| CTRI Number |
CTRI/2023/06/053443 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of efficacy and safety of oral tofacitinib vs methotrexate in management of moderate to severe chronic plaque psoriasis |
|
Scientific Title of Study
|
A study of Efficacy and safety of oral tofacitinib vs methotrexate in management of moderate to severe chronic plaque psoriasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jahnvi Patel |
| Designation |
First Year PG Resident |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
OPD 35, Ground floor, GCS hospital, GCSMCH and RC, opp D.R.M. Office, near Chamunda bridge, saraspur,Ahmedabad, Gujarat
OPD 35, Ground floor, GCS hospital, GCSMCH and RC, opp D.R.M. Office, near Chamunda bridge, saraspur,Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380025
India |
| Phone |
09426016111 |
| Fax |
|
| Email |
jahnavipatel18510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRanjan Raval |
| Designation |
Professor and Head of the Department |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
Room No 215, B-block ,Resident quarters, GCSMCH and RC, opp D.R.M. Office, near Chamunda bridge, saraspur,Ahmedabad, Gujarat
Room No 215, B-block ,Resident quarters, GCSMCH and RC, opp D.R.M. Office, near Chamunda bridge, saraspur,Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380025
India |
| Phone |
09426016111 |
| Fax |
|
| Email |
ranjanmb@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJahnvi Patel |
| Designation |
First Year PG Resident |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
OPD 35, Ground floor, GCS hospital, GCSMCH and RC, opp D.R.M. Office, near Chamunda bridge, saraspur,Ahmedabad, Gujarat
OPD 35, Ground floor, GCS hospital, GCSMCH and RC, opp D.R.M. Office, near Chamunda bridge, saraspur,Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380025
India |
| Phone |
09426016111 |
| Fax |
|
| Email |
jahnavipatel18510@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [None] |
|
|
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 Jahnvi Patel |
GCS medical College hospital and research centre |
OPD no.35/36,Department of Dermatology, GCS medical College hospital and research centre,Opp DRM office, Naroda road,Ne. Chamunda bridge
Ahmadabad
GUJARAT |
09426016111
jahnavipatel18510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee,GCS Medical College, hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, (2) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methotrexate |
Patient allotted in this arm will be given T. Methotrexate 15 mg once/week for 6 months |
| Intervention |
Tofacitinib |
Patient alloted in this arm will be given T.tofacitinib 5mg BD daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex and age 18-70 years.
2. PASI>12 or BSA>10%
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 or more than 70 years
2. Individuals with severe anaemia, leukopenia(lymphocytes<500 cells/mm3, ANC<500 cells/MM3,Hemoglobin <9g/dl), pre-existing liver diseases, bone marrow pathologies causing cytopenia,
3. Individuals with heavy alcohol consumption (>14 units/week) or heavy smokers.
4. Individuals on concomitant medications such as high dose vitamin D, oral/topical steroids, PUVA, Acitretin, Dapsone, Sulfamethoxazole, Trimethoprim
5. Pregnant and lactating women
6. Patient having pre-existing uncontrolled Diabetes mallitus , Hypertension
7. Patients who have taken any immunosuppressant drugs, homeopathic/herbal medications in last 4 weeks.
8. Patients with malignancies/ history of malignancy.
9. Patients with risk/history of thromboembolism, cardiovascular accidents.
10. Patients with active infection, active/latent tuberculosis.
11. Patients found to have abnormal laboratory parameters that would increase the risk of adverse effect
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in PASI by 75% from baseline at 12 week |
improvement in PASI by 75% from baseline at 12 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in PASI by 100% from baseline
Physicians global assessment
Dermatological Quality of life Index
Safety analysis |
At 24 week |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
01/07/2023 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Methotrexate is the gold standard drug in management of moderate to severe chronic plaque psoriasis but unfortunately is associated with acute toxicity and potentially severe side effects such as cirrhosis. Other available alternative is biologicals but their use is limited due to higher cost. Tofacitinib is a JAK-STAT inhibitor found to be useful in chronic plaque psoriasis. If tofacitinib is found to be non-inferior to methotrexate, another safer and affordable 1st line drug can be used for management of moderate to severe chronic plaque psoriasis. |