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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Diagnosis of Interstitial Lung Disease: 1. Age 18 through 85 years, inclusive, at screening 2. Diagnosis of RA according to revised 2010 ACR/EULAR criteria 3. Diagnosis of ILD 1. Supported by clinically indicated HRCT, and when available surgical lung biopsy (SLB). 2. Presence of reticular abnormality affecting more than 10% of the lung parenchyma, with or without traction bronchiectasis or honeycombing, on HRCT 4. No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or SLB, if performed 5. Attainment of the following centralized spirometry criteria (based on local spirometry on standardized equipment and centralized quality controlled): 1. % predicted FVC ≥ 40% at Screening 2. Change in pre- and post-bronchodilator FVC (measured in liters) between Screening (Visit 1) and Visit 2 must be a <10% relative difference, calculated as shown below: Screen FVC (L)
  • - Day 1 FVC (L) × 100% Screen FVC (L) 3.
%predicted DLCO ≥ 30% at Screening Informed Consent and Protocol Adherence: 6. Able to understand and sign a written informed consent form 7. Pregnancy or lactation. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year, during the 52 week treatment period and for at least 118 days after the last dose of study drug. 8. For men who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.

Exclusion Criteria:

Disease-Related Exclusions: 1. Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator 2. Cigarette smoking within 3 months of Screening or unwilling to avoid tobacco products throughout the study 3. History of clinically significant environmental exposure known to cause pulmonary fibrosis (PF), including but not limited to drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds 4. Concurrent presence of the following conditions: 1. other interstitial lung disease, related to but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, 2. Medical history including Human Immunodeficiency Virus (HIV), 3. Medical history of viral hepatitis (positive Hep A antibody in the absence of elevated liver enzymes is not an exclusion) 5. Concurrent presence of other pleuropulmonary manifestations of RA, including but not limited to rheumatoid nodular disease of the lung, pleuritis/pleural thickening, and obliterative bronchiolitis 6. Post-bronchodilator FEV1/FVC < 0.7 7. Presence of pleural effusion occupying more than 20% of the hemithorax 8. Clinical diagnosis of a second connective tissue disease or overlap syndrome (including but not limited to scleroderma, sjogren's,polymyositis/dermatomyositis, systemic lupus erythematosus, but excluding Raynaud's phenomena) 9. Coexistent clinically significant COPD/emphysema or asthma in the opinion of the site principle investigator Medical Exclusions: 10. Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis. The infection should be resolved per PI assessment prior to enrollment. Any use of antibiotics must be completed 4 2weeks prior to the screening visit. Note that prophylactic antibiotics are not contraindicated or exclusionary. 11. Any history of malignancy diagnosed within 5 years of screening, other than basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or low grade cervical carcinoma in situ. 12. History of LFT abnormalities as outlined below, or imaging, laboratory or other clinical information suggesting liver dysfunction, advanced liver disease or cirrhosis. Evidence of hepatic impairment that in the opinion of the investigator could interfere with drug metabolism or increase the risk of the known hepatotoxicity of study drug. Any of the following liver function abnormalities: 1. Total bilirubin above the upper limit of normal (ULN), excluding patients with Gilbert's syndrome; 2. Aspartate or alanine aminotransferase (AST/SGOT or AST/SGPT) > 3 X ULN; 3. Alkaline phosphatase > 2.5 X ULN. 13. History of end-stage renal disease requiring dialysis 14. History of unstable or deteriorating cardiac disease, or unstable cardiac arrhythmia or arrhythmia requiring modification of drug therapy, myocardial infarction within the previous year, heart failure requiring hospitalization. 15. Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone 16. History of alcohol or substance abuse in the past 2 years, at the time of screening 17. Family or personal history of long QT syndrome. Laboratory Exclusions: 18. Any of the following test criteria above specified limits: 1. Estimated glomerular filtration rate < 57 2. Electrocardiogram (ECG) with a QTc interval >500 msec at Screening Medication Exclusions: 19. Prior use of pirfenidone or known hypersensitivity to any of the components of study treatment 20. Use of any of the following therapies within 28 days before Screening and during participation in the study: 1. Investigational therapy, defined as any drug that has not been approved for marketing for any indication in the country of the participating site 2. Potent inhibitors of CYP1A2 (e.g. fluvoxamine, enoxacin) 3. Sildenafil (daily use). Note: intermittent use for erectile dysfunction is allowed 21. Introduction and/or modification of dose of corticosteroids or any cytotoxic, immunosuppressive, or cytokine modulating or receptor antagonist agent for the management of pulmonary manifestations of RA, within 3 months of screening, is an exclusion criterion, for enrollment, with the exception of dose modification of systemic corticosteroids that are maintained at or below 20 mg prednisone daily or the equivalent. 22. Any use of an approved anti-fibrotic medication. However, introduction and/or modification of dose of corticosteroids or any cytotoxic, immunosuppressive, or cytokine modulating or receptor antagonist agent for the management of extrapulmonary manifestations of RA is not an exclusion criterion for enrollment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02808871
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ivan O. Rosas
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ivan O. Rosas, M.D.
Principal Investigator Affiliation Brigham and Women's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Australia, Canada, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis Interstitial Lung Disease
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Washington, Seattle, Washington

