| CTRI Number |
CTRI/2026/01/102260 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness and safety of tofacitinib alone versus tofacitinib in combination with methotrexate in patients with rheumatoid arthritis” |
|
Scientific Title of Study
|
Efficacy, Safety and Tolerability of
Tofacitinib in addition to Methotrexate
versus Tofacitinib as a Monotherapy in
Patients with Rheumatoid Arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjana Mehta |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara College of Pharmacy |
| Address |
Chitkara college of pharmacy, Rajpura, Punjab
Chitkara University
Patiala
PUNJAB
140401
India |
| Phone |
7986984955 |
| Fax |
|
| Email |
Sanjana@chitkara.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjana Mehta |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara College of Pharmacy |
| Address |
Chitkara college of pharmacy, Rajpura, Punjab
Chitkara University
Patiala
PUNJAB
140401
India |
| Phone |
09736236229 |
| Fax |
|
| Email |
Sanjana@chitkara.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shushank Mahajan |
| Designation |
Junior Research Fellow |
| Affiliation |
Chitkara College of Pharmacy |
| Address |
Chitkara college of pharmacy, Rajpura, Punjab
Chitkara University
department of Pharmacy practice
Patiala
PUNJAB
140401
India |
| Phone |
09736236229 |
| Fax |
|
| Email |
shushank.Mahajan@Chitkara.edu.in |
|
|
Source of Monetary or Material Support
|
| This study is being conducted without any external funding or monetary support.” |
|
|
Primary Sponsor
|
| Name |
Chitkara University |
| Address |
Rajpura-Patiala 140401 |
| Type of Sponsor |
Other [Educational Institute ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr vikas gupta |
Centre for Rheumatology and Arthritis Care |
Room no. 1, Department of Rheumatology, Ludhiana
Ludhiana
PUNJAB |
06239739991
dr_vikas_gupta@dmch.edu |
| Dr Amit Kansal |
Kansal Arthritis and rheumatology Centre of Excellence |
Room no1, Department of Rheumatology, Ludhiana
Ludhiana
PUNJAB |
7508522151
kansal69@reddiff.com |
| Dr Parshant Aggarwal |
Punjab Rheumatology and Immunology Clinic |
Room no 201, Department of Rheumatology,Ludhiana
Ludhiana
PUNJAB |
9876702493
drparshant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chitkara University Punjab |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tofacitinib |
Tofacitinib 5mg BD for 6 months |
| Comparator Agent |
Tofacitinib + Methotrexate |
Tofacitinib + Methotrexate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18-50years
diagnosed With Rheumatoid Arthritis
on methotrexate from last one month |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating women, those who deny to take contraceptives during study period.
2. Patients who deny to provide Consent form. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the DAS28 response of both groups at 24 weeks when compared to baseline |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occurrence of adverse events and serious adverse events (including Change from baseline in clinical laboratory test, Physical Examination and vital sign recorded as adverse events) |
24weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/02/2026 |
| 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="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
|
This study evaluates the efficacy, safety, and tolerability of tofacitinib (a Janus kinase inhibitor) when used in combination with methotrexate (MTX) compared to tofacitinib alone (monotherapy) in patients with rheumatoid arthritis (RA). Results indicate that combining tofacitinib with MTX provides greater clinical improvement in RA symptoms than tofacitinib alone, particularly in patients who had an inadequate response to MTX previously. Both treatment approaches showed a manageable safety profile, though adverse events were slightly more frequent in the combination therapy group. Overall, tofacitinib + MTX was found to be more effective, with acceptable tolerability for most patients. |