Clinical trial NCT02126098: Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis
Official title: Cohort Study of Chinese Patients With Pulmonary Vasculitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who newly diagnosed ANCA-vasculitis

Brief 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.

Detailed description: Presentation of patient with suspected vasculitis

1. Established diagnosis Clinical findings Laboratory workup Tissue biopsy Angiogram where appropriate
2. Evaluating respiratory system Chest HRCT Pulmonary function test Bronchoscopy exam(BALF, TBB) Lung biopsy(needle biopsy, VAST)
3. screening underlying damage to other system Paranasal sinus, vision \& audition Nervous system Kidney Gastrointestinal tract Heart \& vessel Skin Hematology Muscle, bone \& joint
4. Treatment
5. Prognosis

Evaluation

1. Study visits occurred at baseline; at weeks 4; and at 2, 4, 6,12,18,24,30 months.
2. Disease activity was measured on the basis of the BVAS/WG and the physician's global assessment.
3. 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).
4. 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.
5. Serial serum samples were tested for proteinase 3-ANCA and myeloperoxidase-ANCA by means of a direct enzyme-linked immunosorbent assay (ELISA).

Eligibility criteria: Inclusion Criteria:

* Males and Females
* Aged from 18-75 years with informed consent
* Patients with ANCA-vasculitis

  1. Wegener's granulomatosis, microscopic polyangiitis or CSS
  2. positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA
  3. 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)

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential
* Secondary vasculitis, cancer,infective disease or drug induced vasculitis

Primary outcomes:
measure: Completely Remission
timeFrame: 6 months
Secondary outcomes:
measure: Disease flare
timeFrame: during the period of observation(30months)
Other outcomes:
measure: Adverse events
timeFrame: during the period of observation (30months)
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Juhong Shi, M.D
role: STUDY_CHAIR
References: