Trial · NCT03215927

Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease

NCT03215927, Phase 2, Completed, Rohit Aggarwal, MD; results first posted 2025-01-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease. Trials, record NCT03215927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03215927

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease
NCT number: NCT03215927
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Rohit Aggarwal, MD
Conditions: Myositis, Interstitial Lung Disease
Interventions: Abatacept, Placebo
First posted: 2017-07-12
Last updated: 2025-01-07
Results first posted: 2025-01-07

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	% Predicted Forced Vital Capacity (FVC) Absolute Change	24 Weeks	The primary outcome criteria for efficacy will be the absolute change of % predicted FVC from the baseline visit to week 24 between the 2 treatment arms (SOC/placebo vs. SOC/Abatacept).
Secondary	Time to Progression Free Survival	48 weeks	The first occurrence of any of the following: death or lung transplantation or decline in % predicted FVC ≥ 10% or decline in % predicted FVC ≥ 5% with a decline in % predicted DLCO ≥ 15%
Secondary	Comparison of Change in Patient Reported Dyspnea Scores (University of California San Diego Shortness of Breath Questionnaire)	24 weeks	Measured by University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) (range 0-120, higher score is worsening dyspnea).
Secondary	Time to Improvement in % Predicted FVC ≥10%	48 weeks	Comparison of percent predicted FVC results from pulmonary function tests from baseline to week 48. Improvement is defined as a % predicted FVC change ≥10%

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	% Predicted Forced Vital Capacity (FVC) Absolute Change	24 Weeks	% predicted FVC	LEAST_SQUARES_MEAN
SECONDARY	Time to Progression Free Survival	48 weeks	Weeks	MEDIAN
SECONDARY	Comparison of Change in Patient Reported Dyspnea Scores (University of California San Diego Shortness of Breath Questionnaire)	24 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Time to Improvement in % Predicted FVC ≥10%	48 weeks	weeks	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
% Predicted Forced Vital Capacity (FVC) Absolute Change	Placebo	-1.70	95% Confidence Interval -5.90 to 2.50	% predicted FVC
% Predicted Forced Vital Capacity (FVC) Absolute Change	Abatacept	-2.05	95% Confidence Interval -6.97 to 2.87	% predicted FVC
Time to Progression Free Survival	Placebo	27.71	Inter-Quartile Range 12.71 to 46.86	Weeks
Time to Progression Free Survival	Abatacept	16.86	Inter-Quartile Range 15.36 to 34.93	Weeks
Comparison of Change in Patient Reported Dyspnea Scores (University of California San Diego Shortness of Breath Questionnaire)	Placebo	-4.59	95% Confidence Interval -15.54 to 6.36	score on a scale
Comparison of Change in Patient Reported Dyspnea Scores (University of California San Diego Shortness of Breath Questionnaire)	Abatacept	3.20	95% Confidence Interval -8.86 to 15.26	score on a scale
Time to Improvement in % Predicted FVC ≥10%	Placebo	17.86	Inter-Quartile Range 9.86 to 25.86	weeks
Time to Improvement in % Predicted FVC ≥10%	Abatacept	11.86	Inter-Quartile Range 11.86 to 11.86	weeks

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomized, Placebo-controlled	STARTED	Placebo	11
Randomized, Placebo-controlled	STARTED	Abatacept	9
Randomized, Placebo-controlled	COMPLETED	Placebo	11
Randomized, Placebo-controlled	COMPLETED	Abatacept	8
Randomized, Placebo-controlled	NOT COMPLETED	Placebo	0
Randomized, Placebo-controlled	NOT COMPLETED	Abatacept	1
Open Label Extension	STARTED	Placebo	11
Open Label Extension	STARTED	Abatacept	8
Open Label Extension	COMPLETED	Placebo	9
Open Label Extension	COMPLETED	Abatacept	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events84

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Excessive bruising	Blood and lymphatic system disorders	Placebo	2	11	2
other	Excessive bruising	Blood and lymphatic system disorders	Abatacept	1	20	1
other	Sinus Tachycardia	Cardiac disorders	Placebo	2	11	2
other	Sinus Tachycardia	Cardiac disorders	Abatacept	0	20	0
other	Eye Infection	Infections and infestations	Placebo	0	11	0
other	Eye Infection	Infections and infestations	Abatacept	1	9	1
other	Abdominal Pain	Gastrointestinal disorders	Placebo	0	11	0
other	Abdominal Pain	Gastrointestinal disorders	Abatacept	1	20	1
other	Nausea	Gastrointestinal disorders	Placebo	2	11	2
other	Nausea	Gastrointestinal disorders	Abatacept	0	20	0

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	11
Total, all-cause mortality	Abatacept	1	20
Total, other adverse events	Placebo	5	11
Total, other adverse events	Abatacept	6	20
Total, serious adverse events	Placebo	0	11
Total, serious adverse events	Abatacept	3	20

Source ClinicalTrials.gov

Papers24

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
10433938	BACKGROUND	PubMed
10444360	BACKGROUND	PubMed
10586079	BACKGROUND	PubMed
10604996	BACKGROUND	PubMed
12197897	BACKGROUND	PubMed
16052580	BACKGROUND	PubMed
16173253	BACKGROUND	PubMed
16227154	BACKGROUND	PubMed
18772191	BACKGROUND	PubMed
19811859	BACKGROUND	PubMed

1 to 10 of 24

See all 24 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Abatacept vs Placebo: deaths from any cause	Trial comparisons
Abatacept vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03215927

GET https://conductscience.org/api/trials/v1/NCT03215927/events?page=2

API reference For AI assistants