Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis

Conditions

• Chronic Periaortitis
• Tocilizumab Monotherapy

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 15, 2020

Status verified

Mar 2023

Primary completion

Dec 30, 2022

Completion

Dec 30, 2022

Study Design

Enrollment

12 participants (actual)

Arms

• Arm: Tocilizumab monotherapy
  Patients with a definite or possible diagnosis of CP at acute active stage were enrolled for this study. Clinical diagnostic criteria consist of: (1) imaging findings show perivascular soft tissue density mass surrounding thoracic aorta, abdominal aorta or iliac arteries; (2) histopathological findings show fibrous tissue with chronic inflammatory infiltrate comprised of lymphocytes, plasma cells and macrophages (Neutrophils and granulomas are rare). Patients who satisfied (1) but without histopathological examination were perceived as possible CP. Secondary forms of CP related to drugs, infections, malignancies, Erdheim-Chester disease or other autoimmune diseases were excluded. Patients enrolled received intravenous infusions of TCZ (8 mg/kg) at inclusion and then every 4 weeks for at least 3 months.

Primary Outcome Measure

treatment response [ Time Frame: three months ]