Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

Inclusion Criteria:

Diagnosis of systemic sclerosis-related (SSc) confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis less than (<) 7 years
Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan
Screening forced vital capacity (FVC) greater than equal to (>=) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (DLCO) >=40% of the predicted value
At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate

Exclusion Criteria:

Clinically significant pulmonary hypertension
Known underlying liver disease
Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux
History of clinically significant asthma or chronic obstructive pulmonary disease
Active infection
Diagnosis of another connective tissue disorder
Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention
History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD)
Pregnancy or lactation
Creatinine clearance <40 milliliters per minute (mL/min)
Prior use of pirfenidone
Unsuitable for enrollment or unlikely to comply with study requirements