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CTRI Number  CTRI/2022/01/039825 [Registered on: 31/01/2022] Trial Registered Prospectively
Last Modified On: 30/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of drug Methotrexate against drugs Methotrexate with Apremilast in Psoriasis disorder 
Scientific Title of Study   Comparative study of oral Methotrexate vs oral Methotrexate along with Apremilast in patients with Moderate to Severe Chronic Plaque Psoriasis  
Trial Acronym  CSOM-MAiP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aanal Patel 
Designation  2nd Year Resident Doctor 
Affiliation  GMERS Medical College & Civil Hospital, Sola 
Address  202, Department of Dermatology, Block A, GMERS Medical College and Civil Hospital, Sola, Besides- New Gujarat High Court, SG Highway, Ahmedabad.
---Same as Address 1---
Ahmadabad
GUJARAT
380060
India 
Phone  9712950119  
Fax    
Email  aanal2607@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krina Patel 
Designation  Professor & Head 
Affiliation  GMERS Medical College & Civil Hospital, Sola 
Address  202, Department of Dermatology, Block A, GMERS Medical College and Civil Hospital,Sola, Besides- New Gujarat High Court, SG Highway, Ahmedabad.
---Same as Address 1---
Ahmadabad
GUJARAT
380060
India 
Phone  09227222221  
Fax    
Email  drkbpatel66@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krina Patel 
Designation  Professor & Head 
Affiliation  GMERS Medical College & Civil Hospital, Sola 
Address  202, Department of Dermatology, Block A, GMERS Medical College and Civil Hospital, Sola, Besides- New Gujarat High Court, SG Highway, Ahmedabad.
---Same as Address 1---
Ahmadabad
GUJARAT
380060
India 
Phone  9227222221  
Fax    
Email  drkbpatel66@gmail.com  
 
Source of Monetary or Material Support  
GMERS Medical College and Civil Hospital, Sola, Ahmedabad. 
 
Primary Sponsor  
Name  GMERS Medical College and CIvil Hospital Sola 
Address  GMERS Medical College and CIvil Hospital, Sola, Besides- New Gujarat High Court, SG highway, Sola, Ahmedabad 
Type of Sponsor  Government medical college 
 
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 
Dr Krina Patel  GMERS Medical College & Civil Hospital-Sola  202-Skin OPD, Block A.
Ahmadabad
GUJARAT 
09227222221

drkbpatel66@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GMERS Medical College and Civil Hospital, Sola, Ahmedabad.  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 
Comparator Agent  Oral Methotrexate   If patient fits in Inclusion criteria, Oral Methotrexate(15mg/week) will be given to patient after Randomization with predecided dose. If needed doses can be increased upto max of 22.5mg/week. Drug will be given for 4 months. And patient will be followed up for another 4 months. 
Intervention  Oral Methotrexate along with oral Apremilast  If patient fits in Inclusion criteria, Oral Methotrexate(15mg/kg) along with oral Apremilast( starting from 10 OD increasing upto 30mg BD) will be given to patient after Randomization with predecided dose. If needed doses of Oral Methotrexate can be increased(upto max of 22.5mg/kg) or decreased or stopped. Drug will be given for 4 months. And patient will be followed up for another 4 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients ready to be part of study and sign ICF.
2. Patient presenting with Moderate to Severe Chronic Plaque Psoriasis according to the Rule of Tens (PASI score >10)
 
 
ExclusionCriteria 
Details  1. Patients who failed to give written consent.
2. In patients in which Methotrexate and/or Apremilast is contraindicated
3. Pregnant women and Lactating Mothers
4. Patients with mild disease (PASI <10)
5. Erythrodermic or pustular psoriasis, predominant scalp or nail involvement
6. Patients who have taken methotrexate continuously or intermittently in more than 2.5gm total dose.
7. Patients with hepatic or renal impairment, cardiac dysfunction, blood dyscrasias or any other systemic comorbidity.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To study the efficacy of oral Methotrexate vs oral Methotrexate with Apremilast in patients with moderate to severe chronic plaque psoriasis
2. To access clinical improvement based on clinical photographs and PASI score
3. To assess the dose requirement of methotrexate in both groups. 
Baseline, then monthly upto 4 months  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the DLQI in both the study groups
2. To study the safety profile of study drugs.
 
Baseline, then monthly upto 4 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/02/2022 
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 Yet Recruiting 
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)?  

Response - NO
Brief Summary  
       Psoriasis is a chronic inflammatory cutaneous disorder, affecting up to 2%-5% of the world population. The major manifestation of psoriasis is erythematous, scaly patches or plaques on the skin that are occasionally pruritic but have a significant impact on patient’s Quality of Life due to chronicity of the disease and frequent remissions and relapses. Psoriasis is a predominantly a T-cell mediated disorder occurring in genetically susceptible individuals, influenced by environmental factors. Methotrexate is a standard, cheaper drug for psoriasis with excellent efficacy but limited safety profile while Apremilast is a newer molecule with excellent safety profile. Comparing the standard drug alone with addition of newer drug will help in identifying better treatment options for psoriasis in terms of efficacy and safety in a disease which requires long term treatment. Methotrexate acts on cell cycle so have higher side effects like Neutropenia, Bone marrow suppression, Liver fibrosis, etc. Apremilast is a biologic which acts via Cyclic AMP pathway. So it has lesser toxicity and side effects than methotrexate. Apremilast can cause increase URTI, Flu-like symptoms in few patients. Apremilast is out of reach for common people because of its prohibiting cost. But nowadays this drug is not that costly. So adding oral Apremilast in Patients with moderate to severe psoriasis, dose of the Methotrexate can be reduced and can be stopped early and low dose oral Apremilast will be continued for a longer time. Whenever disease exacerbates, we can either increase the dose of oral Apremilast or add oral Methotrexate to control the activity. So over long run cumulative dose of Methotrexate can be reduced and toxicity can be decreased.
 
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