| CTRI Number |
CTRI/2024/11/076709 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing methotrexate and tofacitinib in treatment of psoriasis |
|
Scientific Title of Study
|
Comparison of efficacy and adverse effects of methotrexate (0.3mg/kg/week) vs tofacitinib (5mg twice daily) in chronic plaque psoriasis : A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Bansal |
| Designation |
Junior resident |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8319281107 |
| Fax |
|
| Email |
drsoumyabansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, BHU, Varanasi, 221005, India |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology |
| Address |
Institute of Medical Sciences Banaras Hindu University Varanasi 221005 |
| Type of Sponsor |
Government medical college |
|
|
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 Satyendra Kumar Singh |
Sir Sunderlal Hospital |
Department of dermatology OPD number 207, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH |
9198120582
drsatyendraderma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
methotrexate |
injection methotrexate 0.3mg/kg/week intramuscularly for 4 months |
| Comparator Agent |
tofacitinib |
oral tofacitinib 5mg twice daily for 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All clinically diagnosed cases of psoriasis who give their consent to participate in study with BSA more than 10 percent and/or PASI more than 10. 2. Cumulative methotrexate dose less than 1.5g. 3. Not taking systemic therapy for 1 month and topical therapy for 2 weeks prior to enrolment. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or lactation. 2. History of alcoholism. 3. Taking hepatotoxic or nephrotoxic drugs. 4. Haemoglobin less than 8 gm/dL. 5. TLC less than 4000 cells/mm3. 6. Platelet count less than 1 lakh/mm3. 7. Lymphocytes less than 1500/mm3. 8. Raised SGPT/OT more than or equal to twice the normal limit at baseline or more than equal to thrice the normal limit at follow up. 9. Raised Total bilirubin more than 1.2 or 30percent increase in baseline. 10. Serum creatinine values of more than 1.4 mg/dl at baseline or more than 30 percent increase in baseline at two consecutive visits. 11. Any evidence of active or latent tuberculosis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Psoriasis Area and Severity Index (PASI) 75 |
Psoriasis Area and Severity Index (PASI) 75 at baseline, 2 weekly for 4 weeks, 4 weekly for 12 weeks thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PASI 90, PASI 100 |
PASI 90, PASI 100 at baseline, 2 weekly for 4 weeks, 4 weekly for 12 weeks thereafter |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All patients aged 18 to 65 years diagnosed clinically with chronic plaque psoriasis coming to Dermatology OPD, SSH, BHU those who fulfill the inclusion criteria will be included in the study. All patients will be randomly allocated equally to 2 groups. Group 1 will be given Methotrexate intramuscular injection 0.3mg/kg/week with supportive treatment (proton pump inhibitor, emollient, antihistamines) for 4 months.
Group 2 will be given oral Tofacitinib 5mg twice daily for 4 months with supportive treatment (emollient, antihistamines) for 4 months.
All patients will be followed up every 2 weeks for the first 4 weeks and then every 4 weeks thereafter till 4 months. The affected body surface area, PASI will be recorded along with other relevant baseline clinical investigations and documentation of adverse effects will be done.
|