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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT02126098
First received: April 27, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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.


Condition
ANCA-associated Vasculitis
Granulomatosis With Polyangiitis
Microscopic Polyangiitis
EosinphilicGranulomatosis With Polyangiitis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Months
Official Title: Cohort Study of Chinese Patients With Pulmonary Vasculitis

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Completely Remission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    BVAS/WG of 0 and successful completion of the prednisone taper at 6 months.


Secondary Outcome Measures:
  • Disease flare [ Time Frame: during the period of observation(30months) ] [ Designated as safety issue: No ]

    Disease flare

    1. an increase in the BVAS/WG of 1 point or more.
    2. 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.


Other Outcome Measures:
  • Adverse events [ Time Frame: during the period of observation (30months) ] [ Designated as safety issue: No ]
    1. deaths (from all causes)
    2. malignant conditions
    3. grade 2 or higher leukopenia or thrombocytopenia
    4. grade 3 or higher infections
    5. drug induced cystitis
    6. venous thromboembolic events
    7. stroke
    8. hospitalizations


Biospecimen Retention:   Samples With DNA

serum lymphocytes urine


Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who newly diagnosed ANCA-vasculitis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02126098

Contacts
Contact: Juhong Shi, M.D +861069155028 juhong_shi@hotmail.com
Contact: Ling Qin, M.D +861069155028 qinlingpumch@126.com

Locations
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Juhong Shi, M.D Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02126098     History of Changes
Other Study ID Numbers: PUMCH-PULMONARY DISEASES, 2011BA11B17
Study First Received: April 27, 2014
Last Updated: April 27, 2014
Health Authority: China: Ethics Committee

Keywords provided by Peking Union Medical College Hospital:
ANCA-associated vasculitis
Granulomatosis with polyangiitis
Microscopic polyangiitis
Wegner's granulomatosis
Eosinphilic granulomatosis with polyangiitis

Additional relevant MeSH terms:
Wegener Granulomatosis
Vasculitis
Systemic Vasculitis
Microscopic Polyangiitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014