Phase ll Study of Pirfenidone in Patients With RAILD

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 18 through 85 years, inclusive, at Screening.
  • Probable or definite diagnosis of RA according to revised 2010 ACR/EULAR criteria, without evidence or suspicion of an alternative diagnosis that may contribute to their interstitial lung disease.
  • Diagnosis of ILD: .
  • No features supporting an alternative diagnosis on transbronchial biopsy, or SLB, if performed prior to Screening.
  • Able to understand and sign a written informed consent form.
  • 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.

Exclusion Criteria:

  • Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator.
  • Cigarette smoking within 3 months of Screening or unwilling to avoid tobacco products throughout the study.
  • 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.
  • Concurrent presence of the following conditions:
    • Other interstitial lung disease, related to but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, or bronchiolitis obliterans organizing pneumonia;
    • Medical history including Human Immunodeficiency Virus (HIV);
    • Medical history of viral hepatitis (positive Hep A antibody in the absence of elevated liver enzymes is not an exclusion).
  • 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.
  • Presence of pleural effusion occupying more than 20% of the hemithorax on Screening HRCT.
  • 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).
  • Coexistent clinically significant COPD/emphysema or asthma in the opinion of the site principal investigator.
  • 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 2 weeks prior to the screening visit. Note that prophylactic antibiotics are not contraindicated or exclusionary.
  • 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.
  • History of end-stage renal disease requiring dialysis.
  • 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. Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone.
  • History of alcohol or substance abuse in the past 2 years, at the time of Screening.
  • Family or personal history of long QT syndrome.
  • Additional exclusions may apply

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrew Limper, M.D.

Open for enrollment

Contact information:

Hope Marlow

(507) 538-3423

Marlow.Hope@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20359112

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