Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis

NCT05133895 | Completed

• 1 other identifier: Tocilizumab for Periaortitis
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Periaortitis; Tocilizumab Monotherapy

Keywords

chronic periaortitis; Tocilizumab; treatment response; complete remission; partial remission

Outcome Measures

Primary Outcomes (1)

• treatment response

  the rate of partial remission and complete remission after 3-month TCZ monotherapy

  three months

Secondary Outcomes (2)

• the frequency of treatment related adverse events

  three months

• the improvement of inflammatory markers

  three months

Study Arms (1)

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.

Drug: Tocilizumab monotherapy

Interventions

Tocilizumab monotherapy DRUG

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

Tocilizumab monotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic periaortitis (CP) is characterized by the presence of mass that develops around the thoracic aorta, abdominal aorta or iliac arteries, with predominance in males of middle and elderly age.

You may qualify if:

• adults ≥ 18 years of age at time of informed consent;
• meet clinical diagnostic criteria including (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;
• at active stage: clinical symptoms or organ involvement; a higher level of ESR and CRP than normal;

You may not qualify if:

• Secondary forms of CP related to drugs, infections, malignancies, Erdheim-Chester disease or other autoimmune diseases were excluded.
• Combined with other autoimmune diseases.
• Known immunodeficiency disorder.
• Pregnancy, lactation, or planning to become pregnant within 6 months of the test.
• Positive test for, or prior treatment for, hepatitis B or HIV infection. A positive test for hepatitis B is detection of hepatitis B surface antigen (HBsAg) or HBV-DNA.
• Evidence of active tuberculosis (TB), including Chest X-ray and PPD.
• Severe abnormal liver function or cardiac insufficiency.
• Any reason the investigator think that should not attend this trial.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Yunyun Fei

Beijing, China

Location

MeSH Terms

Conditions

Retroperitoneal Fibrosis; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Progression; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: November 24, 2021
• Study Start: July 15, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

CN (1)