| CTRI Number |
CTRI/2024/08/072427 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Treatment out come of psoriasis with Oral Methotraxate versus Oral Tofacitinib |
|
Scientific Title of Study
|
Effectiveness and Safety of Oral Methotrexate versus Oral tofacitinib in the Treatment of Chronic Plaque Psoriasis-A 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 |
Rishana N |
| Designation |
Post graduate |
| Affiliation |
SRM Medical College Hospital And Research Centre |
| Address |
Room number-15,Department of Dermatology, Venereology and Leprosy (DVL),
SRM Medical College Hospital And Research Centre, SRM University Campus, Kattankulathur.
Room number-15,Department of Dermatology, Venereology and Leprosy (DVL),
SRM Medical College Hospital And Research Centre, SRM University Campus, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7867001210 |
| Fax |
|
| Email |
rishanamohamed786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramachandran Ramakrishnan |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital And Research Centre |
| Address |
Room number-15,Department of Dermatology, Venereology and Leprosy (DVL),
SRM Medical College Hospital And Research Centre, SRM University Campus, Kattankulathur.
Room number-15,Department of Dermatology, Venereology and Leprosy (DVL),
SRM Medical College Hospital And Research Centre, SRM University Campus, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840458783 |
| Fax |
|
| Email |
drram.srkn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rishana N |
| Designation |
Post graduate |
| Affiliation |
SRM Medical College Hospital And Research Centre |
| Address |
Room number-15,Department of Dermatology, Venereology and Leprosy (DVL),
SRM Medical College Hospital And Research Centre, SRM University Campus, Kattankulathur.
Room number-15,Department of Dermatology, Venereology and Leprosy (DVL),
SRM Medical College Hospital And Research Centre, SRM University Campus, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7867001210 |
| Fax |
|
| Email |
rishanamohamed786@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital And Research Centre,
Kattankulathur,
kancheepuram,
Tamilnadu- 603203,
India |
|
|
Primary Sponsor
|
| Name |
Rishana N |
| Address |
Room number-15,Department of Dermatology, Venereology and Leprosy (DVL),
SRM Medical College Hospital And Research Centre, SRM University Campus, Kattankulathur. |
| 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 |
| Rishana N |
SRM Medical College Hospital And Research Centre |
Department of Dermatology, Venereology and Leprosy (DVL),
SRM Medical College Hospital And Research Centre, SRM University Campus, Kattankulathur
Kancheepuram
TAMIL NADU |
7867001210
rishanamohamed786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Students, SRM Medical College Hospital |
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 |
| Intervention |
Effectiveness and safety of Oral Methotrexate and Oral tofacitinib in the Treatment of Chronic Plaque Psoriasis .
|
GROUP A – Oral MTX 7.5mg weekly once and T.FOLIC ACID 5mg od to be given on all days except the day of MTX administration.
GROUP B – T.Tofacitinib 5mg twice daily
Will be given for a period of 20 weeks for each group.
Patient will be reviewed once in 4 weeks and PASI(Psoriasis area and severity index), NAPSI(NAIL PSORIASIS SEVERITY INDEX) and ACR(American college of Rheumatology) will be noted in baseline and followed up for every week.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Chronic plaque psoriasis with PASI more than 10.
Patient with nail psoriasis.
Patient with Psoriatic arthritis. |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation.
Females and males who were planning to have a child and not willing for using contraception.
Systemic therapy taken for psoriasis in the past 4 weeks before enrolling into the study.
Topical therapy taken for psoriasis in past 2 weeks before enrolling into the study.
Acute or chronic liver disease or renal disease/ uncontrolled hypertension/ uncontrolled Diabetes mellitus.
known allergy to any of the study drugs.
Active infection such as Tuberculosis, HIV, Hepatitis B and C.
History of disseminated herpes zoster or herpes simplex or recurrent localized dermatomal herpes zoster.
Patient on any other immunosuppressants.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PASI50
PASI75
PASI90
NAPSI
ACR20
ACR50
ACR70 |
0,4TH,8TH,12TH,16TH,20TH WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PATIENT SATISFACTION SCORE
PHYSICIAN GLOBAL ASSESSMENT SCORE |
20TH WEEK |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 4 |
|
Date of First Enrollment (India)
|
23/08/2024 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rishanamohamed786@gmail.com].
- For how long will this data be available start date provided 10-07-2024 and end date provided 29-08-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients will be randomised into 2 groups – group A and group B using a random sequence generated by Randomization software of Research randomizer.org. Pre treatment Investigations – CBC with ESR , CRP , Liver fuction test , Renal function test , Viral serology , FBS , HbA1c ,PPBS ,Sr. electrolytes, FLP , CXR – PA view, Tuberculin skin test , ECG, Urine routine and Joint x ray ,screening ECHO. GROUP A – Oral MTX 7.5mg weekly once and T.FOLIC ACID 5mg od to be given on all days except the day of MTX administration. GROUP B – T.Tofacitinib 5mg twice daily. Antihistamine will be administered to the patients other than the study drugs, for both the groups. In both groups baseline PASI score , NAPSI score , ACR score, PGA score and Patient satisfaction score for 0,4th,8th,12th,16th and 20th weeks and clinical photographs will be taken. |