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Trial · NCT02808871

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants Who Developed Any Element of the Composite Endpoint52 weeksNumber of participants who developed any element of the composite endpoint of decline in percent predicted FVC of 10% or greater or death.
SecondaryNumber of Participants With FVC Decline From Baseline of 10% or Greater52 weeksNumber of participants with decline from baseline in percent predicted FVC of 10% or greater during the study period.
SecondaryNumber of Participants With Progressive Disease52 weeksNumber of participants with progressive disease as defined by OMERACT: FVC% relative decline of \>=10% or FVC% change in \>=5\< 10% and \>=15% diffusing capacity (DLCO)
SecondaryChange in Absolute Value FVC Over the 52 Week Study Period52 weeksChange from baseline to end of study in absolute value of FVC over the 52 week study period
SecondaryChange in % Predicted FVC From Baseline to End of Study Over the 52 Week Study Period52 weeksChange from baseline to end of study of percent predicted FVC over the 52 week study period
SecondaryTime to Composite of Decline in FVC or Death52 weeksTime to decline of 10% or greater in percent predicted FVC or death while on study
SecondaryChange in PRO of Dyspnea52 weeksChange from Baseline to end of study in dyspnea, as measured by the Dyspnea 12 questionnaire - Total scores range from 0 to 36, with higher scores corresponding to greater severity.
SecondaryAll-cause Mortality52 weeksNumber of participants experiencing mortality due to all causes
SecondaryAll Cause Hospitalization52 weeksNumber of participants requiring hospitalization for any cause
SecondaryHospitalization for Respiratory Cause52 weeksNumber of participants requiring hospitalization for respiratory cause
SecondaryAcute Exacerbations Requiring Hospitalization52 weeksNumber of participants experiencing acute exacerbation requiring hospitalization
SecondaryTreatment-emergent Adverse Events (AEs)52 weeksNumber of participants with treatment-emergent adverse events (AEs)
SecondaryTreatment-emergent Serious Adverse Events (SAEs)52 weeksNumber of participants with treatment-emergent serious adverse events (SAEs) in the as treated population
SecondaryTreatment-emergent/Treatment-related AEs52 weeksNumber of participants with treatment-emergent/treatment-related AEs
SecondaryTreatment-emergent/Treatment-related SAEs52 weeksNumber of participants with treatment-emergent/treatment-related SAEs
SecondaryAEs Leading to Early Discontinuation of Study Treatment52 weeksNumber of participants with AEs leading to early discontinuation of study treatment
SecondaryTreatment-emergent Death or Transplant52 weeksNumber of participants who experienced treatment-emergent death or transplant
SecondaryTreatment-emergent RA-ILD-related Mortality52 weeksNumber of participants who experienced treatment-emergent RA-ILD-related mortality
OtherDisease Activity Score (DAS)52 weeksChange from Baseline to end of study in Disease Activity Score (DAS)
OtherRAPID3 Score52 weeksChange from baseline to end of study in Routine Assessment of Patient Index Data 3 (RAPID3) score

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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