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

NCT02808871 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2022-08-16

Study results available
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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.

Conditions

  • Rheumatoid Arthritis Interstitial Lung Disease

Interventions

DRUG

Pirfenidone

Pirfenidone three times daily (2403 mg) for 52 weeks

DRUG

Placebo

Placebo three times daily for 52 weeks

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Ivan O. Rosas, M.D. · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-07
Primary Completion
2021-04-07
Completion
2021-04-07
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808871 on ClinicalTrials.gov