Trial · NCT07115641
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of subjects achieving ACR20 | At the end of the treatment (on the 84th day) | ACR20: The improvement degree of the number of tender joints and the number of swollen joints is ≥20%, and the improvement degree of at least 3 items among the remaining 5 items is ≥20%. |
| Secondary | The change of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP） score compared with the baseline | At the end of the treatment (on the 84th day) | DAS28-CRP=0.56×sqrt（TJC28）+0.28×sqrt（SJC28）+0.36×ln（CRP+1）+0.014×GH+0.96 * TJC28: Number of tender joints among 28 joints; * SJC28: Number of swollen joints among 28 joints; * ESR: Erythrocyte Sedimentation Rate; * CRP: C-reactive Protein; * GH: Patient's global assessment of disease activity (VAS score, unit: 100mm). Disease activity DAS28-CRP thresholds: * High: \> 4.1; * Moderate: \> 2.7 and ≤ 4.1; * Low: \> 2.3 and ≤ 2.7; * Remission: ≤ 2.3 |
| Secondary | The proportion of subjects achieving ACR20 | By the 28th day of treatment | ACR20: The improvement degree of the number of tender joints and the number of swollen joints is ≥20%, and the improvement degree of at least 3 items among the remaining 5 items is ≥20%. |
| Secondary | The change of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP） score compared with the baseline | By the 28th day of treatment | DAS28-CRP=0.56×sqrt（TJC28）+0.28×sqrt（SJC28）+0.36×ln（CRP+1）+0.014×GH+0.96 - TJC28: Number of tender joints among 28 joints; - SJC28: Number of swollen joints among 28 joints; - ESR: Erythrocyte Sedimentation Rate; - CRP: C-reactive Protein; - GH: Patient's global assessment of disease activity (VAS score, unit: 100mm). Disease activity DAS28-CRP thresholds: - High: \> 4.1; - Moderate: \> 2.7 and ≤ 4.1; - Low: \> 2.3 and ≤ 2.7; - Remission: ≤ 2.3 |
| Secondary | The remission rate of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP） | When treating up to the 28th and 84th days | |
| Secondary | The low activity rate of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP） | When treating up to the 28th and 84th days | |
| Secondary | The remission rate of Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate（DAS28-ESR） | When treating up to the 28th and 84th days | |
| Secondary | The low activity rate of Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate（DAS28-ESR） | When treating up to the 28th and 84th days | |
| Secondary | The change of Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate（DAS28-ESR） score compared with the baseline | When treating up to the 28th and 84th days | DAS28-ESR=0.56×sqrt（TJC28）+0.28×sqrt（SJC28）+0.70×ln（ESR）+0.014×GH * TJC28: Number of tender joints among 28 joints; * SJC28: Number of swollen joints among 28 joints; * ESR: Erythrocyte Sedimentation Rate; * CRP: C-reactive Protein; * GH: Patient's global assessment of disease activity (VAS score, unit: 100mm). Disease activity DAS28-ESR thresholds: * High: \> 5.1; * Moderate: \> 3.2 and ≤ 5.1; * Low: \> 2.6 and ≤ 3.2; * Remission: ≤ 2.6 |
| Secondary | The proportion of subjects with ACR50 | When treating up to the 28th and 84th days | ACR50: The improvement degree of the number of tender joints and the number of swollen joints is ≥50%, and the improvement degree of at least 3 items among the remaining 5 items is ≥50%. |
| Secondary | The proportion of subjects with ACR70 | When treating up to the 28th and 84th days | ACR70: The improvement degree of the number of tender joints and the number of swollen joints is ≥70%, and the improvement degree of at least 3 items among the remaining 5 items is ≥70%. |
| Secondary | The proportion of subjects with a CDAI（Clinical Disease Activity Index） score ≤ 10 | When treating up to the 28th and 84th days | CDAI=（TJC28+SJC28+GH+EH）/4 * TJC28: Number of tender joints among 28 joints; * SJC28: Number of swollen joints among 28 joints; * GH: Patient's global assessment of disease activity (VAS score, unit: 100mm); * EH: Physician's global assessment of disease activity (VAS score, unit: 100mm). Disease activity thresholds: * High: \> 22; * Moderate: \> 10 and ≤ 22; * Low: \> 2.8 and ≤ 10; * Remission: ≤ 2.8. |
| Secondary | The proportion of subjects with a CDAI（Clinical Disease Activity Index） score ≤ 2.8 | When treating up to the 28th and 84th days | CDAI=（TJC28+SJC28+GH+EH）/4 - TJC28: Number of tender joints among 28 joints; - SJC28: Number of swollen joints among 28 joints; - GH: Patient's global assessment of disease activity (VAS score, unit: 100mm); - EH: Physician's global assessment of disease activity (VAS score, unit: 100mm). Disease activity thresholds: - High: \> 22; - Moderate: \> 10 and ≤ 22; - Low: \> 2.8 and ≤ 10; - Remission: ≤ 2.8. |
