NCT05133895

Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study to investigate the treatment response of Tocilizumab on patients with active chronic periaortitis (CP). Methods: patients with a definite or possible diagnosis of CP at acute active stage were enrolled for this study and accepted Tocilizumab monotherapy for 3 months. Endpoints: The primary endpoint is to investigate the treatment response of Tocilizumab; the secondary endpoints include the improvement of inflammatory markers, the frequency of adverse events.

Detailed description

Patients enrolled received intravenous infusions of TCZ (8 mg/kg) at inclusion and then every 4 weeks for at least 3 months. Demographic and clinical features, laboratory findings and imaging examinations were recorded at baseline and during 3-month follow-up. Imaging improvement was converted into the ratio of perivascular soft tissues shrinkage by evaluating 2 dimensions of greatest change on computed tomography (CT) at baseline and after 3 months. Partial remission was defined as obtaining alleviation of symptoms and normalization of inflammatory markers including erythrocyte sedimentation rate (ESR) and high-sensitivity C-reactive protein (hsCRP), with shrinkage of soft tissue mass in imaging \<70%. Further, complete remission was defined as normalization of inflammatory markers accompanied by shrinkage of soft tissue mass ≥70%.

Conditions

• Chronic Periaortitis
• Tocilizumab Monotherapy

Interventions

Type	Name	Description
DRUG	Tocilizumab monotherapy	intravenous infusions of TCZ (8 mg/kg) at inclusion and then every 4 weeks for at least 3 months

Timeline

• Start date: 2020-07-15
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2021-11-24
• Last updated: 2023-03-02

Locations

1 site across 1 country: China