Trial · NCT04895241
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52 | Week 52 | SRI-4 response is a composite endpoint defined by the following criteria: * Reduction from baseline of ≥4 points in systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K). * No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline. * No worsening from baseline in lupus disease activity as defined by \<0.3-point increase on 3-point Physician's Global Assessment (PGA) - Visual Analog Scale (VAS). * No violation to protocol-specified medication rules. |
| Secondary | Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG) - Based Combined Lupus Assessment (BICLA) Response at Week 52 | Week 52 | The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BICLA is a composite endpoint defined as BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at baseline improved to grade C or D, no BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 grade A or greater than 1 new BILAG-2004 grade B, no worsening in the SLEDAI-2K total score compared with Baseline, no worsening from Baseline in lupus disease activity defined by \< 0.3-point increase on 3-point PGA-VAS and no violation to protocol-specified medication rules. |
| Secondary | Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52 | Week 52 | Joint-50 response is 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts. |
| Secondary | Percentage of Participants With Oral Corticosteroid(s) (OCS) ≥10 milligrams per day (mg/day) at Baseline With OCS Reduction to ≤7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52 | Week 40 to Week 52 | No worsening of the disease is defined as no new BILAG-2004 grade A or less than 2 new BILAG-2004 grade B since the last visit during the Week 40 to Week 52. |
| Secondary | Percentage of Participants With a CLASI-A score ≥10 at Baseline Who Achieved a 50% Improvement From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 24 | Week 24 | Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in CLASI-A. |
| Secondary | Annualized Flare Rate Through Week 52 | Up to Week 52 | Annualized flare rate will be calculated as the total number of flares divided by the flare exposure time in days, and the ratio multiplied by 365.25. |
| Secondary | Change from Baseline in Physician's Global Assessment (PGA) Visual Analog Scale (VAS) Score by Visit | Up to Week 52 | The PGA is an Investigator-administered assessment used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participant's current disease activity from a score of 0 (none) to 3 (severe), with the assessment made relative to the most severe state of SLE. |
| Secondary | Percentage of Participants Who Achieved a BILAG-BICLA Response by Visit | Up to Week 52 | The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BICLA is a composite endpoint defined as BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at baseline improved to grade C or D, no BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 grade A or greater than 1 new BILAG-2004 grade B, no worsening in the SLEDAI-2K total score compared with Baseline, no worsening from Baseline in lupus disease activity defined by \< 0.3-point increase on 3-point PGA-VAS and no violation to protocol-specified medication rules. |
| Secondary | Time to Onset of SRI-4 Response Sustained Through Week 52 | Up to Week 52 | SRI-4 response is a composite endpoint defined by the following criteria: * Reduction from baseline of ≥4 points in SLEDAI-2K. * No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline. * No worsening from baseline in lupus disease activity as defined by \<0.3-point increase on 3-point PGA -VAS. * No violation to protocol-specified medication rules. |
| Secondary | Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit | Up to Week 52 | SRI-4 response is a composite endpoint defined by the following criteria: * Reduction from baseline of ≥4 points in SLEDAI-2K. * No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline. * No worsening from baseline in lupus disease activity as defined by \<0.3-point increase on 3-point PGA -VAS. * No violation to protocol-specified medication rules. The SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively. |
| Secondary | Percentage of Participants With Joint-50 Response by Visit | Up to Week 52 | Joint-50 response is 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts. |
| Secondary | Percentage of Participants With Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit | Up to Week 52 | Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-20, -50, -70 and -90 represent 20%, 50%, 70% or 90% improvement from baseline in CLASI-A score, respectively. |
| Secondary | Percentage of Participants With Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤ 1 by Visit | Up to Week 52 | Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-A ≤1 represent the absolute score ≤1 in CLASI-A by visit. |
| Secondary | Percentage of Participants With Severe Flares Through Week 52 | Up to Week 52 | A SFI severe flare is defined as any of the following: 1. Change in SLEDAI instrument score to \> 12. 2. New or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets \< 60,000/mL; or hemolytic anemia with hemoglobin \< 7 g/dL or decrease in hemoglobin \>3 g/dL AND requiring: doubling prednisone dose, increase to \> 0.5 mg/kg/day or hospitalization. 3. Increase in prednisone dose to \> 0.5 mg/kg/day. 4. New requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity. 5. Hospitalization for SLE activity. 6. Increase in PGA score to \> 2.5. |
| Secondary | Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit | Up to Week 52 | BILAG-2004 severe flare is defined as an A score for items recorded as worse or new. BILAG-2004 is evaluated by scoring each item of a list of signs and symptoms given as 4 = new; 3 = worse; 2 = same; 1 = improving; 0 = not present; and ND = not done. |
| Secondary | Time to First Severe Flare as defined by the Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) | Up to Week 52 | SFI severe flare is defined any of the following: change in SLEDAI instrument score to \>12; or new or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets \<60,000 per milliliter (/mL); or hemolytic anemia with hemoglobin \<7 grams per deciliter (g/dL) or decrease in hemoglobin \>3 g/dL and requiring: doubling prednisone dose; or increase to \>0.5 milligrams per kilogram per day (mg/kg/day) or hospitalization; or increase in prednisone dose to \>0.5 mg/kg/day; or new requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity; or hospitalization for SLE activity; or increase in PGA score to \>2.5. |
| Secondary | Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS) | Up to Week 52 | LLDAS is a composite endpoint defined as: * SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and * No new features of lupus disease activity compared with the previous assessment; and * Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) PGA ≤ 1; and * Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and * Standard maintenance doses of immunosuppressive drugs and approved biological agents. |
| Secondary | Percentage of Participants With Sustained LLDAS as Defined by the Number of Participants With ≥ 3, ≥ 5, and ≥ 7 Consecutive Visits in LLDAS up to and Including Week 52 | Up to Week 52 | LLDAS is a composite endpoint defined as: * SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and * No new features of lupus disease activity compared with the previous assessment; and * SELENA-SLEDAI PGA ≤ 1; and * Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and * Standard maintenance doses of immunosuppressive drugs and approved biological agents. |
| Secondary | Percentage of Participants who Achieved LLDAS at Week 52 | Week 52 | LLDAS is a composite endpoint defined as: * SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and * No new features of lupus disease activity compared with the previous assessment; and * SELENA-SLEDAI PGA ≤ 1; and * Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and * Standard maintenance doses of immunosuppressive drugs and approved biological agents. |
| Secondary | Percentage of Participants who Achieved SLEDAI-2K Improvement at Week 52 | Week 52 | The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms), where higher scores represent increased disease activity. SLEDAI-2K improvement is defined as a reduction from Baseline of ≥ 4 points in SLEDAI-2K score. |
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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