Trial Outcomes & Findings for Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease. (NCT NCT04413149)
NCT ID: NCT04413149
Last Updated: 2024-05-17
Results Overview
Death from all causes Retrieved from medical records.
Recruitment status
COMPLETED
Target enrollment
80 participants
Primary outcome timeframe
From baseline until the date of death from all cause, up to 5 years
Results posted on
2024-05-17
Participant Flow
Participant milestones
| Measure |
MPA-ILD Group
Among all the patients with ANCA-positive ILD, patients who fulfilled the MPA criteria were defined as MPA-ILD group.
|
ANCA-IIP Group
Patients with isolated ANCA-positivity who did not fulfill the MPA criteria were classified as ANCA-IIP group.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
49
|
|
Overall Study
COMPLETED
|
20
|
44
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
| Measure |
MPA-ILD Group
Among all the patients with ANCA-positive ILD, patients who fulfilled the MPA criteria were defined as MPA-ILD group.
|
ANCA-IIP Group
Patients with isolated ANCA-positivity who did not fulfill the MPA criteria were classified as ANCA-IIP group.
|
|---|---|---|
|
Overall Study
Death
|
10
|
5
|
|
Overall Study
Lung transplantation
|
1
|
0
|
Baseline Characteristics
Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.
Baseline characteristics by cohort
| Measure |
MPA-ILD Group
n=31 Participants
Among all the patients with ANCA-positive ILD, patients who fulfilled the MPA criteria were defined as MPA-ILD group.
|
ANCA-IIP Group
n=49 Participants
Patients with isolated ANCA-positivity who did not fulfill the MPA criteria were classified as ANCA-IIP group.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
59 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
31 participants
n=5 Participants
|
49 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Follow-up time
|
36 months
n=5 Participants
|
41 months
n=7 Participants
|
40 months
n=5 Participants
|
|
Fever
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Cough
|
28 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Dyspnea
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Fatigue
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Arthralgia
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Crackling sound
|
19 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Rash
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Clubbing fingers
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Mechanics hand
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Gottron's sign
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Renal involvement
|
30 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Nervous system involvement
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Cardiovascular involvement
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Retinal involvement
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
White blood cell
|
9.34 ×10^9 cells/L
n=5 Participants
|
7.44 ×10^9 cells/L
n=7 Participants
|
8.54 ×10^9 cells/L
n=5 Participants
|
|
Neutrophil
|
6.79 ×10^9 cells/L
n=5 Participants
|
4.68 ×10^9 cells/L
n=7 Participants
|
5.65 ×10^9 cells/L
n=5 Participants
|
|
Lymphocyte
|
1.47 ×10^9 cells/L
n=5 Participants
|
2 ×10^9 cells/L
n=7 Participants
|
1.90 ×10^9 cells/L
n=5 Participants
|
|
Hemoglobin
|
116 g/L
n=5 Participants
|
137 g/L
n=7 Participants
|
132 g/L
n=5 Participants
|
|
Platelet
|
251 ×10^9 cells/L
n=5 Participants
|
234 ×10^9 cells/L
n=7 Participants
|
246 ×10^9 cells/L
n=5 Participants
|
|
Erythrocyte sedimentation rate
|
86 mm/h
n=5 Participants
|
28 mm/h
n=7 Participants
|
53 mm/h
n=5 Participants
|
|
C reactive protein
|
35.77 mg/dL
n=5 Participants
|
13.87 mg/dL
n=7 Participants
|
15.92 mg/dL
n=5 Participants
|
|
PaO2
|
71.5 mmHg
n=5 Participants
|
77.4 mmHg
n=7 Participants
|
75.9 mmHg
n=5 Participants
|
|
Creatinine
|
73 μmol/L
n=5 Participants
|
67 μmol/L
n=7 Participants
|
68 μmol/L
n=5 Participants
|
|
MPO-ANCA positive
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
PR3-ANCA positive
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Rheumatoid factor
|
113.1 IU/mL
n=5 Participants
|
26.7 IU/mL
n=7 Participants
|
55.9 IU/mL
n=5 Participants
|
|
ANA positive
|
15 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Anti-CCP positive
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
SSA positive
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
SSB positive
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Jo-1 positive
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Scl-70 positive
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
FEV1
|
79.36 percent predicted
STANDARD_DEVIATION 17.92 • n=5 Participants
|
84.03 percent predicted
STANDARD_DEVIATION 16.93 • n=7 Participants
|
82.35 percent predicted
STANDARD_DEVIATION 17.32 • n=5 Participants
|
|
FVC
|
78.30 percent predicted
STANDARD_DEVIATION 16.89 • n=5 Participants
|
83.84 percent predicted
STANDARD_DEVIATION 19.10 • n=7 Participants
|
81.85 percent predicted
STANDARD_DEVIATION 18.42 • n=5 Participants
|
|
TLC
|
74.16 percent predicted
STANDARD_DEVIATION 12.73 • n=5 Participants
|
79.53 percent predicted
STANDARD_DEVIATION 13.55 • n=7 Participants
|
77.59 percent predicted
STANDARD_DEVIATION 13.43 • n=5 Participants
|
|
DLCO
|
56.56 percent predicted
STANDARD_DEVIATION 17.52 • n=5 Participants
|
62.12 percent predicted
STANDARD_DEVIATION 14.09 • n=7 Participants
|
60.12 percent predicted
STANDARD_DEVIATION 15.53 • n=5 Participants
|
|
Ground-glass opacity
|
25 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Consolidation
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Traction bronchiectasis
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Honeycombing
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Pulmonary artery dilation
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Reticular pattern
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Curved linear opacity
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Pleural thickening
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Interlobular septal thickening
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Micronodular pattern
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Subpleural bulla
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Enlarged mediastinal lymph node
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Usual interstitial pneumonia
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Nonspecific interstitial pneumonia
|
18 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Unclassifiable HRCT pattern
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline until the date of death from all cause, up to 5 yearsDeath from all causes Retrieved from medical records.
Outcome measures
| Measure |
MPA-ILD Group
n=31 Participants
Among all the patients with ANCA-positive ILD, patients who fulfilled the MPA criteria were defined as MPA-ILD group.
|
ANCA-IIP Group
n=49 Participants
Patients with isolated ANCA-positivity who did not fulfill the MPA criteria were classified as ANCA-IIP group.
|
|---|---|---|
|
Death From All Causes
|
10 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From baseline until the date of transplantation, up to 5 yearsNumber of patients who underwent lung transplantation Retrieved from medical records.
Outcome measures
| Measure |
MPA-ILD Group
n=31 Participants
Among all the patients with ANCA-positive ILD, patients who fulfilled the MPA criteria were defined as MPA-ILD group.
|
ANCA-IIP Group
n=49 Participants
Patients with isolated ANCA-positivity who did not fulfill the MPA criteria were classified as ANCA-IIP group.
|
|---|---|---|
|
Number of Patients Who Underwent Lung Transplantation
|
1 Participants
|
0 Participants
|
Adverse Events
MPA-ILD Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
ANCA-IIP Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Shi Juhong
Peking Union Medical College Hospital
Phone: +86-13701178492
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place