ANCA-associated VasculitisNCT02126098
Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis
An observational study of ANCA-associated Vasculitis and Granulomatosis With Polyangiitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe the clinical manifestation, Lab findings including chest CT scans, pathological findings and outcomes in chinese patients with pulminary vasculitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ANCA-associated Vasculitis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2017
- How long will I take part?
- 30 Months
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who newly diagnosed ANCA-vasculitis
Who may be able to join
- Males and Females
- Aged from 18-75 years with informed consent
- Patients with ANCA-vasculitis
- Wegener's granulomatosis, microscopic polyangiitis or CSS
- positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA
- manifestations of activity disease, and Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 3 or more (scores range from 0 to 63, with higher scores indicating more active disease)
Who cannot join
- Females planning to bear a child recently or with childbearing potential
- Secondary vasculitis, cancer,infective disease or drug induced vasculitis
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Cohort Study of Chinese Patients With Pulmonary Vasculitis
The purpose of this study is to observe the clinical manifestation, Lab findings including chest CT scans, pathological findings and outcomes in chinese patients with pulminary vasculitis.
Read the detailed description
Presentation of patient with suspected vasculitis
- Established diagnosis Clinical findings Laboratory workup Tissue biopsy Angiogram where appropriate
- Evaluating respiratory system Chest HRCT Pulmonary function test Bronchoscopy exam(BALF, TBB) Lung biopsy(needle biopsy, VAST)
- screening underlying damage to other system Paranasal sinus, vision \& audition Nervous system Kidney Gastrointestinal tract Heart \& vessel Skin Hematology Muscle, bone \& joint
- Treatment
- Prognosis
Evaluation
- Study visits occurred at baseline; at weeks 4; and at 2, 4, 6,12,18,24,30 months.
- Disease activity was measured on the basis of the BVAS/WG and the physician's global assessment.
- Damage related to disease or treatment was scored according to the Vasculitis Damage Index (scores for this index range from 0 to 64, with higher scores in- dicating more severe damage).
- Health related quality of life was scored with the use of the Med- ical Outcomes Study 36-Item Short-Form Health Survey (SF-36).Scores on this scale range from 0 to 100, with higher scores indicating better health.
- Serial serum samples were tested for proteinase 3-ANCA and myeloperoxidase-ANCA by means of a direct enzyme-linked immunosorbent assay (ELISA).
- Conditions
- ANCA-associated Vasculitis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis, EosinphilicGranulomatosis With Polyangiitis
- Keywords
- ANCA-associated vasculitis, Granulomatosis with polyangiitis, Microscopic polyangiitis, Wegner's granulomatosis, Eosinphilic granulomatosis with polyangiitis
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults who diagosed ANCA-vasculitis | Patients with Wegener's granulomatosis or microscopic polyangiitis were eligible to participate in the study if they had 1. Positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA 2. manifestations of severe disease,11 and a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 3 or more (scores range from 0 to 63, with higher scores indicating more active disease) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completely Remission
BVAS/WG of 0 and successful completion of the prednisone taper at 6 months.
Measured: 6 months
Secondary outcomes (1)
Disease flare
Disease flare
- an increase in the BVAS/WG of 1 point or more.
- Patients were classified as having early treatment failure if at 1 month their BVAS/WG had not decreased by at least 1 point or a new manifestation of disease had emerged.
Measured: during the period of observation(30months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA-associated VasculitisStudies 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
- 100 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juhong Shi, M.D, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126098
- Sponsor's protocol ID
- PUMCH-PULMONARY DISEASES
- Other IDs
- 2011BA11B17
- Status last verified
- Apr 2014
- First submitted
- 27 Apr 2014
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Chinese Patients With Pulmonary Vasculitis
- ClinicalTrials.gov ID
- NCT02126098
- Acronym / sponsor ID
- PUMCH-PULMONARY DISEASES
- Conditions
- ANCA-associated Vasculitis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis, EosinphilicGranulomatosis With Polyangiitis
- Keywords
- ANCA-associated vasculitis, Granulomatosis with polyangiitis, Microscopic polyangiitis, Wegner's granulomatosis, Eosinphilic granulomatosis with polyangiitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Apr 2014 (estimated)
- 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.
The purpose of this study is to observe the clinical manifestation, Lab findings including chest CT scans, pathological findings and outcomes in chinese patients with pulminary vasculitis.
Detailed description
Presentation of patient with suspected vasculitis
- Established diagnosis Clinical findings Laboratory workup Tissue biopsy Angiogram where appropriate
- Evaluating respiratory system Chest HRCT Pulmonary function test Bronchoscopy exam(BALF, TBB) Lung biopsy(needle biopsy, VAST)
- screening underlying damage to other system Paranasal sinus, vision \& audition Nervous system Kidney Gastrointestinal tract Heart \& vessel Skin Hematology Muscle, bone \& joint
- Treatment
- Prognosis
Evaluation
- Study visits occurred at baseline; at weeks 4; and at 2, 4, 6,12,18,24,30 months.
- Disease activity was measured on the basis of the BVAS/WG and the physician's global assessment.
- Damage related to disease or treatment was scored according to the Vasculitis Damage Index (scores for this index range from 0 to 64, with higher scores in- dicating more severe damage).
- Health related quality of life was scored with the use of the Med- ical Outcomes Study 36-Item Short-Form Health Survey (SF-36).Scores on this scale range from 0 to 100, with higher scores indicating better health.
- Serial serum samples were tested for proteinase 3-ANCA and myeloperoxidase-ANCA by means of a direct enzyme-linked immunosorbent assay (ELISA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults who diagosed ANCA-vasculitis | – | –Patients with Wegener's granulomatosis or microscopic polyangiitis were eligible to participate in the study if they had 1. Positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA 2. manifestations of severe disease,11 and a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 3 or more (scores range from 0 to 63, with higher scores indicating more active disease) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who newly diagnosed ANCA-vasculitis
Key inclusion criteria (6 listed)
- Males and Females
- Aged from 18-75 years with informed consent
- Patients with ANCA-vasculitis
Key exclusion criteria (2 listed)
- Females planning to bear a child recently or with childbearing potential
- Secondary vasculitis, cancer,infective disease or drug induced vasculitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completely Remission
Time frame: 6 months
BVAS/WG of 0 and successful completion of the prednisone taper at 6 months.
1 secondary outcome
Disease flare
Time frame: during the period of observation(30months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
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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.
Juhong Shi, M.D study chair
Peking Union Medical College Hospital
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 ANCA-associated Vasculitis and Granulomatosis With Polyangiitis, 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Apr 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juhong Shi, M.D (+861069155028, juhong_shi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completely Remission (time frame: 6 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 29 Apr 2014.