Trial Outcomes & Findings for Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis (NCT NCT03286556)
NCT ID: NCT03286556
Last Updated: 2026-02-24
Results Overview
Actuarial survival
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
6 months
Results posted on
2026-02-24
Participant Flow
Participant milestones
| Measure |
Autoantibody Reductive Therapy
Therapeutic Plasma Exchange (TPE) consisting of 1x estimated plasma volume exchanges for 3 successive days (1-3) and then, after a one day interval to enable equilibration of autoantibodies between intra- and extra-vascular spaces, again on days 5, 6, 9, 11, 13, and 15.
Rituximab: One gm i.v. will be administered on day 6 and day 15 after completion of the TPE on those days.
Intravenous immunoglobulin (IVIG): 0.5 gm/kg/day i.v. on days 16-19
All subjects in this trial, including patients in this arm, will receive identical empiric antibiotics and steroids. The steroid dose is: Prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 6 and 15, as a premedication prior to the rituximab.
Autoantibody Reductive Therapy: TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
|
Treatment as Usual (TAU)
The same steroid regimen as described for the experimental arm, i.e., prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent), and methylprednisolone 100 mg i.v. administered on days 6 and 15, as well as empiric antibiotics.
Treatment as Usual (TAU): Antibiotics and steroids
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
18
|
|
Overall Study
COMPLETED
|
31
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Autoantibody Reductive Therapy
Therapeutic Plasma Exchange (TPE) consisting of 1x estimated plasma volume exchanges for 3 successive days (1-3) and then, after a one day interval to enable equilibration of autoantibodies between intra- and extra-vascular spaces, again on days 5, 6, 9, 11, 13, and 15.
Rituximab: One gm i.v. will be administered on day 6 and day 15 after completion of the TPE on those days.
Intravenous immunoglobulin (IVIG): 0.5 gm/kg/day i.v. on days 16-19
All subjects in this trial, including patients in this arm, will receive identical empiric antibiotics and steroids. The steroid dose is: Prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 6 and 15, as a premedication prior to the rituximab.
Autoantibody Reductive Therapy: TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
|
Treatment as Usual (TAU)
The same steroid regimen as described for the experimental arm, i.e., prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent), and methylprednisolone 100 mg i.v. administered on days 6 and 15, as well as empiric antibiotics.
Treatment as Usual (TAU): Antibiotics and steroids
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
Autoantibody Reductive Therapy
n=33 Participants
Therapeutic Plasma Exchange (TPE) consisting of 1x estimated plasma volume exchanges for 3 successive days (1-3) and then, after a one day interval to enable equilibration of autoantibodies between intra- and extra-vascular spaces, again on days 5, 6, 9, 11, 13, and 15.
Rituximab: One gm i.v. will be administered on day 6 and day 15 after completion of the TPE on those days.
Intravenous immunoglobulin (IVIG): 0.5 gm/kg/day i.v. on days 16-19
All subjects in this trial, including patients in this arm, will receive identical empiric antibiotics and steroids. The steroid dose is: Prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 6 and 15, as a premedication prior to the rituximab.
Autoantibody Reductive Therapy: TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
|
Treatment as Usual (TAU)
n=18 Participants
The same steroid regimen as described for the experimental arm, i.e., prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent), and methylprednisolone 100 mg i.v. administered on days 6 and 15, as well as empiric antibiotics.
Treatment as Usual (TAU): Antibiotics and steroids
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=58 Participants
|
18 Participants
|
51 Participants
n=1 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 7 • n=58 Participants
|
70 years
STANDARD_DEVIATION 8
|
70 years
STANDARD_DEVIATION 7 • n=1 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=58 Participants
|
2 Participants
|
15 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=58 Participants
|
16 Participants
|
36 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=58 Participants
|
0 Participants
|
1 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=58 Participants
|
18 Participants
|
49 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=58 Participants
|
0 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=58 Participants
|
1 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=58 Participants
|
0 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=58 Participants
|
17 Participants
|
49 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=58 Participants
|
18 participants
|
51 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsActuarial survival
Outcome measures
| Measure |
Autoantibody Reductive Therapy
n=33 Participants
Therapeutic Plasma Exchange (TPE) consisting of 1x estimated plasma volume exchanges for 3 successive days (1-3) and then, after a one day interval to enable equilibration of autoantibodies between intra- and extra-vascular spaces, again on days 5, 6, 9, 11, 13, and 15.