| Secondary | The change of CDAI（Clinical Disease Activity Index） score compared with the baseline | When treating up to the 28th and 84th days | CDAI=（TJC28+SJC28+GH+EH）/4 - TJC28: Number of tender joints among 28 joints; - SJC28: Number of swollen joints among 28 joints; - GH: Patient's global assessment of disease activity (VAS score, unit: 100mm); - EH: Physician's global assessment of disease activity (VAS score, unit: 100mm). Disease activity thresholds: - High: \> 22; - Moderate: \> 10 and ≤ 22; - Low: \> 2.8 and ≤ 10; - Remission: ≤ 2.8. |
| Secondary | The proportion of subjects with an SDAI（Simplified Disease Activity Index） score ≤ 11 | When treating up to the 28th and 84th days | SDAI=（TJC28+SJC28+CRP+GH+EH）/5 * TJC28: Number of tender joints among 28 joints; * SJC28: Number of swollen joints among 28 joints; * CRP: C-reactive Protein; * GH: Patient's global assessment of disease activity (VAS score, unit: 100mm); * EH: Physician's global assessment of disease activity (VAS score, unit: 100mm). Disease activity thresholds: * High: \> 26; * Moderate: \> 11 and ≤ 26; * Low: \> 3.3 and ≤ 11; * Remission: ≤ 3.3. |
| Secondary | The proportion of subjects with an SDAI （Simplified Disease Activity Index）score ≤ 3.3 | When treating up to the 28th and 84th days | SDAI=（TJC28+SJC28+CRP+GH+EH）/5 * TJC28: Number of tender joints among 28 joints; * SJC28: Number of swollen joints among 28 joints; * CRP: C-reactive Protein; * GH: Patient's global assessment of disease activity (VAS score, unit: 100mm); * EH: Physician's global assessment of disease activity (VAS score, unit: 100mm). Disease activity thresholds: * High: \> 26; * Moderate: \> 11 and ≤ 26; * Low: \> 3.3 and ≤ 11; * Remission: ≤ 3.3. |
| Secondary | Change in SDAI （Simplified Disease Activity Index）score from baseline | When treating up to the 28th and 84th days | SDAI=（TJC28+SJC28+CRP+GH+EH）/5 * TJC28: Number of tender joints among 28 joints; * SJC28: Number of swollen joints among 28 joints; * CRP: C-reactive Protein; * GH: Patient's global assessment of disease activity (VAS score, unit: 100mm); * EH: Physician's global assessment of disease activity (VAS score, unit: 100mm). Disease activity thresholds: * High: \> 26; * Moderate: \> 11 and ≤ 26; * Low: \> 3.3 and ≤ 11; * Remission: ≤ 3.3. |
| Secondary | The change of HAQ-DI（Health Assessment Questionnaire-Disability Index Score） score compared with the baseline | When treating up to the 28th and 84th days | The HAQ-DI scale consists of 20 questions, each scored on a 4-point scale: 0 points for "no difficulty", 1 point for "some difficulty", 2 points for "great difficulty", and 3 points for "unable to perform". The total score is 0-60 points.The higher the score, the worse the function or mood. |
| Secondary | The changes of the scores of each dimension of the quality of life (SF-36,36-item Short-Form) compared with the baseline respectively. | When treating up to the 28th and 84th days | 1. Calculation of raw scores: For each question, assign the corresponding score according to the answer option. Usually, the options are arranged in the order from "best" to "worst" and given corresponding score values (such as a 5-point scale, 4-point scale, or 3-point scale). Calculate the total raw score for each dimension. 2. Calculation of converted scores: Since the number of questions and score ranges in different dimensions may vary, it is necessary to convert raw scores into standard scores (i.e., converted scores) for comparison and analysis. The calculation method of converted scores is usually: (Raw score - Minimum possible raw score of the dimension) / (Maximum possible raw score of the dimension - Minimum possible raw score of the dimension) × 100. In this way, the converted score of each dimension will be standardized between 0 and 100, facilitating comparison and analysis. A higher score indicates a better state of health. |
| Secondary | The change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score in disease treatment compared with the baseline. | When treating up to the 28th and 84th days | The FACIT-Fatigue consists of 13 questions, each scored on a 5-point scale (0-4 points), with a total score ranging from 0 to 52 points. A higher score indicates a more severe degree of fatigue in the patient. |
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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