| 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
|
|
|
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
|
|
|
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.
|