Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
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|ClinicalTrials.gov Identifier: NCT02808871|
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Interstitial Lung Disease||Drug: Pirfenidone Drug: Placebo||Phase 2|
This is a phase 2, randomized, double blind, placebo controlled trial of pirfenidone for the treatment of RA associated interstitial lung disease. Approximately 270 subjects will be randomized to receive Pirfenidone 2403 mg per day or placebo in a 1:1 ratio. The primary outcome of this study is to assess the efficacy of pirfenidone 2403 mg/day versus placebo in patients with RA associated interstitial lung disease, as defined by progression free survival over the 52 weeks of treatment. Patients will receive blinded study treatment from the time of randomization until the Week 52 Visit.
Eligible patients aged 18 to 85 years must meet 2010 ACR/EULAR criteria for RA (Aletaha, Neogi et al. 2010) as well as RA-associated ILD, as determined by imaging and, when available, lung biopsy. Patients will be required to have a % predicted FVC ≥40 and % predicted DLCO ≥30 at screening.
The dose of study treatment will be titrated over 14 days. Patients will receive a telephone assessment at Weeks 1 and 2, and visit the clinic at Weeks 4, 8, 13, 19, 26, 39, and 52. Subjects will have a follow up phone call 28 days after completion of the study drug. Patients should complete a compliance diary between visits. If patients discontinue study treatment for any reason before the end of the study, they should continue with all scheduled study procedures through Week 52. If subjects are unable to complete the study visits as scheduled, all efforts should be made to complete an early termination visit.
The primary outcome variable of this study will be progression free survival, defined as progression free from decline in FVC of 10% or greater during the 52 week study period.
More information can be found at www.ralung.org.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients With Rheumatoid Arthritis Interstitial Lung Disease (TRAIL1)|
|Actual Study Start Date :||April 7, 2017|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Pirfenidone 2403 mg/d for 52 weeks
Pirfenidone three times daily (2403 mg) for 52 weeks
Other Name: Esbriet
Placebo Comparator: Placebo
Placebo for 52 weeks
Placebo three times daily for 52 weeks
- Incidence of the composite endpoint [ Time Frame: 52 weeks ]Incidence of the composite endpoint of decline in percent predicted FVC of 10% or greater or death.
- Incidence of the composite endpoint [ Time Frame: 52 weeks ]Incidence of the composite endpoint of decline in percent predicted forced vital capacity (FVC) of 10% or greater
- Frequency of progressive disease [ Time Frame: 52 weeks ]Frequency of progressive disease as defined by OMERACT: FVC% relative decline of >=10% or FVC% change in >=5< 10% and >=15% diffusing capacity (DLCO)
- % FVC change stratified by background therapy [ Time Frame: 52 weeks ]
- % FVC change stratified by Usual Interstitial Pneumonitis (UIP) vs. non-UIP pattern on HRCT [ Time Frame: 52 weeks ]
- Change in mean slope of FVC [ Time Frame: 52 weeks ]
- Time to decline of 10% or greater in percent predicted FVC or death [ Time Frame: 52 weeks ]
- All-cause mortality [ Time Frame: 52 weeks ]
- Rate of acute exacerbation of interstitial lung disease (ILD) [ Time Frame: 52 weeks ]
- All-cause hospitalization [ Time Frame: 52 weeks ]
- Hospitalization for respiratory cause [ Time Frame: 52 weeks ]
- Incidence of acute exacerbation of ILD [ Time Frame: 52 weeks ]
- Number of respiratory exacerbations requiring hospitalizations [ Time Frame: 52 weeks ]
- Treatment-emergent Adverse Events (AEs) [ Time Frame: 52 weeks ]
- Treatment-emergent serious adverse events (SAEs) [ Time Frame: 52 weeks ]
- Treatment-emergent/treatment-related AEs [ Time Frame: 52 weeks ]
- Treatment-emergent/treatment-related SAEs [ Time Frame: 52 weeks ]
- AEs leading to early discontinuation of study treatment [ Time Frame: 52 weeks ]
- Treatment-emergent death or transplant [ Time Frame: 52 weeks ]
- Treatment-emergent RA-ILD-related mortality [ Time Frame: 52 weeks ]
- Change from Baseline to Week 52 in dyspnea, as measured by the University of California at San Diego Shortness-of-Breath Questionnaire (UCSD SOBQ) score [ Time Frame: 52 weeks ]
- Change from Baseline to Week 52 on St. George's Respiratory Questionnaire [ Time Frame: 52 weeks ]
- Disease Activity Score (DAS)/Routine assessment of patient index data (RAPID)3 score (RA disease activity scores) [ Time Frame: 52 weeks ]
- Joint counts [ Time Frame: 52 weeks ]
- erythrocyte sedimentation rate (ESR)/c-reactive protein (CRP) [ Time Frame: 52 weeks ]
- Candidate biomarker expression in the peripheral blood of patients with RA-ILD over the 52 weeks of treatment and the study follow-up period [ Time Frame: 52 weeks ]
- Extent and severity of fibrotic lung involvement, as measured by changes in Chest CT scans evaluated by quantitative functional imaging [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808871
|Contact: Ivan Rosas, M.D.||email@example.com|
|Principal Investigator:||Ivan O. Rosas, M.D.||Brigham and Women's Hospital|