Rituximab: One gm i.v. will be administered on day 6 and day 15 after completion of the TPE on those days.
Intravenous immunoglobulin (IVIG): 0.5 gm/kg/day i.v. on days 16-19
All subjects in this trial, including patients in this arm, will receive identical empiric antibiotics and steroids. The steroid dose is: Prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 6 and 15, as a premedication prior to the rituximab.
Autoantibody Reductive Therapy: TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
|
Treatment as Usual (TAU)
n=18 Participants
The same steroid regimen as described for the experimental arm, i.e., prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent), and methylprednisolone 100 mg i.v. administered on days 6 and 15, as well as empiric antibiotics.
Treatment as Usual (TAU): Antibiotics and steroids
|
|---|---|---|
|
%Survival
|
44 percentage of participants
Standard Error 9
|
7 percentage of participants
Standard Error 6
|
SECONDARY outcome
Timeframe: before and immediately after hospital treatmentChanges in amount of supplemental oxygen, as liters/min or % fractional inspired oxygen concentration, required to maintain arterial oxygen concentration (SaO2) \>/=93%
Outcome measures
| Measure |
Autoantibody Reductive Therapy
n=33 Participants
Therapeutic Plasma Exchange (TPE) consisting of 1x estimated plasma volume exchanges for 3 successive days (1-3) and then, after a one day interval to enable equilibration of autoantibodies between intra- and extra-vascular spaces, again on days 5, 6, 9, 11, 13, and 15.
Rituximab: One gm i.v. will be administered on day 6 and day 15 after completion of the TPE on those days.
Intravenous immunoglobulin (IVIG): 0.5 gm/kg/day i.v. on days 16-19
All subjects in this trial, including patients in this arm, will receive identical empiric antibiotics and steroids. The steroid dose is: Prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 6 and 15, as a premedication prior to the rituximab.
Autoantibody Reductive Therapy: TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
|
Treatment as Usual (TAU)
n=18 Participants
The same steroid regimen as described for the experimental arm, i.e., prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent), and methylprednisolone 100 mg i.v. administered on days 6 and 15, as well as empiric antibiotics.
Treatment as Usual (TAU): Antibiotics and steroids
|
|---|---|---|
|
Percentage of Participants With a Change in Oxygen Requirements to Maintain Adequate SaO2
|
50 % participants with O2 reductions
|
22 % participants with O2 reductions
|
SECONDARY outcome
Timeframe: 6 months6 minute walk distance using standardized American Thoracic Society/European Respiratory Society (ATS/ERS) protocols.
Outcome measures
| Measure |
Autoantibody Reductive Therapy
n=33 Participants
Therapeutic Plasma Exchange (TPE) consisting of 1x estimated plasma volume exchanges for 3 successive days (1-3) and then, after a one day interval to enable equilibration of autoantibodies between intra- and extra-vascular spaces, again on days 5, 6, 9, 11, 13, and 15.
Rituximab: One gm i.v. will be administered on day 6 and day 15 after completion of the TPE on those days.
Intravenous immunoglobulin (IVIG): 0.5 gm/kg/day i.v. on days 16-19
All subjects in this trial, including patients in this arm, will receive identical empiric antibiotics and steroids. The steroid dose is: Prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 6 and 15, as a premedication prior to the rituximab.
Autoantibody Reductive Therapy: TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
|
Treatment as Usual (TAU)
n=18 Participants
The same steroid regimen as described for the experimental arm, i.e., prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent), and methylprednisolone 100 mg i.v. administered on days 6 and 15, as well as empiric antibiotics.
