Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis
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|ClinicalTrials.gov Identifier: NCT02126098|
Recruitment Status : Unknown
Verified April 2014 by Peking Union Medical College Hospital.
Recruitment status was: Not yet recruiting
First Posted : April 29, 2014
Last Update Posted : April 29, 2014
|Condition or disease|
|ANCA-associated Vasculitis Granulomatosis With Polyangiitis Microscopic Polyangiitis EosinphilicGranulomatosis With Polyangiitis|
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).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||30 Months|
|Official Title:||Cohort Study of Chinese Patients With Pulmonary Vasculitis|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
Adults who diagosed ANCA-vasculitis
Patients with Wegener's granulomatosis or microscopic polyangiitis were eligible to participate in the study if they had
- Completely Remission [ Time Frame: 6 months ]BVAS/WG of 0 and successful completion of the prednisone taper at 6 months.
- Disease flare [ Time Frame: during the period of observation(30months) ]
- 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) ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|