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An observational study of topirazumab in the treatment of Glucocorticoid-Refractory Idiopathic Orbital Inflammation

An observational study of topirazumab in the treatment of Glucocorticoid-Refractory Idiopathic Orbital Inflammation

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066598
Enrollment
Unknown
Registered
2022-12-11
Start date
2020-09-20
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Idiopathic Orbital Inflammation

Interventions

Ttreament Group:TCZ 8 mg/kg every 4 weeks,for 2-6 cycles

Sponsors

Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old, regardless of sex. 2. In patients with Idiopathic Orbital Inflammation who was Glucocorticoid-Refractory 3. Agree to join the group and sign a written informed consent form. 4. Those who have good compliance and agree to take drugs and accept evaluation in accordance with the requirements of the research program.

Exclusion criteria

Exclusion criteria: 1. Complicated with other orbital diseases(TAO ,IgG4). 2. With orbital Inflammation or tuberculosis or positive history of hepatitis B or C liver disease; other systemic inflammatory/ autoimmune conditions. 3. Patients with hematological diseases who are using hormones or similar experimental drugs. 4. Patients who have participated in clinical trials of other drugs or at the same time within 3 months before treatment. 5. Women during pregnancy, lactation, or women of childbearing age who are willing to become pregnant. 6. Allergic constitution or allergic to topirazumab. 7. Alcoholism, drug addicts or other uncontrollable neuropsychiatric disorders are not suitable for drug testing. 8. The researchers believe that it is not appropriate for patients to participate in other conditions of this trial.

Design outcomes

Primary

MeasureTime frame
ocular movement,;

Secondary

MeasureTime frame
orbital pain;IL-6;

Countries

China

Contacts

Public ContactYang Jun Li
liyjun1969@126.com15029226669

Outcome results

None listed

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