delhi
DELHI 110002 India |
| Phone |
|
| Fax |
|
| Email |
sumeetsingla555@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sumeet Singla |
| Designation |
Associate Professor (Medicine) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Medicine
Room No. 115, First floor,
B L Taneja block
Maulana Azad Medical College
Bahadur Sha Zafar Marg
New Delhi
DELHI 110002 India |
| Phone |
|
| Fax |
|
| Email |
sumeetsingla555@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg
New Delhi |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumeet Singla |
Lok Nayak Hospital |
OPD Block, Jawaharlal Nehru Marg Central DELHI |
9810104431
sumeetsingla555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College an Associated Lok Nayak Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L405||Arthropathic psoriasis, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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
|
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| ExclusionCriteria |
| Details |
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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of Psoriatic Arthritis among Psoriasis patients |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
clinical correlation of age, gender, site and severity of psoriatic lesion, smoking, Body Mass Index of Psoriasis patients with Psoriatic Arthritis.
|
At the end of the study |
| 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.
|
At the end of the study |
|
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Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
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
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