Treatment as Usual (TAU): Antibiotics and steroids
|
|---|---|---|
|
Walk Distance
|
245 feet
Standard Deviation 347
|
133 feet
Standard Deviation 216
|
Adverse Events
Autoantibody Reductive Therapy
Serious events: 5 serious events
Other events: 6 other events
Deaths: 18 deaths
Treatment as Usual (TAU)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Autoantibody Reductive Therapy
n=33 participants at risk
Therapeutic Plasma Exchange (TPE) consisting of 1x estimated plasma volume exchanges for 3 successive days (1-3) and then, after a one day interval to enable equilibration of autoantibodies between intra- and extra-vascular spaces, again on days 5, 6, 9, 11, 13, and 15.
Rituximab: One gm i.v. will be administered on day 6 and day 15 after completion of the TPE on those days.
Intravenous immunoglobulin (IVIG): 0.5 gm/kg/day i.v. on days 16-19
All subjects in this trial, including patients in this arm, will receive identical empiric antibiotics and steroids. The steroid dose is: Prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 6 and 15, as a premedication prior to the rituximab.
Autoantibody Reductive Therapy: TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
|
Treatment as Usual (TAU)
n=18 participants at risk
The same steroid regimen as described for the experimental arm, i.e., prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent), and methylprednisolone 100 mg i.v. administered on days 6 and 15, as well as empiric antibiotics.
Treatment as Usual (TAU): Antibiotics and steroids
|
|---|---|---|
|
Blood and lymphatic system disorders
Hematoma at plasma exchange catheter site
|
3.0%
1/33 • Number of events 1 • 180 days
|
0.00%
0/18 • 180 days
|
|
Nervous system disorders
Transient ischemic attack
|
3.0%
1/33 • Number of events 1 • 180 days
|
0.00%
0/18 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
3.0%
1/33 • Number of events 1 • 180 days
|
0.00%
0/18 • 180 days
|
|
Hepatobiliary disorders
Transaminitis
|
3.0%
1/33 • Number of events 1 • 180 days
|
0.00%
0/18 • 180 days
|
|
Nervous system disorders
Subcortical Cerebral Ischemia
|
3.0%
1/33 • Number of events 1 • 180 days
|
0.00%
0/18 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Drug Reaction
|
3.0%
1/33 • Number of events 1 • 180 days
|
0.00%
0/18 • 180 days
|
Other adverse events
| Measure |
Autoantibody Reductive Therapy
n=33 participants at risk
Therapeutic Plasma Exchange (TPE) consisting of 1x estimated plasma volume exchanges for 3 successive days (1-3) and then, after a one day interval to enable equilibration of autoantibodies between intra- and extra-vascular spaces, again on days 5, 6, 9, 11, 13, and 15.
Rituximab: One gm i.v. will be administered on day 6 and day 15 after completion of the TPE on those days.
Intravenous immunoglobulin (IVIG): 0.5 gm/kg/day i.v. on days 16-19
All subjects in this trial, including patients in this arm, will receive identical empiric antibiotics and steroids. The steroid dose is: Prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 6 and 15, as a premedication prior to the rituximab.
Autoantibody Reductive Therapy: TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
|
Treatment as Usual (TAU)
n=18 participants at risk
The same steroid regimen as described for the experimental arm, i.e., prednisone 60 mg (p.o.) on day 1, followed by 20 mg/day on days 2-5, 7-14, and 16-19 (or the i.v. methylprednisolone equivalent), and methylprednisolone 100 mg i.v. administered on days 6 and 15, as well as empiric antibiotics.
Treatment as Usual (TAU): Antibiotics and steroids
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
18.2%
6/33 • Number of events 6 • 180 days
|
11.1%
2/18 • Number of events 2 • 180 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
4/33 • Number of events 4 • 180 days
|
5.6%
1/18 • Number of events 1 • 180 days
|
|
Cardiac disorders
Hypotension
|
6.1%
2/33 • Number of events 2 • 180 days
|
5.6%
1/18 • Number of events 1 • 180 days
|
|
Nervous system disorders
Weakness
|
9.1%
3/33 • Number of events 3 • 180 days
|
0.00%
0/18 • 180 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place