Observation Study of Clinical Manifestation and Outcome in 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.
Granulomatosis With Polyangiitis
EosinphilicGranulomatosis With Polyangiitis
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||30 Months|
|Official Title:||Cohort Study of Chinese Patients With Pulmonary Vasculitis|
- Completely Remission [ Time Frame: 6 months ] [ Designated as safety issue: No ]BVAS/WG of 0 and successful completion of the prednisone taper at 6 months.
- Disease flare [ Time Frame: during the period of observation(30months) ] [ Designated as safety issue: No ]
- 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.
- Adverse events [ Time Frame: during the period of observation (30months) ] [ Designated as safety issue: No ]
- deaths (from all causes)
- malignant conditions
- grade 2 or higher leukopenia or thrombocytopenia
- grade 3 or higher infections
- drug induced cystitis
- venous thromboembolic events
Biospecimen Retention: Samples With DNA
serum lymphocytes urine
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Adults who diagosed ANCA-vasculitis
Patients with Wegener's granulomatosis or microscopic polyangiitis were eligible to participate in the study if they had
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
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02126098
|Contact: Juhong Shi, M.Dfirstname.lastname@example.org|
|Contact: Ling Qin, M.Demail@example.com|
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100730|
|Study Chair:||Juhong Shi, M.D||Peking Union Medical College Hospital|