Trial · NCT04294667
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48 | Week 48 | Study participants were considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following were fulfilled: * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to \[≤\] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; and * No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and * No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as \[≤\] 10 millimeter (mm) increase on a 100 mm visual analog scale (VAS). |
| Secondary | Percentage of Participants With Achievement of BICLA Response at Week 24 | Week 24 | Study participants were considered to be a BICLA responder if all of the following were fulfilled: * BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; and * No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and * No worsening in the PGA compared to Baseline Visit defined as ≤ 10 mm increase on a 100 mm VAS. |
| Secondary | Percentage of Participants With Achievement of BICLA Response at Week 12 | Week 12 | Study participants were considered to be a BICLA responder if all of the following were fulfilled: * BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤ 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active and * No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and * No worsening in the PGA compared to Baseline Visit defined as ≤ 10 mm increase on a 100 mm VAS. |
| Secondary | Percentage of Participants With Achievement of Prevention of Severe British Isles Lupus Assessment Group (BILAG) Flares (Severe BILAG Flare-free) Through Week 48 | During Treatment Period up to Week 48 | A severe BILAG flare was defined as a british isles lupus assessment group disease activity index 2004 (BILAG 2004) Grade A in any system due to individual items that were new or worse qualifying for the Grade A. Determination of items that were new or worse and were qualifying for the Grade A were according to the supplementary information for the numerical scoring of the BILAG-2004 index. Here, Grade A ("Active"): Severely active disease (sufficient to require systemic immunosuppressant or anticoagulant therapy. |
| Secondary | Percentage of Participants With Achievement of Lupus Low Disease Activity State (LLDAS) in ≥50% of Post-Baseline Visits Through Week 48 | During Treatment Period up to Week 48 | The LLDAS includes domains that capture the absence of organ-threatening disease activity and harmful treatment burden. The LLDAS is defined as: * SLEDAI-2K score was ≤4 with no activity in major organ systems. * No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at the previous visit. * PGA ≤ 33 mm. * Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤ 7.5 mg per day. * Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol, defined as no increase in dose in the past 12 weeks and no dose higher than allowed as per protocol. |
| Secondary | Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Week 48 | From Baseline (Day 1) to Week 48 | The SLEDAI-2K is a global index which includes 24 clinical and laboratory variables such as antibodies, renal, and hematological components measured 30 days before, and at the timepoint of assessment. The variables were weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies (anti-dsDNA positive or negative) and low complement, as well as some renal and hematologic parameters. The total score falls between 0 and 105, with higher scores representing increased disease activity. Mixed effects models for repeated measurements (MMRM). |
| Secondary | Percentage of Participants With Achievement of BILAG Improvement Without Worsening at Week 48 | Week 48 | The BILAG improvement without worsening defined as A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B Score. Here, score A ("Active"): Severely active disease (sufficient to require systemic immunosuppressant or anticoagulant therapy; score B ("Beware"): Moderately active disease (requires low dose or local immunosuppressant therapy or symptomatic therapy; score C ("Contentment"): Mild stable disease (no indication for changes in treatment); score D ("Discount"): Inactive now but previously active. |
| Secondary | Change From Baseline in Physician's Global Assessment (PGA) at Week 48 | From Baseline (Day 1) to Week 48 | The PGA is a measure of systemic lupus erythematosus (SLE) signs and symptoms by the physician using a visual analog scale of 0 to 100mm, Where 0 indicate "very good", asymptomatic, and no limitation of normal activity and 100 indicate "severe disease". |
| Secondary | Percentage of Participants With Achievement of Systemic Lupus Erythematosus Responder Index Response - 4 (SRI-4) Response at Week 48 | Week 48 | The SRI-4 define responders as meeting all of the following criteria: * Reduction in SLEDAI-2K score of ≥ 4. * No shift from BILAG 2004 Grade B, C, D, or E to A post-Baseline. Here, Grade A ("Active"): Severely active disease; Grade B ("Beware"): Moderately active disease; Grade C ("Contentment"): Mild stable disease; Grade D ("Discount"): Inactive now but previously active; Grade E ("Excluded"): Never affected. * No more than 1 shift from BILAG 2004 Grade C, D, or E to B post-Baseline. * No worsening in the PGA compared to study entry defined as ≤ 10 mm increase on a 100 mm visual analog scale, equivalent to less than a 10 mm increase in the PGA compared to study entry score. |
| Secondary | Percentage of Participants With Achievement of Prevention of Moderate/Severe BILAG Flares (Moderate/Severe BILAG Flare-free) Through Week 48 | During Treatment Period up to Week 48 | Achievement of prevention of moderate/severe BILAG flares through Week 48 was defined as the percentage of participants with no moderate or severe flare through Week 48. A severe BILAG flare was defined as a BILAG 2004 Grade A in any system due to individual items that were new or worse qualifying for the Grade A. Determination of items that were new or worse and were qualifying for the Grade A, according to the supplementary information for the numerical scoring of the BILAG-2004 index. A moderate BILAG flare was defined as 2 or more BILAG 2004 Grade B due to individual items that were new or worse and were qualifying for the Grade B in any system. Determination of items that were new or worse qualifying for the Grade B, according to the supplementary information for the numerical scoring of the BILAG- 2004 index. Here, Grade A ("Active"): Severely active disease; Grade B ("Beware"): Moderately active disease. |
| Secondary | Time to Severe BILAG Flare Through Week 48 | During Treatment Period up to Week 48 | Time to severe BILAG flare (the event) through Week 48 was defined as the time from randomization until the start of the event. A severe BILAG flare was defined as a BILAG 2004 Grade A in any system due to individual items that were new or worse qualifying for the Grade A. Determination of items that were new or worse and were qualifying for the Grade A, according to the supplementary information for the numerical scoring of the BILAG-2004 index. Here, Grade A ("Active"): Severely active disease. |
| Secondary | Time to Moderate/Severe BILAG Flare Through Week 48 | During Treatment Period up to Week 48 | Time to moderate/severe BILAG flare (the event) through Week 48 was defined as the time from randomization until the start of the event. Moderate BILAG flare was defined as 2 or more BILAG 2004 Grade B due to individual items that were new or worse and were qualifying for the Grade B in any system. Determination of items that were new or worse qualifying for the Grade B, according to the supplementary information for the numerical scoring of the BILAG-2004 index. Severe BILAG flare was defined as a BILAG 2004 Grade A in any system due to individual items that were new or worse qualifying for the Grade A. Determination of items that were new or worse and are qualifying for the Grade A, according to the supplementary information for the numerical scoring of the BILAG-2004 index. Here, Grade A ("Active"): Severely active disease; Grade B ("Beware"): Moderately active disease. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 54) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Treatment-emergent AEs were those with onset date on or after the first administration of study drug, and up to 60 days after last dose. |
| Secondary | Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 54) | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; and Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. Treatment-emergent AEs were those with onset date on or after the first administration of study drug, and up to 60 days after last dose. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events of Special Interest During the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 54) | An adverse event of special interest (AESIs) is any AE that a regulatory authority has mandated be reported on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a product/compound. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events of Special Monitoring During the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 54) | An AE of special monitoring is a product-specific AEs, adverse reactions, or safety topics considered as requiring special monitoring by UCB. |
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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