Trial · NCT07191444
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of subjects achieving clinical inactive disease (CID) at Week 24, where CID is defined as the absence of Still's disease-related symptoms with normal ESR or CRP levels. | At Week 24 from initiation of treatment | |
| Secondary | Proportion of subjects achieving afebrile status with either ≥50% reduction in CRP levels or CRP within normal range at Weeks 2, 4, and 8. | At Weeks 2, 4, and 8 after treatment initiation | Efficacy Endpoints |
| Secondary | Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range at Week 12. | At Week 12 after treatment initiation | Efficacy Endpoints |
| Secondary | Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.2 mg/kg/day at Week 12. | At Week 12 after treatment initiation | Efficacy Endpoints |
| Secondary | Proportion of subjects achieving afebrile status with either ≥70% reduction in CRP levels or CRP within normal range, and glucocorticoid dose ≤0.1 mg/kg/day at Week 12. | At Week 12 after treatment initiation | Efficacy Endpoints |
| Secondary | Proportion of subjects achieving clinical inactive disease (CID) with discontinuation of glucocorticoids | At Week 24 after treatment initiation | Efficacy Endpoints |
| Secondary | Proportion of subjects without disease relapse at Weeks 12 and 24. | At Weeks 12 and 24 after treatment initiation | Efficacy Endpoints |
| Secondary | ACR30, ACR50, ACR70, and ACR90 response rates at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Secondary | Change from baseline in ferritin levels at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Secondary | Change from baseline in cytokine levels (including sIL-2R) at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Secondary | Change from baseline in ESR at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Secondary | Change from baseline in CRP levels at Weeks 2, 4, 8, 12, 16, 20, and 24 | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Secondary | Change from baseline in Pouchot score at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints. Pouchot score ranges from 0 to 12 points, with higher scores indicating a poorer outcome. |
| Secondary | Change from baseline in glucocorticoid dose at Weeks 2, 4, 8, 12, 16, 20, and 24. | At Weeks 2, 4, 8, 12, 16, 20, and 24 after treatment initiation | Efficacy Endpoints |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Through study completion, an average of 1 year |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07191444/registered