Status

Recruiting

Address

University of Washington

Seattle, Washington, 98195

Site Contact

Ganesh Raghu, MD

graghu@uw.edu

206-598-4967

University of Utah Health Care, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Health Care

Salt Lake City, Utah, 84132

Site Contact

Mary Beth Scholand, M.D

scholand@genetics.utah.edu

801-581-7806

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

Lisa H. Lancaster, M.D.

lisa.lancaster@vanderbilt.edu

615-322-5879

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44106

Site Contact

Kristin Highland, MD

highlak@ccf.org

216-445-0574

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10065

Site Contact

Robert Kaner, MD

rkaner@med.cornell.edu

646-962-2333

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Andrew Limper, M.D.

limper.andrew@mayo.edu

507-284-4162

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Kevin R. Flaherty, M.D.

flaherty@umich.edu

734-647-9342

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Paul Dellaripa, MD

pdellaripa@bwh.harvard.edu

617-732-5548

John Hopkins Medicine, Baltimore, Maryland

Status

Recruiting

Address

John Hopkins Medicine

Baltimore, Maryland, 21224

Site Contact

Karthik Suresh, M.D.

ksuresh2@jhmi.edu

410-550-2062

Tulane Medical Center, New Orleans, Louisiana

Status

Recruiting

Address

Tulane Medical Center

New Orleans, Louisiana, 70112

Site Contact

Joseph A. Lasky, M.D.

jlasky@tulane.edu

504-988-8600

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Marilyn Glassberg, MD

ESimonet@med.miami.edu

305-243-3728

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Site Contact

Jeffrey J. Swigris, D.O., M.S.

swigrisj@njhealth.org

303-875-7541

University of Alabama Site at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama Site at Birmingham

