Evaluating Tofacitinib in Knee Osteoarthritis: A Clinical Trial on Safety and Effectiveness

Safety and efficacy of Tofacitinib in osteoarthrtis knee: a randomized placebo-controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090567

Enrollment

100

Registered

2025-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

Intervention1: Tofacitinib: Tofacitinib 11 mg SR for 3 months Control Intervention1: Placebo (Starch capsule): Oral Strach capsule

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with OA knee, Kellgren-Lawrence grade 1 and 2 2. Age more than 50 years 3. Patients willing to participate

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1.To evaluate the efficacy (pain relief, VAS) of Tofacitinib in OA knee patients compared to placeboTimepoint: 1,2,3,6 months	—

Secondary

Measure	Time frame
1. Functional outcome (WOMAC/OKS) 2. HRQOL using EQ5D-5L 3. To look for safety of TofacitinibTimepoint: 1,2,3,6 months	—

Countries

India

Contacts

Public ContactDr Sujit Kumar Tripathy

AIIMS Bhubaneswar

ortho_sujit@aiimsbhubaneswar.edu.in9438884155

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026