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

Overview

Información sobre este estudio

PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in patients with systemic sclerosis−related interstitial lung disease (SSc-ILD).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  1. Diagnosis of SSc confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis <7 years
  2. Diagnosis of SSc-ILD based on an HRCT scan
  3. Screening FVC ≥50% of the predicted value, and screening DLCO ≥40% of the predicted value
  4. At study entry, the patient either is not taking SSc-ILD medication or is taking cyclophosphamide or mycophenolate mofetil

Exclusion Criteria:

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

More information

Publicaciones

  • A multicenter, ongoing study of early-diagnosed cases of systemic sclerosis and comparison patients with systemic lupus erythematosus, polymyositis/dermatomyositis, and Raynaud's phenomenon was conducted in order to develop classification criteria for systemic sclerosis. Preliminary criteria are proposed namely, the finding of either the sole major criterion, i.e., proximal scleroderma, or two or more of the minor criteria, i.e., 1) sclerodactyly, 2) digital pitting scars of fingertips or loss of substance of the distal finger pad, and 3) bilateral basilar pulmonary fibrosis. When applied to the case and comparison patients included in this study, these proposed criteria had a 97% sensitivity for definite systemic sclerosis and 98% specificity. Read More on PubMed

Otros temas en investigación

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CLS-20491132

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