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CTRI Number  CTRI/2019/01/017362 [Registered on: 31/01/2019] Trial Registered Prospectively
Last Modified On: 28/01/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the effects of Apremilast and Methotrexate in the treatment of patients with psoriasis 
Scientific Title of Study   An open-labelled randomised comparative evaluation of therapeutic efficacy and safety of Apremilast versus Methotrexate in the treatment of patients with Chronic plaque psoriasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RATHIPRIYADHARSHINI R 
Designation  DOCTOR 
Affiliation  Chettinad Hospital and Research institute 
Address  Department of Dermatology, Chettinad hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam
No.7E,Kulaal street,Pattukkottai, Thanjavur dt-614601
Kancheepuram
TAMIL NADU
603103
India 
Phone  8870705609  
Fax    
Email  rathiii5893@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SRINIVASAN M S 
Designation  Professor and Head 
Affiliation  Chettinad Hospital and Research institute 
Address  Department of Dermatology, Chettinad hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  044-47428101  
Fax    
Email  srinimeghna@gmail.com  
 
Details of Contact Person
Public Query  
Name  RATHIPRIYADHARSHINI R 
Designation  DOCTOR 
Affiliation  Chettinad Hospital and Research institute 
Address  Department of Dermatology, Chettinad hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam
No.7E,Kulaal street,Pattukkottai, Thanjavur dt-614601
Kancheepuram
TAMIL NADU
603103
India 
Phone  8870705609  
Fax    
Email  rathiii5893@gmail.com  
 
Source of Monetary or Material Support  
Chettinad hospital and research institute 
 
Primary Sponsor  
Name  RATHIPRIYADHARSHINI R 
Address  Dept of Dermatology, Chettinad hospital and research institute, Kelambakkam-603103 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
RATHIPRIYADHARSHINI  Chettinad hospital and research institute  Out Patient Department No.16, A-Block, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU 		 8870705609

rathiii5893@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chettinad Academy of Research and Education-Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Apremilast  oral phosphodiestrase-4 inhibitor.Approved by FDA in 2014 and by Central Drugs Standard Control Organization of India in 2017 for plaque psoriasis 
Comparator Agent  METHOTREXATE  Folate antagonist used in the treatment of psoriasis for decades 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Those With chronic plaque psoriasis involving >10%BSA
Those who sign the written consent form prior to participation in the study 
 
ExclusionCriteria 
Details  pregnancy
lactation
abnormalities in LFT,RFT,CBC
hypertension and diabetes
active tuberculosis/ HIV infection
Hypersensitivity to the drugs
Those on immunosuppresive medications
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in PASI[Psoriasis Area and Severity Index] more than 75% from baseline  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in PASI[ PsoriasisArea and Severity Index]   3 weeks,9 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   04/02/2019 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Psoriasis is a common, chronic inflammatory,immune mediated, hyperproliferative condition affecting primarily the skin. It is associated with significant reduction in the quality of life. There are several modalities of treatment available but none is satisfactory in acheiving significant clearance of lesions. Apremilast is the new orally active Phosphodiestrase-4 inhibitor found to be effective in treatment of psoriasis with negligible adverse effects and also eithout any need for rotine monitoring of blood parameters. Methotrexate is a well-known drug in the treatment of psoriasis for years. Eventhough there is reduction in the morbidity, it is associated with frequent side effects and patient dissatisfaction. This study is to evaluate the efficacy and safety of Apremilast in our setting and to compare the same with the conventionally used Methotrexate in the treatment of Chronic Plaque Psoriasis. 
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