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Trial · NCT07191444

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryThe proportion of subjects achieving clinical inactive disease (CID) at Week 24, where CID is defined as the absence of Still's disease-related symptoms with normal ESR or CRP levels.At Week 24 from initiation of treatment
SecondaryProportion of subjects achieving afebrile status with either ≥50% reduction in CRP levels or CRP within normal range at Weeks 2, 4, and 8.At Weeks 2, 4, and 8 after treatment initiationEfficacy Endpoints
SecondaryProportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range at Week 12.At Week 12 after treatment initiationEfficacy Endpoints
SecondaryProportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.2 mg/kg/day at Week 12.At Week 12 after treatment initiationEfficacy Endpoints
SecondaryProportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.1 mg/kg/day at Week 12.At Week 12 after treatment initiationEfficacy Endpoints
SecondaryProportion of subjects achieving clinical inactive disease (CID) with discontinuation of glucocorticoidsAt Week 24 after treatment initiationEfficacy Endpoints
SecondaryProportion of subjects without disease relapse at Weeks 12 and 24.At Weeks 12 and 24 after treatment initiationEfficacy Endpoints
SecondaryACR30, ACR50, ACR70, and ACR90 response rates at Weeks 2, 4, 8, 12, 16, 20, and 24.At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiationEfficacy Endpoints
SecondaryChange from baseline in ferritin levels at Weeks 2, 4, 8, 12, 16, 20, and 24.At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiationEfficacy Endpoints
SecondaryChange from baseline in cytokine levels (including sIL-2R) at Weeks 2, 4, 8, 12, 16, 20, and 24.At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiationEfficacy Endpoints
SecondaryChange from baseline in ESR at Weeks 2, 4, 8, 12, 16, 20, and 24.At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiationEfficacy Endpoints
SecondaryChange from baseline in CRP levels at Weeks 2, 4, 8, 12, 16, 20, and 24At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiationEfficacy Endpoints
SecondaryChange from baseline in Pouchot score at Weeks 2, 4, 8, 12, 16, 20, and 24.At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiationEfficacy Endpoints. Pouchot score ranges from 0 to 12 points, with higher scores indicating a poorer outcome.
SecondaryChange from baseline in glucocorticoid dose at Weeks 2, 4, 8, 12, 16, 20, and 24.At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiationEfficacy Endpoints
SecondaryNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0Through study completion, an average of 1 year

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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