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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02126098
Other study ID # PUMCH-PULMONARY DISEASES
Secondary ID 2011BA11B17
Status Not yet recruiting
Phase N/A
First received April 27, 2014
Last updated April 27, 2014
Start date May 2014
Est. completion date December 2017

Study information

Verified date April 2014
Source Peking Union Medical College Hospital
Contact Juhong Shi, M.D
Phone +861069155028
Email juhong_shi@hotmail.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational [Patient Registry]

Clinical 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events deaths (from all causes)
malignant conditions
grade 2 or higher leukopenia or thrombocytopenia
grade 3 or higher infections
drug induced cystitis
venous thromboembolic events
stroke
hospitalizations
during the period of observation (30months) No
Primary Completely Remission BVAS/WG of 0 and successful completion of the prednisone taper at 6 months. 6 months No
Secondary 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.
during the period of observation(30months) No
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