Trial · NCT02808871

Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)

NCT02808871, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2022-08-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1). Trials, record NCT02808871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02808871

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Trial

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

Title: Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
NCT number: NCT02808871
Status: Completed
Phases: Phase 2
Enrollment: 123 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Rheumatoid Arthritis Interstitial Lung Disease
Interventions: Pirfenidone, Placebo
First posted: 2016-06-22
Last updated: 2022-08-16
Results first posted: 2022-08-16

Source ClinicalTrials.gov

Registered outcomes29

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

List	Outcome	Time frame	Description
Primary	Number of Participants Who Developed Any Element of the Composite Endpoint	52 weeks	Number of participants who developed any element of the composite endpoint of decline in percent predicted FVC of 10% or greater or death.
Secondary	Number of Participants With FVC Decline From Baseline of 10% or Greater	52 weeks	Number of participants with decline from baseline in percent predicted FVC of 10% or greater during the study period.
Secondary	Number of Participants With Progressive Disease	52 weeks	Number of participants with progressive disease as defined by OMERACT: FVC% relative decline of \>=10% or FVC% change in \>=5\< 10% and \>=15% diffusing capacity (DLCO)
Secondary	Change in Absolute Value FVC Over the 52 Week Study Period	52 weeks	Change from baseline to end of study in absolute value of FVC over the 52 week study period
Secondary	Change in % Predicted FVC From Baseline to End of Study Over the 52 Week Study Period	52 weeks	Change from baseline to end of study of percent predicted FVC over the 52 week study period
Secondary	Time to Composite of Decline in FVC or Death	52 weeks	Time to decline of 10% or greater in percent predicted FVC or death while on study
Secondary	Change in PRO of Dyspnea	52 weeks	Change from Baseline to end of study in dyspnea, as measured by the Dyspnea 12 questionnaire - Total scores range from 0 to 36, with higher scores corresponding to greater severity.
Secondary	All-cause Mortality	52 weeks	Number of participants experiencing mortality due to all causes
Secondary	All Cause Hospitalization	52 weeks	Number of participants requiring hospitalization for any cause
Secondary	Hospitalization for Respiratory Cause	52 weeks	Number of participants requiring hospitalization for respiratory cause

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants Who Developed Any Element of the Composite Endpoint	52 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With FVC Decline From Baseline of 10% or Greater	52 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Progressive Disease	52 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Absolute Value FVC Over the 52 Week Study Period	52 weeks	ml	MEAN
SECONDARY	Change in % Predicted FVC From Baseline to End of Study Over the 52 Week Study Period	52 weeks	% predicted	MEAN
SECONDARY	Time to Composite of Decline in FVC or Death	52 weeks	days	MEAN
SECONDARY	Change in PRO of Dyspnea	52 weeks	score	MEAN
SECONDARY	All-cause Mortality	52 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	All Cause Hospitalization	52 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Hospitalization for Respiratory Cause	52 weeks	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group36

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

Outcome	Group	Value	Spread	Units
Number of Participants Who Developed Any Element of the Composite Endpoint	Pirfenidone	7		Participants
Number of Participants Who Developed Any Element of the Composite Endpoint	Placebo	9		Participants
Number of Participants With FVC Decline From Baseline of 10% or Greater	Pirfenidone	5		Participants
Number of Participants With FVC Decline From Baseline of 10% or Greater	Placebo	7		Participants
Number of Participants With Progressive Disease	Pirfenidone	16		Participants
Number of Participants With Progressive Disease	Placebo	19		Participants
Change in Absolute Value FVC Over the 52 Week Study Period	Pirfenidone	-66	Standard Deviation 20	ml
Change in Absolute Value FVC Over the 52 Week Study Period	Placebo	-146	Standard Deviation 20	ml
Change in % Predicted FVC From Baseline to End of Study Over the 52 Week Study Period	Pirfenidone	-1.02	Standard Deviation 0.51	% predicted
Change in % Predicted FVC From Baseline to End of Study Over the 52 Week Study Period	Placebo	-3.21	Standard Deviation 0.52	% predicted

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pirfenidone	63
Overall Study	STARTED	Placebo	60
Overall Study	COMPLETED	Pirfenidone	52
Overall Study	COMPLETED	Placebo	51
Overall Study	NOT COMPLETED	Pirfenidone	11
Overall Study	NOT COMPLETED	Placebo	9

Source ClinicalTrials.gov

Adverse events56

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
other	Blood and Lymphatic System	Blood and lymphatic system disorders	Pirfenidone	7	62
other	Blood and Lymphatic System	Blood and lymphatic system disorders	Placebo	6	60
other	Cardiac	Cardiac disorders	Pirfenidone	12	62
other	Cardiac	Cardiac disorders	Placebo	9	60
other	Ear and Labyrinth	Ear and labyrinth disorders	Pirfenidone	5	62
other	Ear and Labyrinth	Ear and labyrinth disorders	Placebo	2	60
other	Endocrine	Endocrine disorders	Pirfenidone	1	62
other	Endocrine	Endocrine disorders	Placebo	1	60
other	Eye	Eye disorders	Pirfenidone	8	62
other	Eye	Eye disorders	Placebo	4	60

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pirfenidone	2	63
Total, all-cause mortality	Placebo	3	60
Total, other adverse events	Pirfenidone	62	62
Total, other adverse events	Placebo	56	60
Total, serious adverse events	Pirfenidone	10	62
Total, serious adverse events	Placebo	11	60

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31515704	DERIVED	PubMed
36075242	DERIVED	PubMed

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 comparisons16

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

Comparison	Source
Pirfenidone vs Placebo: Hospitalization for Respiratory Cause	Trial comparisons
Pirfenidone vs Placebo: Treatment-emergent/Treatment-related SAEs	Trial comparisons
Pirfenidone vs Placebo: Number of Participants Who Developed Any Element of the Composite Endpoint	Trial comparisons
Pirfenidone vs Placebo: All-cause Mortality	Trial comparisons
Pirfenidone vs Placebo: Treatment-emergent Death or Transplant	Trial comparisons
Pirfenidone vs Placebo: Treatment-emergent/Treatment-related AEs	Trial comparisons
Pirfenidone vs Placebo: Number of Participants With Progressive Disease	Trial comparisons
Pirfenidone vs Placebo: AEs Leading to Early Discontinuation of Study Treatment	Trial comparisons
Pirfenidone vs Placebo: Treatment-emergent Serious Adverse Events (SAEs)	Trial comparisons
Pirfenidone vs Placebo: Treatment-emergent Adverse Events (AEs)	Trial comparisons

1 to 10 of 16

See all 16 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/NCT02808871

GET https://conductscience.org/api/trials/v1/NCT02808871/registered?page=2

API reference For AI assistants