CompletedNot Applicable

Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis

China12 participantsStarted 2020-07-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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.

What they're measuring

treatment response

Timeframe: three months

Trial details

NCT IDNCT05133895

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Chronic Periaortitis trials