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CTRI Number  CTRI/2025/07/090567 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   "Evaluating Tofacitinib in Knee Osteoarthritis: A Clinical Trial on Safety and Effectiveness 
Scientific Title of Study   Safety and efficacy of Tofacitinib in osteoarthrtis knee: a randomized placebo-controlled 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 Sujit Kumar Tripathy 
Designation  Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Room No 17, A-Block Orthopaedic OPD Dept of Orthopaedics AIIMS Bhubaneswar-751019 Odisha, India

Khordha
ORISSA
751019
India 
Phone  9438884155  
Fax    
Email  ortho_sujit@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujit Kumar Tripathy 
Designation  Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Room No 17, A Block Orthopaedics OPD, Dept of Orthopaedics AIIMS Bhubaneswar-751019

Khordha
ORISSA
751019
India 
Phone  9438884155  
Fax    
Email  ortho_sujit@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sujit Kumar Tripathy 
Designation  Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Room No 17, A Block Orthopaedics OPD, AIIMS Bhubaneswar-751019 Odisha, India

Khordha
ORISSA
751019
India 
Phone  9438884155  
Fax    
Email  ortho_sujit@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
A Block, orthopaedics OPD Departmenmt of Orthopaedics AIIMS Bhubaneswar-751019, India 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  A Block, Orthopaedics OPD Sijua, Patrapada Bhubaneswar-751019 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujit Kumar Tripathy  AIIMS Bhubaneswar  Room No 17, A Block Orthopaedic division Sijua, Patrapada Aiginia, Bhubaneswar-751019, India
Khordha
ORISSA 
9438884155

ortho_sujit@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Placebo (Starch capsule)  Oral Strach capsule 
Intervention  Tofacitinib  Tofacitinib 11 mg SR for 3 months 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with OA knee, Kellgren-Lawrence grade 1 and 2
2. Age more than 50 years
3. Patients willing to participate
 
 
ExclusionCriteria 
Details  1. Patients allergic to Tofacitinib
2. Patients on immunosuppressants
3. Patients with inflammatory arthritis
4. Patients with OA knee (Kellgren-Lawrence grade 3 and 4)
5. Patients with skin infections
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the efficacy (pain relief, VAS) of Tofacitinib in OA knee patients compared to placebo  1,2,3,6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Functional outcome (WOMAC/OKS)
2. HRQOL using EQ5D-5L
3. To look for safety of Tofacitinib  
1,2,3,6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   19/07/2025 
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="0"
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 - NO
Brief Summary  
Osteoarthritis (OA) is a problem of the elderly, affecting more than 300 million people worldwide. It is mainly a degenerative process affecting the cartilage of large weight-bearing joints. The knee joint is the most common joint to be affected by primary OA. It is one of the leading causes of disability and morbidity among adults, leading to pain and limitation of range of motion, which in turn affects the quality of life. Due to better health care services, the life expectancy is increasing. As a result of this, the geriatric problems are becoming more common. OA is a mechanical problem arising due to the degradation of cartilage, which in turn leads to skeletal deformities and further leads to cartilage damage. This vicious cycle continues, rendering the joint severely damaged and needing surgical intervention. This damage can be arrested by use of agents that impair this premature breakdown of the cartilage
Tofacitinib is a JAK-Stat pathway inhibitor that inhibits cartilage matrix degradation and prolongs the life of chondrocytes. It also has an anti-inflammatory action. These effects are mainly studied using in vitro models. This drug is well-studied in patients with rheumatoid arthritis and ankylosing spondylitis. But no such study has taken place in human subjects. We wish to conduct this study to look for the efficacy of Tofacitinib in OA knee patients.

 
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