FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/03/003505 [Registered on: 21/03/2013] Trial Registered Retrospectively
Last Modified On: 26/09/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare effectiveness of methotrexate-pioglitazone combination against methotrexate alone in patients of psoriasis, a skin disorder  
Scientific Title of Study   Study of effectiveness of methotrexate-pioglitazone combination compared to methotrexate alone in patients of plaque psoriasis with an attempt to revisit some relevant immunological perspectives 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Indranil Banerjee 
Designation  Post Doctoral trainee in DM(Clinical Pharmacology) 
Affiliation  School of Tropical Medicine, Kolkata 
Address  Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, 108, C.R. Avenue, Kolkata

Kolkata
WEST BENGAL
700073
India 
Phone  9432184197  
Fax    
Email  dronineo@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Santanu Kumar Tripathi 
Designation  Professor and Head 
Affiliation  School of Tropical Medicine, Kolkata 
Address  Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, 108, C.R. Avenue, Kolkata

Kolkata
WEST BENGAL
700073
India 
Phone  9230566771  
Fax    
Email  tripathi.santanu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Indranil Banerjee 
Designation  Post Doctoral trainee in DM(Clinical Pharmacology) 
Affiliation  School of Tropical Medicine, Kolkata 
Address  Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, 108, C.R. Avenue, Kolkata


WEST BENGAL
700073
India 
Phone  9432184197  
Fax    
Email  dronineo@yahoo.co.in  
 
Source of Monetary or Material Support  
School of Tropical Medicine 
 
Primary Sponsor  
Name  School of Tropical Medicine 
Address  Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata-700073 
Type of Sponsor  Research institution 
 
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 
Indranil Banerjee  Room no. 19, Department of Clinical and Experimental Pharmacology  School of Tropical Medicine, 108 C.R.Avenue, Kolkata-700073
Kolkata
WEST BENGAL 		 9432184197

dronineo@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, School of Tropical Medicine, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients of either gender, age between 18 years and 65 years clinically diagnosed as plaque psoriasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Methotrexate and pioglitazone combination therapy   Methotrexate 15 mg once weekly for 12 weeks and pioglitazone 15 mg once daily for 12 weeks both given orally 
Comparator Agent  Methotrexate monotherapy  Methotrexate 15 mg once weekly monotherapy by oral route for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients between 18 -65 years of age (both inclusive) with clinical diagnosis of plaque psoriasis as determined through clinical examination.
2. Patient should be a candidate for systemic therapy
3. PASI (Psoriasis Area and Severity Index) score of ≥ 12 at the Baseline visit.
4. Females who were postmenopausal or tubectomised or have completed their family size and are willing to maintain contraception 1 month before, during and 1 month after completion/stopping of treatment.
5. Sexually active male subjects are able to participate in the study if they use effective contraception during the study and 3 months after study completion.
6. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, and 12-lead electrocardiogram (ECG) performed at Screening.
7. Able and willing to give written informed consent and to comply with the requirements of this study protocol.
 
 
ExclusionCriteria 
Details  • Pregnant or lactating women.
• Any abnormalities in renal function, cardiovascular disease, respiratory disease or neuropsychiatric illness.
• Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP >1.5 times the upper limit of normal), viral hepatitis or cirrhosis.
• History of excessive alcohol consumption.
• Severe anemia, leucopenia or thrombocytopenia.
• History of active infectious disease or immune system deficiency including AIDS.
• History of intolerance/hypersensitivity to methotrexate.
• Subjects who have used any investigational drugs within 4 weeks of Screening or are participating in other clinical studies
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•The change in PASI (Psoriasis Area and Severity Index) scores of the patients as measured at baseline and at week 12.   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The change in Physicians Global Assessment (PGA) Score of the patients as measured at baseline and at week 12.
 		 12 weeks 
Serum level of certain cytokines in patients at baseline and at 12 weeks  12 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/01/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Psoriasis is a chronic, inflammatory, immune mediated skin disorder.The present piece of work aims to evaluate the effectivenessof methotrexate -pioglitazone combination versus methotrexate in plaque psoriasis patients.Besides this, an effort will be made to elucidate impact of the abovementioned two treatment regimens on some selected immunologic parameters. An openlabel, parallel design, randomized clinical trial will be conducted at the Calcutta School of Tropical Medicine to address the abovementioned study objectives.Effectiveness of the two treatment regimens will be assessed in terms of relative changes in efficacy, safety and quality of life in either group measured at baseline and after 12 weeks of treatment.
 
Close