Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis

Chronic Periaortitis Clinical Trial

Official title:

Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05133895
• Other study ID #: Tocilizumab for Periaortitis
• Status: Completed
• Start date: July 15, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periaortitis
• Retroperitoneal Fibrosis

Intervention

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

Locations

Country	Name	City	State
China	Yunyun Fei	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment response	the rate of partial remission and complete remission after 3-month TCZ monotherapy	three months
Secondary	the frequency of treatment related adverse events	adverse events caused by TCZ during 3-month follow-up.	three months
Secondary	the improvement of inflammatory markers	including erythrocyte sedimentation rate (ESR) and high-sensitivity C-reactive protein (hsCRP).	three months