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Tofacitinib vs oral non-steroidal anti-inflammatory drugs in the treatment of inflammatory knee osteoarthritis: a randomized, open-label, multicenter, controlled study

Tofacitinib vs oral non-steroidal anti-inflammatory drugs in the treatment of inflammatory knee osteoarthritis: a randomized, open-label, multicenter, controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070156
Enrollment
Unknown
Registered
2023-04-04
Start date
2023-04-01
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

inflammatory osteoarthritis

Interventions

intercention group:Addition of Topoteb to the original treatment
control group:Oral anti-inflammatory and analgesic drugs

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged over 40 years; 2. The patients should fufill the 1995 ACR osteoarthritis classification criteria; 3. Knee joint swelling, tenderness and increased skin temperature as judged by physicians; 4. Poor response to conventional anti-inflammatory and analgesic drug treatment for 4 weeks; 5. Peripheral erythrocyte sedimentation rate is higher than 28mm/h or high sensitive C reactive protein is over 8mg/L; 6. B-ultrasound or knee MRI clear evidence of synovitis.

Exclusion criteria

Exclusion criteria: 1. IV level of K-L evaluation of knee in X-ray; 2. High level of rheumatoid factor or anti-CCP level(over 2 fold); 3. positive of ANA; 4. Patients with gout, infection or SpA; 5. Positive of TB test; 6. Positive of HBV infection; 7. There is a history of tumor in the past; 8. Patients who are pregnant or breastfeeding; 9. Allergy history of tofacitinib; 10. Abnormal of liver or renal function; 11. The patient had an intra-articular injection of glucocorticoid in the past 12 weeks; 12. Other situation inappropriate to use tofacitinib that decided by researchers.

Design outcomes

Primary

MeasureTime frame
OMERACT-OARSI;Erythrocyte sedimentation rate;hsCRP;

Secondary

MeasureTime frame
Untralsound evaluation of synovitis;MRI Synovitis Score;

Countries

China

Contacts

Public ContactShengming Dai

Shanghai Sixth People's Hospital

dai_sm@126.com+86 21 24056467

Outcome results

None listed

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