Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis

Completed

• Conditions: Chronic Periaortitis; Tocilizumab Monotherapy
• Interventions: Drug: Tocilizumab monotherapy

• Registration Number: NCT05133895
• Lead Sponsor: Peking Union Medical College Hospital

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.

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%.

Study Timeline

• Study Start: 2020-07-15
• Study First Submitted: 2021-11-14
• Study First Submitted QC: 2021-11-14
• Study First Posted: 2021-11-24
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. adults ≥ 18 years of age at time of informed consent;
2. 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;
3. at active stage: clinical symptoms or organ involvement; a higher level of ESR and CRP than normal;

Exclusion Criteria

1. Secondary forms of CP related to drugs, infections, malignancies, Erdheim-Chester disease or other autoimmune diseases were excluded.
2. Combined with other autoimmune diseases.
3. Known immunodeficiency disorder.
4. Pregnancy, lactation, or planning to become pregnant within 6 months of the test.
5. 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.
6. Evidence of active tuberculosis (TB), including Chest X-ray and PPD.
7. Severe abnormal liver function or cardiac insufficiency.
8. Any reason the investigator think that should not attend this trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tocilizumab monotherapy	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 Measures

Name	Time	Method
treatment response	three months	the rate of partial remission and complete remission after 3-month TCZ monotherapy

Secondary Outcome Measures

Name	Time	Method
the frequency of treatment related adverse events	three months	adverse events caused by TCZ during 3-month follow-up.
the improvement of inflammatory markers	three months	including erythrocyte sedimentation rate (ESR) and high-sensitivity C-reactive protein (hsCRP).

Trial Locations

Locations (1)

Yunyun Fei; 🇨🇳 Beijing, China