Trial · NCT04928066
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The percentage of patients who achieve clinical remission at week 30 using European League Against Rheumatism (EULAR) response criteria DAS28 | week 30 | The percentage of patients whose Disease Activity Score in 28 Joints (DAS28) achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2). 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 erythrocyte sedimentation rate (ESR, mm/h) or C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity i.e. 'global assessment of health' (GH) using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst. DAS28 values were calculated as follows: DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x GH. High disease activity: DAS28-ESR \> 5.1; Moderate disease activity: 5.1≥ DAS28 \> 3.2 to 5.1; Low disease activity (LDA) and Remission mean Clinical remission. |
| Secondary | The percentage of patients who achieve clinical remission using DAS28-ESR at week 18 | week 18 | The percentage of patients whose DAS28 achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2) at week 18. |
| Secondary | The percentage of patients who achieve clinical remission using DAS28-ESR at week 6 | week 6 | The percentage of patients whose DAS28 achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2) at week 18. |
| Secondary | Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 30 | week 30 | △DAS28 indicates the decline of DAS28-ESR from the baseline to week 30. EULAR response states were classified as follows: good responders were patients with an improvement from baseline (△DAS28-ESR) of \> 1.2 and a DAS28-ESR at week 30 ≤ 3.2. Moderate responders: △DAS28 \> 1.2 and still DAS28 \> 3.2 at week 30, or 1.2 ≥△DAS28 \> 0.6 and DAS28 ≤ 5.1 at week 30. Nonresponders：△DAS28 ≤0.6 or DAS28 \>5.1 at week 30. DAS28-defined remission was classified as a score of \<2.6. |
| Secondary | Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 18 | week 18 | EULAR response states were classified as follows: DAS28-ESR Good responders: △DAS28 \> 1.2 and DAS28 ≤3.2 at week 18. Moderate responders：△DAS28 \> 1.2 and still DAS28 \> 3.2 at week 18; or 1.2 ≥△DAS28 \> 0.6 and DAS28 ≤ 5.1 at week 18. Nonresponders：△DAS28 ≤0.6，or DAS28 \>5.1 at week 18. DAS28-defined remission was classified as a score of \<2.6. |
| Secondary | Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 6 | week 6 | EULAR response states were classified as follows: DAS28-ESR Good responders: △DAS28 \> 1.2 and DAS28 ≤3.2 at week 6. Moderate responders：△DAS28 \> 1.2 and still DAS28 \> 3.2 at week 6; or 1.2 ≥△DAS28 \> 0.6 and DAS28 ≤ 5.1 at week 6. Nonresponders：△DAS28 ≤0.6，or DAS28 \>5.1 at week 6. DAS28-defined remission was classified as a score of \<2.6. |
| Secondary | Percentage of participants achieving ACR/EULAR remission at week 30 | week 30 | If all of the following 4 parameters are fulfilled, it is defined as remission: TJC ≤ 1, SJC ≤ 1, CRP ≤ 1 mg/dL, Patient global assessment（PGA） ≤ 1 cm (on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease). |
| Secondary | Percentage of participants achieving ACR/EULAR remission at week 18 | week 18 | If all of the following 4 parameters are fulfilled, it is defined as remission: TJC ≤ 1, SJC ≤ 1, CRP ≤ 1 mg/dL, Patient global assessment（PGA） ≤ 1 cm (on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease). |
| Secondary | Percentage of participants achieving ACR/EULAR remission at week 6 | week 6 | If all of the following 4 parameters are fulfilled, it is defined as remission: TJC ≤ 1, SJC ≤ 1, CRP ≤ 1 mg/dL, Patient global assessment（PGA） ≤ 1 cm (on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease). |
| Secondary | Change from baseline Simplified Disease Activity Index (SDAI) | up to week 30 | 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. |
| Secondary | Change from baseline Clinical Disease Activity Index (CDAI) | up to week 30 | Change from baseline Clinical Disease Activity Index (CDAI) 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. |
| Secondary | Change From Baseline in C-reactive Protein (CRP) | up to week 30 | Change from Baseline in C-reactive Protein (CRP), a component index of ACR20 and SDAI, CRP will be measured with blood samples. |
| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | up to week 30 | Change from Baseline in ESR, that is a component index of ACR20, DAS28-ESR and SDAI, ESR will be measured with blood samples. |
| Secondary | Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI) | up to week 30 | Change from Baseline in HAQ-DI, a participant assessed measure of health assessment, shaveing eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item on a single scale has 4 degrees ranging from 0 (no functional difficulty) to 3 (unable to do), with higher scores indicating severe disease. |
| Secondary | Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every time | up to week 30 | Percentage of American College of Rheumatology \[ACR\] 20 Criteria Responders every time |
| Secondary | Incidence of participant withdrawal | up to week 30 | Percentage of participants who withdraw from this study. |
| Secondary | Number of participants with"adverse events (AEs)" | up to week 30 | 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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