| CTRI Number |
CTRI/2024/07/069964 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of tofacitinib in chronic plaque psoriasis |
|
Scientific Title of Study
|
Comparative therapeutic evaluation of oral tofacitinib versus methotrexate in moderate to severe chronic plaque Psoriasis - A hospital based randomized control 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 Rohit Kumar Singh |
| Designation |
Pg resident first year |
| Affiliation |
Dept. of dermatology and venerology , All india institute of medical sciences, gorakhpur |
| Address |
Dept. of dermatology and venerology ,All india institute of medical sciences, gorakhpur , UP , 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8709050740 |
| Fax |
|
| Email |
rohitkrsingh007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Kumar Gupta |
| Designation |
Assistant professor, head of department ,Dept. of dermatology and venerology , aiims gorakhpur |
| Affiliation |
Dept. of dermatology and venerology , All india institute of medical sciences , gorakhpur |
| Address |
Dept. of dermatology and venerology , All india institute of medical sciences, gorakhpur , UP , 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9838844937 |
| Fax |
|
| Email |
dr.sunil_30@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Kumar Singh |
| Designation |
Pg resident first year |
| Affiliation |
Dept. of dermatology and venerology ,All india institute of medical sciences , gorakhpur |
| Address |
Dept. of dermatology and venerology , All india institute of medical sciences, gorakhpur, UP , 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8709050740 |
| Fax |
|
| Email |
rohitkrsingh007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of dermatology and venerology , All india institute of medical sciences , Gorakhpur UP 273008 |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Kumar Singh |
| Address |
Dept. of dermatology and venerology , aiims gorakhpur , UP 273008 |
| Type of Sponsor |
Other [self] |
|
|
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 Rohit Kumar Singh |
Aiims gorakhpur |
Room no.228 , dept. of dermatology and venerology , aiims gorakhpur, 273008 UP
Gorakhpur
UTTAR PRADESH |
8709050740
rohitkrsingh007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet methotrexate |
Tablet methotrexate will be given once weekly in the dose of 0.1-0.3 mg per kg body weight for 16 weeks |
| Intervention |
Tablet tofacitinib |
Tablet tofacitinib 5 mg will be given orally twice daily for 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.patients of 18 to 65 years of age
2.BSA more than 5% and PASI more than 3
3.Patients with well controlled diabetes, hypertension and thyroid disorder |
|
| ExclusionCriteria |
| Details |
1. Patients not consenting to the study.
2. Patient with deranged biochemical profile.
3. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical response as indicated by PASI75 score after 16 weeks of treatment |
16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessing The Dermatology Life Quality Index (DLQI) before , during and after the completion of 16 months.
2. Assessing the changes in Severity of Nail Psoriasis Score (SNAPS) after completion of 16 weeks.
3. Clinical response indicated by change in BSA
|
16 weeks |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
15/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
We are conducting this
randomized controlled trial in the dept. of dermatology and venerology , AIIMS gorakhpur , comparing the safety and efficacy of oral
tofacitinib versus oral methotrexate in patients of moderate to severe chronic
plaque psoriasis over the course of 16 weeks. POPULATION/ PARTICIPANTS: Patients visiting dermatology OPD with diagnosed case of chronic plaque psoriasis diagnosed clinically with age between 18-65 years, satisfying the inclusion criteria, and willing to participate in the study. INCLUSION CRITERIA: patients fulfilling the following criteria will be included in the study 1. Patients between the age group of 18 – 65 yrs. 2. BSA > 5% and PASI score > 3 3. Patients with well controlled diabetes, hypertension and thyroid disorder. EXCLUSION CRITERIA: patients fulfilling the following criteria will be excluded from the study 1. Patients not consenting to the study. 2. Patient with deranged biochemical profile. 3. Pregnant and lactating women. PRIMARY END POINT : 1. Comparison of PASI75 between the two study groups after 16 weeks of treatment. SECONDARY ENDPOINT : 1. Mean improvement in Body Surface Area (BSA) involvement by the end of 16 weeks. 2. Achievement of PASI 90. 3. Improvement in Severity of Nail Psoriasis Score (SNAPS)
|