Trial · NCT02222155
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 | Incidence of Adverse Events | Baseline to Day 85 | This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms. |
| Primary | Proportion of Patients Achieving Disease Response Based on BVAS at Day 85 | Day 85 | Proportion of Patients achieving 50% reduction in the Birmingham Vasculitis Activity Score \[BVAS\] at Day 85 and no worsening in any body system component at day 85 |
| Secondary | Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85. | Day 85 | Proportion of subjects achieving disease remission based on Birmingham Vasculitis Activity Score (BVAS) defined as 0 at Day 85. |
| Secondary | Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85. | Day 29 and 85 | Proportion of subjects achieving early disease remission based on Birmingham Vasculitis Activity Score (BVAS) score of 0 at Days 29 and 85. |
| Secondary | Percent Change From Baseline to Day 85 in BVAS. | Baseline to Day 85 | The Birmingham Vasculitis Activity (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health. |
| Secondary | Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85 | Day 85 | Renal responses among patients (who had hematuria or albuminuria at baseline determined secondary to ANCA-associated vasculitis) were defined as improvement in the following parameters of renal vasculitis: (1) increase from baseline to day 85 in eGFR \[Modification of Diet in Renal Disease (MDRD equation)\], (2) decrease from baseline to day 85 in hematuria (microscopic count of urinary red blood cells \[RBC\]), and (3) decrease from baseline to day 85 in albuminuria (first morning urinary albumin:creatinine ratio). |
| Secondary | Change in Estimated Glomerular Filtration Rate at Day 85 | Baseline to Day 85 | Mean Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula, for patients with renal disease at baseline. |
| Secondary | Percentage Change in Estimated Glomerular Filtration Rate at Day 85 | Baseline to Day 85 | Mean Percentage Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula. |
| Secondary | Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85 | Baseline to Day 85 | Mean Percent Change of Urinary Red Blood Cells (UBC) in Patients in Hematuria at Baseline. |
| Secondary | Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85 | Baseline to Day 85 | Mean Percent Change of Urinary Albumin:Creatinine Ratio in Patients with Albuminuria at Baseline |
| Secondary | Percent Change of Urinary MCP-1:Creatinine Ratio From Baseline to Day 85 | Baseline to Day 85 | Mean Percent Change of Urinary monocyte chemoattractant protein (MCP-1:creatinine) ratio from Baseline |
| Secondary | Change From Baseline to Day 85 in the VDI | Baseline to Day 85 | The Vasculitis Damage Index (VDI) is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health) |
| Secondary | Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2 | Baseline to Day 85 | Change from Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the Short Form-36 (SF-36v2) SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health). |
| Secondary | Mean Change From Baseline to Day 85 in Health-related Quality-of-life as Measured by the EQ-5D-5L | Baseline to Day 85 | Mean Change from baseline to Day 85 in health-related quality-of-life as measured by the Euro Quality-of-Life-5 Domains-5 Levels (EQ-5D-5L). EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health). |
| Secondary | Proportion of Subjects Requiring Rescue Glucocorticoid Treatment From Baseline to Day 85 | Baseline to Day 85 | Proportion of subjects requiring rescue glucocorticoid treatment from Baseline to Day 85 |
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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