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=99 Participants
|
59 years
n=107 Participants
|
60 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
31 participants
n=99 Participants
|
49 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Follow-up time
|
36 months
n=99 Participants
|
41 months
n=107 Participants
|
40 months
n=206 Participants
|
|
Fever
|
16 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Cough
|
28 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Dyspnea
|
20 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Fatigue
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Arthralgia
|
8 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Crackling sound
|
19 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Rash
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Clubbing fingers
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Mechanics hand
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Gottron's sign
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Renal involvement
|
30 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Nervous system involvement
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Cardiovascular involvement
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Retinal involvement
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
White blood cell
|
9.34 ×10^9 cells/L
n=99 Participants
|
7.44 ×10^9 cells/L
n=107 Participants
|
8.54 ×10^9 cells/L
n=206 Participants
|
|
Neutrophil
|
6.79 ×10^9 cells/L
n=99 Participants
|
4.68 ×10^9 cells/L
n=107 Participants
|
5.65 ×10^9 cells/L
n=206 Participants
|
|
Lymphocyte
|
1.47 ×10^9 cells/L
n=99 Participants
|
2 ×10^9 cells/L
n=107 Participants
|
1.90 ×10^9 cells/L
n=206 Participants
|
|
Hemoglobin
|
116 g/L
n=99 Participants
|
137 g/L
n=107 Participants
|
132 g/L
n=206 Participants
|
|
Platelet
|
251 ×10^9 cells/L
n=99 Participants
|
234 ×10^9 cells/L
n=107 Participants
|
246 ×10^9 cells/L
n=206 Participants
|
|
Erythrocyte sedimentation rate
|
86 mm/h
n=99 Participants
|
28 mm/h
n=107 Participants
|
53 mm/h
n=206 Participants
|
|
C reactive protein
|
35.77 mg/dL
n=99 Participants
|
13.87 mg/dL
n=107 Participants
|
15.92 mg/dL
n=206 Participants
|
|
PaO2
|
71.5 mmHg
n=99 Participants
|
77.4 mmHg
n=107 Participants
|
75.9 mmHg
n=206 Participants
|
|
Creatinine
|
73 μmol/L
n=99 Participants
|
67 μmol/L
n=107 Participants
|
68 μmol/L
n=206 Participants
|
|
MPO-ANCA positive
|
26 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
PR3-ANCA positive
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Rheumatoid factor
|
113.1 IU/mL
n=99 Participants
|
26.7 IU/mL
n=107 Participants
|
55.9 IU/mL
n=206 Participants
|
|
ANA positive
|
15 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Anti-CCP positive
|
0 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
SSA positive
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
SSB positive
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Jo-1 positive
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Scl-70 positive
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
FEV1
|
79.36 percent predicted
STANDARD_DEVIATION 17.92 • n=99 Participants
|
84.03 percent predicted
STANDARD_DEVIATION 16.93 • n=107 Participants
|
82.35 percent predicted
STANDARD_DEVIATION 17.32 • n=206 Participants
|
|
FVC
|
78.30 percent predicted
STANDARD_DEVIATION 16.89 • n=99 Participants
|
83.84 percent predicted
STANDARD_DEVIATION 19.10 • n=107 Participants
|
81.85 percent predicted
STANDARD_DEVIATION 18.42 • n=206 Participants
|
|
TLC
|
74.16 percent predicted
STANDARD_DEVIATION 12.73 • n=99 Participants
|
79.53 percent predicted
STANDARD_DEVIATION 13.55 • n=107 Participants
|
77.59 percent predicted
STANDARD_DEVIATION 13.43 • n=206 Participants
|
|
DLCO
|
56.56 percent predicted
STANDARD_DEVIATION 17.52 • n=99 Participants
|
62.12 percent predicted
STANDARD_DEVIATION 14.09 • n=107 Participants
|
60.12 percent predicted
STANDARD_DEVIATION 15.53 • n=206 Participants
|
|
Ground-glass opacity
|
25 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Consolidation
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Traction bronchiectasis
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Honeycombing
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Pulmonary artery dilation
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Reticular pattern
|
20 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Curved linear opacity
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Pleural thickening
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Interlobular septal thickening
|
16 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Micronodular pattern
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Subpleural bulla
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Enlarged mediastinal lymph node
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Usual interstitial pneumonia
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Nonspecific interstitial pneumonia
|
18 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Unclassifiable HRCT pattern
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 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