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Trial · NCT05986162

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryIncidence of Treatment Emergent Adverse EventsStudy Week 20Number of subjects with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0
SecondaryMaximum serum concentration of Itolizumab, CmaxStudy Week 16Maximum serum concentration of Itolizumab
SecondaryMinimum serum concentration of Itolizumab, CminStudy Week 16Minimum serum concentration of Itolizumab
SecondaryTime to maximum serum concentration of Itolizumab, TmaxStudy Week 16Time to maximum serum concentration of Itolizumab
SecondaryTotal Itolizumab exposure across time, AUC0-tStudy Week 16Total Itolizumab exposure across time
SecondaryHalf life of Itolizumab, t1/2Study Week 16Half life of Itolizumab
SecondaryIL-2Study Week 16Inflammatory Markers:IL-2
SecondaryIL-6Study Week 16Inflammatory Markers:IL-6
SecondaryTNF-αStudy Week 16Inflammatory Markers: TNF-α
SecondaryIFN-γStudy Week 16Inflammatory Markers:IFN-γ
SecondaryCRPStudy Week 16Inflammatory Markers:CRP
SecondarySerum ferritinStudy Week 16Inflammatory Markers:Serum ferritin
SecondaryESRStudy Week 16Inflammatory Markers:ESR
SecondaryIgGStudy Week 16Inflammatory Markers:IgG
SecondaryIgMStudy Week 16Inflammatory Markers:IgM
SecondaryIgAStudy Week 16Inflammatory Markers: IgA
SecondaryCD6 receptor expression levelsStudy Week 16Mean change of CD6 receptor expression levels in relative to baseline
SecondaryT cell subsetsStudy Week 16Mean change of different proportion of T cell subsets in relative to baseline
SecondaryProportion of patients achieving a TIS of ≥20Study Week 16Defined as patients with an increase of ≥20 points on the Total Improvement Score in relative to baseline.
SecondaryProportion of patients achieving DOIStudy Week 16DOI defined as ≥ 20% improvement in 3 of any 6 core set measures, with no more than 2 core set measures worsening by ≥ 25% (MMT-8 cannot worsen by ≥ 25%).

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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GET https://conductscience.org/api/trials/v1/NCT05986162/registered