Phase 2 Rheumatoid Arthritis Trial, Completed

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 85 years old at the time of screening
• People who have been diagnosed with rheumatoid arthritis (RA) according to recognised 2010 diagnostic standards, with no signs of another condition that could be causing their lung disease
• People who have been diagnosed with interstitial lung disease (ILD) — a type of scarring or inflammation in the lungs — confirmed by a specialised lung scan (HRCT), and where available, a surgical lung biopsy
• People whose lung scans show scarring affecting more than 10% of the lung tissue, confirmed before the study begins
• People whose lung scan results do not show signs of another diagnosis on any biopsy performed before screening
• People whose breathing test results meet specific standards: lung capacity (FVC) at least 40% of what is expected for their age and size; a gas transfer measurement (DLCO or TLCO) of at least 25% of expected; and breathing test results that are consistent and meet quality standards between two visits
• People who are able to understand and sign a consent form
• Women who could become pregnant must agree to use two reliable methods of contraception (at least one with a failure rate of less than 1% per year), or remain abstinent from heterosexual intercourse, throughout the 52-week treatment period and for at least 118 days after the last dose of study medication
• Men who have not had a surgical sterilisation procedure must agree to use a condom plus an additional reliable contraceptive method (together giving a failure rate of less than 1% per year), or remain abstinent, during treatment and for at least 118 days after the last dose; they must also agree not to donate sperm during this time

Who may not be able to join:

• People the trial investigator considers unsuitable or unlikely to follow the study requirements
• People who have smoked cigarettes or used vaping products within the 3 months before screening, or who are unwilling to avoid tobacco products during the study
• People with a history of significant exposure to substances known to cause lung scarring, such as certain medications (for example, amiodarone), asbestos, beryllium, radiation, or domestic birds
• People who also have another type of interstitial lung disease (such as sarcoidosis, hypersensitivity pneumonitis, or lung disease caused by radiation or drugs)
• People with a medical history of HIV
• People with a medical history of viral hepatitis (though a positive hepatitis A antibody result alone, without raised liver enzyme levels, does not exclude someone)
• People who have other lung or chest conditions related to RA, such as rheumatoid nodules in the lung, inflammation of the lining of the lungs, or obliterative bronchiolitis
• People whose breathing test shows a specific airflow pattern (FEV1/FVC below 0.65) suggesting airway obstruction
• People whose lung scan shows a fluid collection around the lung taking up more than 20% of the chest cavity
• People who have been diagnosed with a second connective tissue disease or overlap syndrome, such as scleroderma, Sjögren's syndrome, lupus, or polymyositis/dermatomyositis (Raynaud's phenomenon alone does not exclude someone)
• People with significant chronic obstructive pulmonary disease (COPD), emphysema, or asthma, as judged by the trial investigator
• People with signs of an active infection (such as pneumonia, bronchitis, or urinary tract infection) — any infection must be fully resolved, and any antibiotic treatment must have been completed at least 2 weeks before the screening visit (note: preventive antibiotics do not exclude someone)
• People who have had any cancer diagnosed within the past 5 years, with some exceptions: skin basal cell carcinoma, skin squamous cell carcinoma, low-grade cervical carcinoma, and certain very low- or low-risk prostate cancers that meet specific criteria and are being monitored without treatment may be considered on a case-by-case basis (confirm with trial site)
• People with a history of abnormal liver function test results, or other evidence of liver damage or cirrhosis that could interfere with how the study drug is processed by the body — specific liver enzyme levels are assessed (confirm with trial site for exact thresholds); people with a condition called Gilbert's syndrome are not excluded based on bilirubin alone
• People with a history of kidney failure requiring dialysis
• People with unstable or worsening heart disease, an unstable heart rhythm, a heart attack in the past year, or heart failure requiring a hospital admission
• People with any condition that the investigator believes could be significantly worsened by the known side effects of pirfenidone (the study drug)
• People with a history of alcohol or substance misuse in the past 2 years at the time of screening
• People with a personal or family history of a heart rhythm condition called long QT syndrome
• People whose kidney function test (eGFR) result is below 30 mL/min/1.73m², or whose heart tracing (ECG) shows a QTc interval above 500 milliseconds at screening
• People who have previously used pirfenidone, or who are known to be allergic to any ingredient in the study treatment
• People who have used certain medications within 28 days before screening or during the study, including: unapproved investigational drugs; strong inhibitors of a liver enzyme called CYP1A2 (such as fluvoxamine or enoxacin); strong activators of CYP1A2; or daily use of sildenafil (occasional use for erectile dysfunction is permitted)
• People whose dose of corticosteroids or immune-suppressing or anti-inflammatory medications for their lung condition has been started or changed within 3 months before screening — however, changes made to manage non-lung RA symptoms do not exclude someone; small adjustments to corticosteroid doses kept at or below 20 mg prednisone daily (or equivalent) are also permitted
• People who have used any approved anti-fibrotic (anti-scarring) medication within 28 days before screening

Important: Always verify eligibility with the trial site directly before applying.