| CTRI Number |
CTRI/2026/01/100720 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Tofacitinib, Methotrexate, and their Combination in the Treatment of Rheumatoid Arthritis: A Study on Effectiveness and Safety |
|
Scientific Title of Study
|
A Comparative Study to Evaluate the Efficacy and Safety of Tofacitinib and Methotrexate as Monotherapy versus their Combination in the Management of 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 |
Singh Shashikumar Jitendra |
| Designation |
Junior Resident |
| Affiliation |
Eras Lucknow Medical college and hospital |
| Address |
5th floor Department of Pharmacology Eras Lucknow Medical College and Hospital Sarfaraj ganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9555494381 |
| Fax |
|
| Email |
shakumsin9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Singh Shashikumar Jitendra |
| Designation |
Junior Resident |
| Affiliation |
Eras Lucknow Medical college and hospital |
| Address |
5th floor Department of Pharmacology Eras Lucknow Medical College and Hospital Sarfaraj ganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9555494381 |
| Fax |
|
| Email |
shakumsin9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Singh Shashikumar Jitendra |
| Designation |
Junior Resident |
| Affiliation |
Eras Lucknow Medical college and hospital |
| Address |
5th floor Department of Pharmacology Eras Lucknow Medical College and Hospital Sarfaraj ganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9555494381 |
| Fax |
|
| Email |
shakumsin9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Eras Lucknow Medical College Hospital |
| Address |
Era University Sarfaraj Ganj Lucknow Uttar Pradesh Pin Code 226003 |
| Type of Sponsor |
Private 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 Singh Shashi Kumar Jitendra |
Eras Lucknow Medical College & Hospital |
Eras Lucknow Medical College & Hospital Sarfaraj Ganj Lucknow
Lucknow
UTTAR PRADESH |
9555494381
shakumsin9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Eras Lucknow Medical College & Hospital Lucknow U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
combination of Tofacitinib and Methotrexate |
combination of Tab. Tofacitinib 5mg/day BD and Tab. Methotrexate (Starting dose 5 mg/week). |
| Intervention |
Methotrexate |
Tab. Methotrexate (Starting dose 5 mg/week) |
| Intervention |
Tofacitinib |
Tofacitinib 5mg/day BD |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 or more than 18 years both males and females.
Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR)[A score of greater than or equal to 6/10 confirms the diagnosis of Rheumatoid Arthritis]. |
|
| ExclusionCriteria |
| Details |
Any chronic systemic disease of liver, kidney, lungs and gastrointestinal tract.
Other joint diseases (e.g. Osteoarthritis, Gout, Ankylosing Spondylitis)
Severely immuno-compromised patient.
Pregnant or breastfeeding women.
Patient having contraindication for methotrexate(e.g. chronic liver disease, Bone marrow suppression, Active infections, Severe renal impairment). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of treatment evaluated by End Study Investigation and ACR20/ACR50/ACR70 response evaluation. |
4 Wk 8 Wk 12 Wk 16 Wk 20 Wk and 24 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="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
|
This Observational trial is being done to evaluate the efficacy and safety of Tofacitinib and Methotrexate as mono-therapy versus their combination, in the management of Rheumatoid Arthritis for post graduation thesis submission for the department of Pharmacology. |