Chronic PeriaortitisNCT05133895
Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis
An observational study of Chronic Periaortitis and Tocilizumab Monotherapy, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Periaortitis, Tocilizumab Monotherapy
- What is being tested?
- Tocilizumab monotherapy
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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%.
- Conditions
- Chronic Periaortitis, Tocilizumab Monotherapy
- Being tested
- Tocilizumab monotherapy
- Keywords
- chronic periaortitis, Tocilizumab, treatment response, complete remission, partial remission
- Medical subject headings
- Retroperitoneal Fibrosis, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab monotherapyDrug
intravenous infusions of TCZ (8 mg/kg) at inclusion and then every 4 weeks for at least 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tocilizumab monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment response
the rate of partial remission and complete remission after 3-month TCZ monotherapy
Measured: three months
Secondary outcomes (2)
the frequency of treatment related adverse events
adverse events caused by TCZ during 3-month follow-up.
Measured: three months
the improvement of inflammatory markers
including erythrocyte sedimentation rate (ESR) and high-sensitivity C-reactive protein (hsCRP).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start15 Jul 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriaortitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Zhang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133895
- Sponsor's protocol ID
- Tocilizumab for Periaortitis
- Status last verified
- Mar 2023
- First submitted
- 14 Nov 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis
- ClinicalTrials.gov ID
- NCT05133895
- Acronym / sponsor ID
- Tocilizumab for Periaortitis
- Conditions
- Chronic Periaortitis, Tocilizumab Monotherapy
- Keywords
- chronic periaortitis, Tocilizumab, treatment response, complete remission, partial remission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab monotherapy | – | Drug: Tocilizumab monotherapyPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocilizumab monotherapyintravenous infusions of TCZ (8 mg/kg) at inclusion and then every 4 weeks for at least 3 months | Drug | Tocilizumab monotherapy |
Primary outcome
treatment response
Time frame: three months
the rate of partial remission and complete remission after 3-month TCZ monotherapy
2 secondary outcomes
the frequency of treatment related adverse events
Time frame: three months
the improvement of inflammatory markers
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periaortitis and Tocilizumab Monotherapy, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment response (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.