CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Pirfenidone +1 moredrug
Likely dose
Pirfenidone 2403 mg orally three times daily for 52 weeksAI-extracted
Key inclusion· 10
  • ✓Age 18–85 years at screening
  • ✓Probable or definite RA diagnosis per 2010 ACR/EULAR criteria without evidence of alternative diagnosis contributing to ILD
  • ✓Diagnosis of ILD supported by HRCT and/or surgical lung biopsy prior to screening
  • ✓Fibrotic abnormality affecting >10% of lung parenchyma on screening HRCT, confirmed by adjudicated HRCT prior to baseline
Key exclusion· 24
  • ✕Cigarette smoking or vaping within 3 months of screening, or unwilling to avoid tobacco throughout the study
  • ✕History of significant environmental exposure causing pulmonary fibrosis (drugs, asbestos, beryllium, radiation, domestic birds)
  • ✕Concurrent other ILD related to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, or BOOP
  • ✕HIV or viral hepatitis (except Hep A antibody positive without elevated liver enzymes)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT02808871Phase 2Completed
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Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients With Rheumatoid Arthritis Interstitial Lung Disease (TRAIL1)

Brigham and Women's Hospital·interventional·Posted Jun 22, 2016·Updated Aug 16, 2022

In Brief

A Phase 2 clinical trial evaluating Pirfenidone and Placebo for Rheumatoid Arthritis Interstitial Lung Disease. Completed, enrolled 123 participants across 33 sites in 4 countries.

Detailed Summary

The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403 mg/day for the treatment of RA-associated interstitial lung disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis Interstitial Lung Disease
CountriesAustralia, Canada, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 22, 2016
Enrollment StartApr 7, 2017
Primary CompletionApr 7, 2021
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 10.0 years ago

Interventions

Pirfenidonedrug

Pirfenidone three times daily (2403 mg) for 52 weeks

Placebodrug

Placebo three times daily for 52 weeks