Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis

Microscopic Polyangiitis Clinical Trial

Official title:

Cohort Study of Chinese Patients With Pulmonary Vasculitis

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

• ANCA-associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• EosinphilicGranulomatosis With Polyangiitis
• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis
• Systemic Vasculitis
• Vasculitis
• Wegener Granulomatosis

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