Birmingham, Alabama, 35294

Site Contact

Joao DeAndrade, MD

jdeandrade@uabmc.edu

205-934-4328

International Sites

Southhampton, United Kingdom

Status

Recruiting

Address

University Hospital Southampton NHS Foundation Trust

Southhampton, , SO16 6YD

Site Contact

Sophie Fletcher, MD

Sophie.fletcher@uhs.nhs.uk

023 8077 7222

Oxford, United Kingdom

Status

Recruiting

Address

Oxford University Hospitals NHS Foundation Trust

Oxford, , OX3 7LE

Site Contact

Rachel Hoyles, MD

Hoyles@ouh.nhs.uk

0300 304 7777

Norwich, United Kingdom

Status

Recruiting

Address

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, , NR4 7UY

Site Contact

Andrew Wilson, MD

a.m.wilson@uea.ac.uk

01603 286286

Newcastle Upon Tyne, United Kingdom

Status

Recruiting

Address

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle Upon Tyne, , NE1 4LP

Site Contact

Ian Forrest, MD

ian.forrest@nuth.nhs.uk

0191 233 6161

Manchester, United Kingdom

Status

Recruiting

Address

Manchester University NHS Foundation Trust (South) Wythenshawe Hospita

Manchester, , M23 9LT

Site Contact

Nazia Chaudhuri, MD

nazia.chaudhuri@nhs.net

0161 998 7070

London, United Kingdom

Status

Recruiting

Address

Royal Brompton and Harefield NHS Foundation Trust

London, , SW3 6NP

Site Contact

Toby Maher, MD

T.Maher@rbht.nhs.uk

02073528121

Liverpool, United Kingdom

Status

Recruiting

Address

Aintree University Hospitals NHS Foundation Trust

Liverpool, , L9 7AL

Site Contact

Lisa Spencer, MD

Lisa.spencer@aintree.nhs.uk

0151 529 2077

Leicester, United Kingdom

Status

Recruiting

Address

University Hospitals of Leicester NHS Foundation Trust

Leicester, , LE3 9QP

Site Contact

Bibek Goopta, MD

bibek.gooptu@uhl-tr.nhs.uk

0116 258 3325

Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

Status

Recruiting

Address

Leeds Teaching Hospitals NHS Trust

Leeds, , LS9 7TF

Site Contact

Paul Beirne, MD

p.beirne@nhs.net

0113 206 5113

Royal Devon and Exeter NHS Foundation, Exeter, United Kingdom

Status

Recruiting

Address

Royal Devon and Exeter NHS Foundation

Exeter, , EX2 5DW

Site Contact

Michael Gibbons, MD

Michael.gibbons2@nhs.net

01392 411 611

Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom

Status

Recruiting

Address

Papworth Hospital NHS Foundation Trust

Cambridge, , CB23 3RE

Site Contact

Helen Parfrey, MD

helen.parfrey@papworth.nhs.uk

01480 364521

Bristol, United Kingdom

Status

Recruiting

Address

North Bristol NHS Trust Headquarters, Southmead Hospital

Bristol, , BS10 5NB

Site Contact

Huzaifa Adamali, MD

Huzaifa.Adamali@nbt.nhs.uk

07530 426423

Toronto General Hospital, Toronto, Ontario, Canada

Status

Recruiting

Address

Toronto General Hospital

Toronto, Ontario, M5G 2C4

Site Contact

Shane Shapera, MD

Shane.Shapera@uhn.ca

416-581-8586

St. Joseph's Healthcare, Hamilton, Ontario, Canada

Status

Recruiting

Address

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6

Site Contact

Gerard Cox, MD

coxp@mcmaster.ca

905-522-1155 #35003

Vancouver, British Columbia, Canada

Status

Recruiting

Address

St. Paul's Hospital - Providence Health Care

Vancouver, British Columbia, V6Z1Y6

Site Contact

Chris Ryerson, MD

Chris.Ryerson@hli.ubc.ca

604-682-2344 #62489

Calgary, Alberta, Canada

Status

Recruiting

Address

University of Calgary Cummings School of Medicine

Calgary, Alberta, T3M 1M4

Site Contact

Charlene D. Fell, MD

Charlene.Fell@albertahealthservices.ca

403-956-3826

Melbourne Alfred Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

Melbourne Alfred Hospital

Melbourne, Victoria, 3004

Site Contact

Ian Glasspole, MD

i.glaspole@alfred.org.au

61 3 9076 6963

Royal Prince Alfred Hospital, Camperdown, Sydney, Australia

Status

Recruiting

Address

Royal Prince Alfred Hospital

Camperdown, Sydney, NSW 2050

Site Contact

Lauren Troy, MD

Troy@health.nsw.gov.au

9515 5006

The Prince Charles Hospital, Chermside, Brisbane, Australia

Status

Recruiting

Address

The Prince Charles Hospital

Chermside, Brisbane, QLD 4032

Site Contact

Daniel Chambers, MD

Daniel.Chambers@health.qld.gov.au

+61 7 3139 4000

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