Skip to content

Efficacy and Safety of IL-1 Inhibitors Combined with Needle Knife Mirror in Treating Gouty Arthritis

Efficacy and Safety of IL-1 Inhibitors Combined with Needle Knife Mirror in Treating Gouty Arthritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127190
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

gout

Interventions

Firsekibart Treatment Group:Firsekibart

Sponsors

HuNan University of Medicine General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the gout classification criteria developed by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) in 2015. 2. Patients with significant knee symptoms (presence of swelling, tenderness, or limited joint function). 3. Patients aged 18–80 years. 4. Patients who agree to participate in this study and voluntarily sign the informed consent form. 5. IL-1 inhibitors for acute attacks of gouty arthritis in adults who meet at least one of the following criteria: Contraindication, intolerance, or inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) and/or colchicine; Patients who are unsuitable for repeated use of systemic corticosteroids. 6. Indications for needle-knife arthroscopy: (1) Recurrent acute gout attacks with poor response to medical treatment, presenting as frequent redness, swelling, heat, and pain. (2) Subcutaneous or intra-articular tophaceous deposition of gouty crystals, presenting as indurated nodules. (3) Persistent joint swelling, hypertrophic proliferative synovitis, and recurrent joint effusion that does not resolve after repeated aspiration. (4) Limited joint mobility, catching sensation during flexion/extension, joint stiffness, and adhesions. (5) Extensive intra-articular deposition of urate crystals with hyperemic and proliferative synovium.

Exclusion criteria

Exclusion criteria: 1. Patients with severe primary diseases of the cardiovascular, cerebrovascular, digestive, or hematopoietic systems, as well as those with psychiatric disorders or impaired consciousness. 2. Patients with comorbid other forms of arthritis (e.g., rheumatic arthritis, rheumatoid arthritis). 3. Patients with severe trauma, or those who are in the perioperative, intraoperative, or postoperative recovery period. 4. Patients with a history of addiction to psychotropic drugs, substance abuse, alcohol abuse, or sensory disorders. 5. Pregnant or lactating women. 6. Other conditions that the investigator considers inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
SF-36 Quality of Life Score;Lysholm Knee Function Score;

Secondary

MeasureTime frame
Infection events;C-reactive protein (CRP);Adverse Events (AE);Serious Adverse Event (SAE);Laboratory safety parameters;Gout recurrence within 24 weeks;Surgery?related complications;Pain Visual Analog Scale (VAS);

Countries

China

Contacts

Public ContactLiang Song

HuNan University of Medicine General Hospital

18674558206@163.com+86 745 231 0091

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026