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

NCT02126098 | Unknown DMC

• 2 other identifiers: PUMCH-PULMONARY DISEASES2011BA11B17
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Completely Remission

  BVAS/WG of 0 and successful completion of the prednisone taper at 6 months.

  6 months

Secondary Outcomes (1)

• Disease flare

  during the period of observation(30months)

Other Outcomes (1)

• Adverse events

  during the period of observation (30months)

Study Arms (1)

Adults who diagosed ANCA-vasculitis

Patients with Wegener's granulomatosis or microscopic polyangiitis were eligible to participate in the study if they had 1. Positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA 2. manifestations of severe disease,11 and a 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)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who newly diagnosed ANCA-vasculitis

You may qualify if:

• Males and Females
• Aged from 18-75 years with informed consent
• Patients with ANCA-vasculitis
• Wegener's granulomatosis, microscopic polyangiitis or CSS
• positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum lymphocytes urine

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Juhong Shi, M.D

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Juhong Shi, M.D

CONTACT

+861069155028; juhong_shi@hotmail.com

Ling Qin, M.D

CONTACT

+861069155028; qinlingpumch@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2014
• First Posted: April 29, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

CN (1)