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Trial · NCT05803135

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryThe percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28week 24
The proportion of patients with DAS28-CRP\<2.6 at the end of 24 weeks was compared between the two groups. The DAS28 is a composite score derived from 4 of these measures,that is the count of tender joint count(TJC, 0-28)and swollen joint count(SJC, 0-28), measure C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity.
SecondaryPercentage of American College of Rheumatology [ACR] 20 Criteria Responders at the end of 24 weeks was compared between the two groups.week 24Percentage of American College of Rheumatology \[ACR\] 20 Criteria Responders at the end of 24 weeks was compared between the two groups.
SecondaryPercentage of American College of Rheumatology [ACR] 50 Criteria Responders at the end of 24 weeks was compared between the two groups.week 24Percentage of American College of Rheumatology \[ACR\] 50 Criteria Responders at the end of 24 weeks was compared between the two groups.
SecondaryPercentage of American College of Rheumatology [ACR] 70 Criteria Responders at the end of 24 weeks was compared between the two groups.week 24Percentage of American College of Rheumatology \[ACR\] 70 Criteria Responders at the end of 24 weeks was compared between the two groups.
SecondaryThe change of DAS28 score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)up to week 24The change of DAS28 score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)
SecondaryThe change of Clinical Disease Activity Index (CDAI) score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)up to week 24
The CDAI is a composite score derived from these measures,that is the count of tender joint count(TJC, 0-28), swollen joint count(SJC, 0-28), Patient global assessment(PGA)and physician global assessment(PHGA), each of the last two was CDAI score will be calculated with formula CDAI = TJC + SJC + PGA + PHGA. CDAI \> 22 is considered high disease activity; 10 \<CDAI ≤ 22, moderate disease activity; 2.8 \<CDAI ≤10, low disease activity; remission is CDAI score ≤2.8.
SecondaryThe change of Simplified Disease Activity Index (SDAI) score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)up to week 24
The SDAI is a composite score derived from these measures,that is the count of tender joint count(TJC, 0-28), swollen joint count(SJC, 0-28), C-reactive protein (CRP, mg/L), Patient global assessment(PGA)and physician global assessment(PHGA), each of the last two was assessed on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease. SDAI score will be calculated with formula SDAI = TJC + SJC + PGA+PHGA+ CRP. SDAI score exceeding 26 is considered high disease activity; 11 \<SDAI ≤26,moderate disease activity; 3.3 \<SDAI ≤11, low disease activity; remission is SDAI score ≤ 3.3.
SecondaryThe percentage of patients who achieve clinical remission at week 12 using European League Against Rheumatism (EULAR) response criteria DAS28week 12
The proportion of patients with DAS28-CRP\<2.6 at the end of 12 weeks was compared between the two groups. The DAS28 is a composite score derived from 4 of these measures,that is the count of tender joint count(TJC, 0-28)and swollen joint count(SJC, 0-28), measure C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity.
SecondaryThe proportion of patients with SDAI≤3.3 at the end of 24 weeks was compared between the two groups.week 24The proportion of patients with SDAI≤3.3 at the end of 24 weeks was compared between the two groups.
SecondaryThe proportion of patients with CDAI≤2.8 at the end of 24 weeks was compared between the two groups.week 24The proportion of patients with CDAI≤2.8 at the end of 24 weeks was compared between the two groups.
SecondaryThe changes of ACPA, RF, serum immunoglobulin (IgG, IgA, IgM) levels between the two groups at the end of 24 weeks were compared with the baseline values (week 0).up to week 24The changes of ACPA, RF, serum immunoglobulin (IgG, IgA, IgM) levels between the two groups at the end of 24 weeks were compared with the baseline values (week 0).
SecondaryThe drug retention rate was compared between the two groups at the end of 12 and 24 weeks.week 12 and 24The drug retention rate was compared between the two groups at the end of 12
Secondary
The proportion of patients with minimal clinically important difference (MCID) of 0.22 on the Health Assessment Questionnaire Disability Index (HAQ-DI) was compared between the two groups at the end of 24 weeks.
week 24
The proportion of patients with minimal clinically important difference (MCID) of 0.22 on the Health Assessment Questionnaire Disability Index (HAQ-DI) was compared between the two groups at the end of 24 weeks.
Other
The change of EULAR Sjögren's Syndrome Discasc Activity Index (ESSDAI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0)
up to week 24
The change of EULAR Sjögren's Syndrome Discasc Activity Index (ESSDAI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0)
Other
The change of EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0)
up to week 24
The change of EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0)
OtherNumber of participants with"adverse events (AEs)"up to week 24
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with"adverse events (AEs)"i.e. physical exam abnormalities,vital sign abnormalities,laboratory value abnormalities,symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product.

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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