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Trial · NCT04925375

Registered outcomes19

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

ListOutcomeTime frameDescription
PrimaryHigh Resolution CT Scan of the chest (HRCT)6 monthsProportion of subjects achieving a significant response (defined as \>30 percent change in lung tissue disease burden by GLILD) on HRCT after 6 months of abatacept therapy.
SecondaryForced vital capacity (FVC)6 months, 12 monthsForced vital capacity (FVC)
SecondaryForced expiratory volume (FEV)6 months, 12 monthsForced expiratory volume (FEV)
SecondaryDiffusion capacity of carbon monoxide (DLCo)6 months, 12 monthsDiffusion capacity of carbon monoxide (DLCo)
SecondaryIncidence6 months, 12 monthsIncidence of new onset autoimmune/inflammatory diseases while on abatacept or placebo
SecondaryResolution6 months, 12 monthsResolution of existing autoimmune/inflammatory diseases while on abatacept or placebo
SecondaryChange in Short Form-36 scores6 months, 12 monthsShort Form-36: scoring ranges from 0-100 where a higher score denotes better health
SecondaryChange in PedsQL (Pediatric Quality of Life) Generic Core scores6 months, 12 months
PedsQL Generic Core Scales: items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL. Range of 0-2300 for ages above 4, range of 0-2100 for 4 years old
SecondaryChange in King's Interstitial Lung Disease scores6 months, 12 monthsKing's Interstitial Lung Disease: scoring ranges from 0-100 where a higher score denotes better health
SecondarySteroid usage6months, 12 monthsCumulative number of steroids used after 6 months and 12 months
SecondarySurvival6 months, 12 monthsSurvival at 12 months
SecondaryPediatric growth - change in height6 months, 12 monthsChange in height at 6 and 12 months.
SecondaryPediatric growth - change in weight6 months, 12 monthsChange in weight at 6 and 12 months.
SecondaryAdditional Immune Agents6 months, 12 monthsRate of discontinuation of additional immune agents while on study agent
SecondaryAdverse Events/Serious Adverse Events6 months, 12 monthsIncidence of adverse events and severe adverse events, compared to placebo
SecondaryDropout rate6 months, 12 monthsStudy dropout rate
SecondaryIncidence of concurrent infections6 months, 12 monthsIncidence of concurrent infections while on study
SecondaryTreatment of concurrent infections6 months, 12 monthsNumber of infections per patient which require treatment with antibiotics
SecondaryComplications of concurrent infections6 months, 12 monthsComplications of concurrent infections while on study

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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