Trial · NCT04157348
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Percentage of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 4 mg/day (main remission definition) at both Weeks 36 and 48. |
| Primary | Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Supportive endpoint: Proportion of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 7.5 mg/day (supportive remission definition) at both Weeks 36 and 48. |
| Secondary | Total Accrued Duration of Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks. | Total accrued duration of remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week. |
| Secondary | Total Accrued Duration of Sustained Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks | Total accrued duration of sustained remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week. |
| Secondary | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | from baseline to end of DB period, 52 Weeks | Time from randomization to first Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse, where relapse is defined as any of the following: * Active vasculitis (BVAS \> 0); OR * Active asthma symptoms and/or signs with a corresponding worsening in ACQ-6 score; OR * Active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions; warranting any of the following: * An increased dose of OCS therapy to \> 4 mg/day prednisolone total daily dose; OR * An increased dose or addition of immunosuppressive therapy; OR * Hospitalization related to EGPA worsening Calculated using the Kaplan-Meier technique. |
| Secondary | Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate | from baseline to end of DB period, 52 Weeks | Annualized Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse rate through end of DB treatment period. The estimate of annualized relapse rate (relapses per year) and the corresponding 95% CIs were calculated using a negative binomial model. The response variable in the model is the number of relapses experienced by a subject up to Week 52. The logarithm of the subject's corresponding follow-up time up to Week 52 was used as an offset variable to adjust for subjects having different follow-up times during which the events occur. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region. |
| Secondary | Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52 | last 4 weeks of DB period | Average daily dose of prednisolone/prednisone and change from baseline during Week 48 through 52, or last 28 days prior to last double-blind assessment for those that withdrew |
| Secondary | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Proportion of patients with average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: 0 mg; \>0 to ≤ 4 mg; \> 4 to ≤ 7.5 mg and \> 7.5 mg |
| Secondary | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Percentage reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: no reduction or withdrawal from treatment; \< 25% reduction; 25 to \< 50% reduction; 50 to \<75% reduction; 75 to \< 100% reduction; 100% reduction. |
| Secondary | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Proportion of subjects with reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: \>= 50% reduction; 100% reduction; OCS dose \<= 4 mg/day. |
| Secondary | Proportion of Subjects Who Achieve Clinical Benefit | from baseline to end of DB period, 52 Weeks | Proportion of subjects who achieved any clinical benefit definition 1 (defined as any of the following: * Main remission at any time in DB period * \>= 50% reduction in OCS dose in Weeks 48 to 52 * EGPA relapse free in DB period) and subjects who achieved complete response definition 1 (defined as meeting all the definition 1 criteria above.) |
| Secondary | Proportion of Patients Who Have Achieved Remission Within the First 24 Weeks and Remained in Remission for Remainder of the Double-blind Treatment Period | from baseline to end of DB period, 52 Weeks | Proportion of patients who have achieved remission within the first 24 weeks and remained in remission for remainder of the double-blind treatment period |
| Secondary | Change From Baseline in Birmingham Vasculitis Activity Score (BVAS) | from baseline to end of DB period, 52 Weeks | Birmingham Vasculitis Activity Score (BVAS) change from baseline by timepoint up to week 52. The 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 total score on all 9 organ systems gives an indication of the disease activity of each patient at the time of scoring. Total scores range from 0 to 63, with higher scores indicating more active vasculitis. |
| Secondary | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FEV1 (L) | from baseline to end of DB period, 52 Weeks | Pre-bronchodilator (BD) Forced Expiratory Volume during first second (FEV1) change from baseline by timepoint up to week 52 |
| Secondary | Spirometry Change From Baseline by Timepoint up to Week 52: Pre-BD FVC (L) | from baseline to end of DB period, 52 Weeks | Pre-bronchodilator (BD) Forced vital capacity (FVC) change from baseline by timepoint up to week 52 |
| Secondary | Change From Baseline in Vasculitis Damage Index (VDI) | from baseline to end of DB period, 52 Weeks | Vasculitis Damage Index (VDI) change from baseline by timepoint up to week 52. The VDI is divided into 11 organ systems and records items of damage, due to vasculitis, treatment or unrelated, that have occurred since the onset of vasculitis. Completion of the form provides a numerical score, ranging from 0 to 64, with a higher score indicating more damage. |
| Secondary | Change From Baseline in Asthma Control Questionnaire (6-item Version) (ACQ-6) | from baseline to end of DB period, 52 Weeks | Asthma Control Questionnaire (6-item version) (ACQ-6) change from baseline by timepoint up to week 52. The ACQ-6 score is calculated by taking the mean of 6 equally weighted domains, with a range of 0 (well controlled) to 6 (extremely poorly controlled). |
| Secondary | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Physical Component Summary (PCS) | from baseline to end of DB period, 52 Weeks | Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Physical Component Summary (PCS) change from baseline by timepoint up to week 52. PCS score ranges from 10.8 to 75.5, where a higher score indicates better health. |
| Secondary | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) Component: Mental Component Summary (MCS) | from baseline to end of DB period, 52 Weeks | Short Form 36-item health survey (version 2, acute recall) (SF-36v2) component Mental Component Summary (MCS) change from baseline by timepoint up to week 52. MCS score ranges from 5.6 to 69.7, where a higher score indicates better health. |
| Secondary | Change From Baseline in Sino-nasal Outcome Test-22 (SNOT-22) Total Score | from baseline to end of DB period, 52 Weeks | Sino-nasal Outcome Test-22 (SNOT-22) total score change from baseline by timepoint up to week 52. Patient reported symptom severity and symptom impact over the previous 2 weeks on 22 items are captured via a 6-point scale (0 = no problem to 5 = problem as bad as it can be). The total score is the sum of item scores and ranges from 0 to 110 (higher scores indicate poorer outcomes). |
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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