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Trial · NCT03710941

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryPercent change in total lean mass as measured by dual-energy X-ray absorptiometry (DXA)Up to Week 20
SecondaryChange in the Inclusion Body Myositis-Functional Rating Scale (IBM-FRS)Up to Week 26
SecondaryChange in the Sporadic inclusion body myositis (sIBM) Physical Functioning Assessment (sIFA)Up to Week 26
SecondaryIncidence and severity of treatment-emergent adverse events (TEAEs)Up to Week 30
SecondaryPercent change in total and regional body composition (including lean mass and fat mass) as measured by DXAUp to Week 30
SecondaryAbsolute change in total and regional body composition (including lean mass and fat mass) as measured by DXAUp to Week 30
SecondaryChange in the 1-repetition maximum (1-RM) chest press strengthUp to Week 26
SecondaryChange in hand-grip strength as measured by dynamometryUp to Week 26
SecondaryChange in distance walked in the 6-minute walk test (6MWT)Up to Week 26
SecondaryChange in time to complete the 10-meter walk test (10MWT)Up to Week 26
SecondaryChange in instrumented stair climb powerUp to Week 26
SecondaryChange in instrumented, sensor-based sit-to-stand test timeUp to Week 26
SecondaryChange in fear of falling as measured via the Falls Efficacy Scale-International (FES-I)Up to Week 30
SecondaryChange in Patient Global Impression of Severity assessments (PGIS/PGIC)Up to Week 30
SecondaryChange in Patient Global Impression of Change Items assessments (PGIS/PGIC)Up to Week 30
SecondaryChange in Clinician Global Impression of Severity assessments (CGIS/CGIC)Up to Week 30
SecondaryChange in Clinician Global Impression of Change Items assessments (CGIS/CGIC)Up to Week 30
SecondaryChange in 36-item Short Form Health Survey (SF-36), including the Physical Function Items (PF-10) and the Vitality Scale of the SF-36Up to Week 30
SecondaryChange in Thigh muscle volume as measured by MRI (sub-study)Up to Week 30
SecondaryFrequency of falls and near-falls as measured by the Hopkins Falls Grading ScaleUp to Week 30

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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