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Trial · NCT06367283

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryFinger painWeek 16Change from baseline in Visual Analogue Scale (VAS) finger joint pain of the target hand after 16 weeks of treatment
SecondaryFunctionWeek 16Change from baseline after 16 weeks of treatment in physical function assessed by Australian/Canadian Osteoarthritis Hand Index (AUSCAN) physical function subscale
SecondaryThumb base painWeek 16Change from baseline after 16 weeks of treatment in Visual Analogue Scale thumb base pain of the target hand
SecondaryHand painWeek 16Change from baseline after 16 weeks of treatment in pain of both hands assessed by Australian/Canadian Osteoarthritis Hand Index hand pain subscale
SecondaryPhysician tender joint countWeek 16Change from baseline after 16 weeks of treatment in joint activity of the target hand assessed by physician tender joint count
SecondaryPatient global assessmentWeek 16Change from baseline after 16 weeks of treatment in Visual Analogue Scale patient global assessment
SecondaryQuality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scaleWeek 16Change from baseline after 16 weeks of treatment in quality of life assessed by the European Quality of life - 5 dimensions scale
SecondaryHand strengthWeek 16Change from baseline after 16 weeks of treatment in hand strength of the target hand assessed by a grip dynamometer
SecondaryNumber of treatment respondersWeek 16
Responders will be identified according to OMERACT-OARSI criteria, defined as (1) improvement in finger pain (primary outcome) or function (secondary outcome) ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three: finger pain (primary outcome), function (secondary outcome), and patient global assessment (secondary outcome).
OtherStiffness of both handsWeek 16Change in stiffness of both hands measured on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) stiffness subscale
OtherComposite of pain, function and stiffnessWeek 16Change in pain, function and stiffness of both hands measured composite on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) Hand Index Score
OtherPhysical functionWeek 16Change in physical function of both hands assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI)
OtherPhysician global assessmentWeek 16Change in physician global assessment of disease activity of hand OA in the target hand measured on a Visual Analogue Scale (VAS) scale
OtherSwollen joint countWeek 16Change in physician swollen joint count of the target hand
OtherFatigueWeek 16Change in fatigue measured on a Visual Analogue Scale (VAS) scale
OtherSleep qualityWeek 16Change in sleep quality measured on the Pittsburgh Sleep Quality Index (PSQI)
OtherAbsence or presence of inflammation of target handWeek 16Change in absence or presence of inflammation of the target hand as measured by ultrasound (US)
OtherChange in use of analgesicsWeek 16Change in use of analgesics measured as the use of paracetamol and NSAIDS
OtherInflammatory biomarkerWeek 16Change in hsCRP mg/L
OtherMetabolic outcomesWeek 16Change in HbA1c mmol/mol

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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